- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00442546
Efficacy And Safety Of Pregabalin For Pain Following Total Knee Replacement
January 20, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
A Multicenter, Double-Blind Randomized, Placebo-Controlled Study Of The Efficacy And Safety Of Pregabalin In The Treatment Of Subjects With Post-Operative Pain Following Total Knee Arthroplasty (TKA)
Pregabalin added to the standard of care with dosing starting preoperatively and continuing for up to 6 weeks post surgery will decrease the intensity of post-operative pain following total knee replacement.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
307
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Northport, Alabama, United States, 35476
- Pfizer Investigational Site
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Tuscaloosa, Alabama, United States, 35406
- Pfizer Investigational Site
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Tuscaloosa, Alabama, United States, 35401
- Pfizer Investigational Site
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Arizona
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Phoenix, Arizona, United States, 85023
- Pfizer Investigational Site
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Arkansas
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Little Rock, Arkansas, United States, 72205
- Pfizer Investigational Site
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Florida
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Miami, Florida, United States, 331036
- Pfizer Investigational Site
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Vero Beach, Florida, United States, 32960
- Pfizer Investigational Site
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Illinois
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Chicago, Illinois, United States, 60612
- Pfizer Investigational Site
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Galesburg, Illinois, United States, 61401
- Pfizer Investigational Site
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Louisiana
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Lafayette, Louisiana, United States, 70503
- Pfizer Investigational Site
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New Iberia, Louisiana, United States, 70563
- Pfizer Investigational Site
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Maryland
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Baltimore, Maryland, United States, 21218
- Pfizer Investigational Site
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New Jersey
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Egg Harbor Township, New Jersey, United States, 08234
- Pfizer Investigational Site
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Pomona, New Jersey, United States, 08205
- Pfizer Investigational Site
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Voorhees, New Jersey, United States, 08043
- Pfizer Investigational Site
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New York
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New York, New York, United States, 10021
- Pfizer Investigational Site
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North Carolina
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Charlotte, North Carolina, United States, 28207
- Pfizer Investigational Site
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Ohio
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Columbus, Ohio, United States, 43214
- Pfizer Investigational Site
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Columbus, Ohio, United States, 43215
- Pfizer Investigational Site
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Upper Arlington, Ohio, United States, 43220
- Pfizer Investigational Site
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Pennsylvania
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Allentown, Pennsylvania, United States, 18103
- Pfizer Investigational Site
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King Of Prussia, Pennsylvania, United States, 19406
- Pfizer Investigational Site
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Philadelphia, Pennsylvania, United States, 19107
- Pfizer Investigational Site
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Pittsburgh, Pennsylvania, United States, 15232
- Pfizer Investigational Site
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Pittsburgh, Pennsylvania, United States, 15213-2582
- Pfizer Investigational Site
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Texas
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Dallas, Texas, United States, 75390
- Pfizer Investigational Site
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Houston, Texas, United States, 77030
- Pfizer Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subjects with osteoarthritis (OA) undergoing elective TKA under regional anesthesia (neuroaxial with or without peripheral nerve block).
- Subjects able to demonstrate sufficient psychomotor dexterity and cognitive capacity to use Patient Controlled Analgesia/Patient Controlled Epidural Analgesia if used as part of the standard of care.
- The subject's preoperative health is graded as American Society of Anesthesiology Class 1 to Class 3
Exclusion Criteria:
- Subjects undergoing revision, unicompartmental, bilateral total knee arthroplasty or subjects with planned second knee total knee arthroplasty at time of present procedure.
- Subjects with inflammatory arthritides (i.e., rheumatoid arthritis, lupus, ankylosing spondylitis, psoriatic arthritis); Lyme disease.
- Subjects with fibromyalgia and or other chronic pain syndromes
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 1
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150 milligram (mg)/ day (double blind)
300 mg/day (double blind)
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Experimental: 2
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150 milligram (mg)/ day (double blind)
300 mg/day (double blind)
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Placebo Comparator: 3
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Placebo
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Subject Reported Worst Pain Score in Daily Diaries Using the Worst Pain Item of the Modified Brief Pain Inventory - Short Form (m-BPI-sf)
Time Frame: 48 hours after surgery
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The mBPI-SF is a self administered questionnaire developed to assess pain severity and pain interference with functional activities during a 24-hour period prior to evaluation.
For the Worst Pain item of the m-BPI-sf scale (11 point Likert scale; range: 0 [no pain] to 10 [pain as bad as you can imagine]), subjects were asked to rate their pain by marking an "X" in one of the ten boxes that best described their pain at its worst in the last 24 hours post surgery and at least 12 hours after discontinuation of the peripheral nerve block or neuroaxial block.
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48 hours after surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cumulative Total Amount of Opioids Used During the Entire Hospital Stay
Time Frame: 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours, 168 hours, 192 hours, 216 hours
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Total cumulative dose calculated as mg of oral morphine equivalent and included opioids given by any route (patient controlled analgesia [PCA] pump, parenteral bolus or oral).
Results for daily total not including pregabalin (not an opioid).
Statistical model included main effect of treatment group and center. 1 subject at 144 h, 300 mg=non-missing data.
Due to small sample size (N=1, 300 mg; N=5, other groups) and large opioid consumption for another subject in same center, least squares mean (300 mg, 144 h) is negative.
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24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours, 168 hours, 192 hours, 216 hours
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Opioids Used Post Discharge
Time Frame: Week 2, Week 4, Week 6/Early Termination (ET)
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The amount of opioid use was calculated as mg of oral morphine equivalent and included opioids administered by any route (PCA pump, parenteral bolus, or oral).
Weeks 2, 4, and 6 total daily doses were calculated by adding the cumulative doses during the 2 week period prior to the visit and dividing them by the number of days in the period.
This outcome measure does not include pregabalin as it is not an opioid.
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Week 2, Week 4, Week 6/Early Termination (ET)
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Analgesics Used During the Hospital Stay (Acetylsalicylic Acid, Ketorolac, and Paracetamol)
Time Frame: 24 hours, 48 hours, 72 hours
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Total dose for in-hospital visits was the total dose for the day.
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24 hours, 48 hours, 72 hours
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Analgesics Used Post Discharge (Acetylsalicylic Acid [Week 2] and Paracetamol [Weeks 2, 4, and 6]
Time Frame: Week 2, Week 4, Week 6/ET
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Weeks 2, 4, and 6 total daily doses were calculated by adding the cumulative doses during the 2 week period prior to the visit and dividing them by the number of days in the period.
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Week 2, Week 4, Week 6/ET
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Analgesics Used Post Discharge (Ibuprofen) for the Pregabalin 150 mg and Placebo Treatment Groups
Time Frame: Week 2, Week 4, Week 6/ET
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Weeks 2, 4, and 6 total daily doses were calculated by adding the cumulative doses during the 2 week period prior to the visit and dividing them by the number of days in the period.
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Week 2, Week 4, Week 6/ET
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Analgesics Used Post Discharge (Ibuprofen) for the Pregabalin 300 mg Treatment Group
Time Frame: Week 2, Week 4, Week 6/ET
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Weeks 2, 4, and 6 total daily doses were calculated by adding the cumulative doses during the 2 week period prior to the visit and dividing them by the number of days in the period.
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Week 2, Week 4, Week 6/ET
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Analgesics Used Post Discharge (Acetylsalicylic Acid) for the Pregabalin 150 mg and Placebo Treatment Groups at Week 4
Time Frame: Week 4
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Week 4 total daily dose was calculated by adding the cumulative doses during the 2 week period prior to the visit and dividing them by the number of days in the period.
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Week 4
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Analgesics Used Post Discharge (Acetylsalicylic Acid) for the Pregabalin 300 mg Treatment Group at Week 4
Time Frame: Week 4
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Week 4 total daily dose was calculated by adding the cumulative doses during the 2 week period prior to the visit and dividing them by the number of days in the period.
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Week 4
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Analgesics Used Post Discharge (Acetylsalicylic Acid) for the Pregabalin 150 mg and Placebo Treatment Groups at Week 6/ET
Time Frame: Week 6/ET
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Week 6 total daily dose was calculated by adding the cumulative doses during the 2 week period prior to the visit and dividing them by the number of days in the period.
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Week 6/ET
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Analgesics Used Post Discharge (Acetylsalicylic Acid) for the Pregabalin 300 mg and Placebo Treatment Groups at Week 6/ET
Time Frame: Week 6/ET
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Week 6 total daily dose was calculated by adding the cumulative doses during the 2 week period prior to the visit and dividing them by the number of days in the period.
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Week 6/ET
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The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the Opioid-Related Symptom Distress Scale (OR-SDS) - Frequency Composite Score
Time Frame: 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Discharge, Week 2, Week 4, Week 6/ET
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The OR-SDS was used to assess subject-reported levels of frequency concerning 10 symptoms known to be associated with opioid medication usage: fatigue, drowsiness, inability to concentrate, nausea, dizziness, constipation, itching, difficulty with urination, confusion, and retching/vomiting.
Symptom frequency was rated as: 1=rarely, 2=occasionally, 3=frequently, or 4=almost constantly.
The average score for each symptom was calculated by taking the mean of patient-reported score.
Total possible frequency score: 0 (less frequent) to 4 (more frequent).
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24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Discharge, Week 2, Week 4, Week 6/ET
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The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Severity Composite Score
Time Frame: 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Discharge, Week 2, Week 4, Week 6/ET
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The OR-SDS was used to assess subject-reported levels of severity concerning 10 symptoms known to be associated with opioid medication usage: fatigue, drowsiness, inability to concentrate, nausea, dizziness, constipation, itching, difficulty with urination, confusion, and retching/vomiting.
Symptom severity was rated as: 1=slight, 2=moderate, 3=severe, or 4=very severe.
The average score for each symptom was calculated by taking the mean of patient-reported score.
Total possible severity score: 0 (less severe) to 4 (more severe).
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24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Discharge, Week 2, Week 4, Week 6/ET
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The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Degree of Bother Composite Score
Time Frame: 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Discharge, Week 2, Week 4, Week 6/ET
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The OR-SDS was used to assess subject-reported level of degree of bother concerning 10 symptoms known to be associated with opioid medication usage: fatigue, drowsiness, inability to concentrate, nausea, dizziness, constipation, itching, difficulty with urination, confusion, and retching/vomiting.
Symptom degree of bother was rated as: 1=not at all, 2=a little bit, 3=somewhat, 4=quite a bit, or 5=very much.
Average score for each symptom was calculated by taking the mean of patient-reported score.
Total possible degree of bother score: 0 (less degree of bother) to 5 (greater degree of bother).
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24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Discharge, Week 2, Week 4, Week 6/ET
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The Effect of Pregabalin Compared to Placebo on the Occurrence of Opioid-Related Symptoms as Assessed Using the OR-SDS - Overall Composite Score
Time Frame: 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Discharge, Week 2, Week 4, Week 6/ET
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The OR-SDS assessed subject-reported levels of frequency, severity and degree of bother for 10 symptoms known to be associated with opioid medication usage: fatigue, drowsiness, inability to concentrate, nausea, dizziness, constipation, itching, difficulty with urination, confusion, retching and vomiting.
The overall composite score was the average across frequency, severity, and degree of bother scores.
Total possible score: 0 (better) to 4.34 (worse).
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24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Discharge, Week 2, Week 4, Week 6/ET
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Total Clinically Meaningful Event (CME) Score
Time Frame: 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Discharge, Week 2, Week 4, and Week 6/ET
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CMEs were defined using OR-SDS (assesses subject-reported levels of severity concerning 10 symptoms associated with opioid medication usage: fatigue, drowsiness, inability to concentrate, nausea, dizziness, constipation, itching, difficulty with urination, confusion and retching/vomiting).
CME = any symptom rated as severe or very severe, with the exception of confusion.
Confusion was defined as a CME if the severity score was at least moderate.
Total score = the sum of CMEs across symptoms.
Each CME = 1 point.
Total CME score ranges from 0 to 9.
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24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Discharge, Week 2, Week 4, and Week 6/ET
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Pain Interference Index Score as Measured by the m-BPI-sf
Time Frame: Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6
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m-BPI-sf questionnaire (7-items) assessed pain interference with functional activities during the past 24 hours.
Pain interference index = average of pain interference question (Q) 5A to 5G.
Questions were asked as follows: how, during the past 24 hours, has pain interfered with general activity (Q5A), mood (Q5B), walking ability (Q5C), normal work (outside home and housework) (Q5D), relations with other people (Q5E), sleep (Q5F), enjoyment of life (Q5G).
Scale: 0=does not interfere to 10=completely interferes.
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Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6
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Pain Interference With Relations With People as Measured by the m-BPI-sf
Time Frame: Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6
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m-BPI-sf questionnaire (7-items) assessed pain interference with functional activities during the past 24 hours.
Q5E: Subject response to 'how, during the past 24 hours, pain has interfered with your relations with other people'.
Scale: 0 = does not interfere to 10 = completely interferes.
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Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6
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Pain Interference With Enjoyment of Life as Measured by the m-BPI-sf
Time Frame: Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6
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m-BPI-sf questionnaire (7-items) assessed pain interference with functional activities during the past 24 hours.
Q5G: Subject response to 'how, during the past 24 hours, pain has interfered with your enjoyment of life'.
Scale: 0 = does not interfere to 10 = completely interferes.
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Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6
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Pain Interference With General Activity as Measured by the m-BPI-sf
Time Frame: Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6
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m-BPI-sf questionnaire (7-items) assessed pain interference with functional activities during the past 24 hours.
Q5A: Subject response to 'how, during the past 24 hours, pain has interfered with your general activity.
Scale: 0 = does not interfere to 10 = completely interferes.
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Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6
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Pain Interference With Mood as Measured by the m-BPI-sf
Time Frame: Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6
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m-BPI-sf questionnaire (7-items) assessed pain interference with functional activities during the past 24 hours.
Q5B: Subject response to 'how, during the past 24 hours, pain has interfered with your mood'.
Scale: 0 = does not interfere to 10 = completely interferes.
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Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6
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Pain Interference With Walking Ability as Measured by the m-BPI-sf
Time Frame: Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6
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m-BPI-sf questionnaire (7-items) assessed pain interference with functional activities during the past 24 hours.
Q5C: Subject response to 'how, during the past 24 hours, pain has interfered with your walking ability'.
Scale: 0 = does not interfere to 10 = completely interferes.
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Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6
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Pain Interference With Normal Work as Measured by the m-BPI-sf
Time Frame: Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6
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m-BPI-sf questionnaire (7-items) assessed pain interference with functional activities during the past 24 hours.
Q5D: Subject response to 'how, during the past 24 hours, pain has interfered with your normal work (work outside the home and housework)'.
Scale: 0 = does not interfere to 10 = completely interferes.
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Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6
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Pain Interference With Sleep as Measured by the m-BPI-sf
Time Frame: Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6
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m-BPI-sf questionnaire (7-items) assessed pain interference with functional activities during the past 24 hours.
Q5F: Subject response to 'how, during the past 24 hours, pain has interfered with your sleep'.
Scale: 0 = does not interfere to 10 = completely interferes.
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Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6
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Daily and Weekly Worst Pain During the Hospital Stay and Post Discharge Assessed by the Pain Numerical Rating Scale (NRS)
Time Frame: 12 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours, 168 hours, and 192 hours during the hospital stay, Week 2, Week 4, Week 6/ET
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Subject rated scale for worst pain over the last 24 hours.
Scores ranged from 0 (no pain) to 10 (pain as bad as you can imagine).
Weekly mean scores were calculated post-discharge.
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12 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours, 168 hours, and 192 hours during the hospital stay, Week 2, Week 4, Week 6/ET
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Daily and Weekly Average Pain During the Hospital Stay and Post Discharge Assessed by the Pain NRS
Time Frame: 12 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours, 168 hours, and 192 hours during the hospital stay, Week 2, Week 4, Week 6/ET
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Subject rated scale for average pain intensity over the last 24 hours.
Scores range from 0 (no pain) to 10 (pain as bad as you can imagine).
Weekly mean scores were calculated post-discharge.
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12 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours, 168 hours, and 192 hours during the hospital stay, Week 2, Week 4, Week 6/ET
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Current Pain During the Hospital Stay Assessed by the Pain NRS
Time Frame: 4, 8, 12, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, 104, 112, 120, 128, 136, 144, 152, 160, 168, 176, 184, and 192 hours during the hospital stay
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Subject rated scale for average pain intensity over the last 24 hours.
Pain was assessed using the question "How much pain do you have right now?" Scores range from 0 (no pain) to 10 (most possible pain).
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4, 8, 12, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, 104, 112, 120, 128, 136, 144, 152, 160, 168, 176, 184, and 192 hours during the hospital stay
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Pain-Related Sleep Interference Post Surgery
Time Frame: 24 hours, 48 hours, 72 hours, 96 hours 120 hours, 144 hours, 168 hours, and 192 hours post-surgery, Week 2, Week 4, Week 6/ET
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The NRS-Sleep: subject rated 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]) rating how pain has interfered with sleep during the past 24 hours.
Weekly mean scores were calculated post hospital discharge.
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24 hours, 48 hours, 72 hours, 96 hours 120 hours, 144 hours, 168 hours, and 192 hours post-surgery, Week 2, Week 4, Week 6/ET
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Change From Baseline in Visual Analogue Scale for Anxiety (VAS-Anxiety) Score Prior to Surgery
Time Frame: Day 1, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours prior to surgery
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VAS-Anxiety was administered to measure pre-operative anxiety.
Score: 0 = no anxiety to 100 = worst imaginable anxiety.
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Day 1, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours prior to surgery
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Timed Up-and-Go (TUG)
Time Frame: 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Week 2, Week 4, Week 6/ET
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TUG: time taken in seconds to rise from a standard arm chair, walk to a line on the floor 3 meters away, turn, return and sit down again.
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24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Week 2, Week 4, Week 6/ET
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Range of Motion (ROM) Assessment of the Active Flexion of the Surgical Knee
Time Frame: 24 hours, 48 hours, 72 hours, 96 hours, and 120 hours post surgery, Week 2, Week 4, Week 6/ET
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The degree of active (patient moving the knee) knee flexion and extension tolerated by each subject was recorded.
Active ROM in the sitting position was assessed with a goniometer.
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24 hours, 48 hours, 72 hours, 96 hours, and 120 hours post surgery, Week 2, Week 4, Week 6/ET
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ROM Assessment of the Passive Flexion of the Surgical Knee
Time Frame: 24 hours, 48 hours, 72 hours, 96 hours, and 120 hours post surgery, Week 2, Week 4, Week 6/ET
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The degree of passive (movement of the knee with the aid of physical therapist or designee) knee flexion and extension tolerated by each subject was recorded.
Passive ROM in the sitting position was assessed with a goniometer.
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24 hours, 48 hours, 72 hours, 96 hours, and 120 hours post surgery, Week 2, Week 4, Week 6/ET
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Time From End of Surgery to Meet Hospital Discharge Criteria
Time Frame: time from end of surgery up to 192 hours post surgery
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The analysis was performed by Kaplan-Meier method with log-rank test.
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time from end of surgery up to 192 hours post surgery
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Time From End of Surgery to Actual Discharge
Time Frame: time from end of surgery up to 192 hours post surgery
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The analysis was performed by Kaplan-Meier method with log-rank test.
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time from end of surgery up to 192 hours post surgery
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Satisfaction With Current Pain Medication Measured by the Pain Treatment Satisfaction Scale (PTSS)
Time Frame: Discharge, Week 2, Week 4, Week 6/ET
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Measure of subject satisfaction with treatment for acute or chronic pain.
Response range: 1 (strongly agree) to 5 (strongly disagree).
Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment.
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Discharge, Week 2, Week 4, Week 6/ET
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Satisfaction With Medication Characteristics Measured by the PTSS
Time Frame: Discharge, Week 2, Week 4, Week 6/ET
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Measure of subject satisfaction with treatment for acute or chronic pain.
Response range: 1 (strongly agree) to 5 (strongly disagree).
Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment.
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Discharge, Week 2, Week 4, Week 6/ET
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Satisfaction With Medication Efficacy Measured by the PTSS
Time Frame: Discharge, Week 2, Week 4, Week 6/ET
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Measure of subject satisfaction with treatment for acute or chronic pain.
Response range: 1 (strongly agree) to 5 (strongly disagree).
Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment.
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Discharge, Week 2, Week 4, Week 6/ET
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Overall Satisfaction Measured by the PTSS
Time Frame: Discharge, Week 2, Week 4, and Week 6/ET
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Measure of subject satisfaction with treatment for acute or chronic pain.
Response range: 1 (strongly agree) to 5 (strongly disagree).
Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment.
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Discharge, Week 2, Week 4, and Week 6/ET
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Overall Pain Relief Measured by the PTSS
Time Frame: Discharge, Week 2, Week 4, and Week 6/ET
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Measure of subject satisfaction with treatment for acute or chronic pain.
Response range: 1 (strongly agree) to 5 (strongly disagree).
Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment.
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Discharge, Week 2, Week 4, and Week 6/ET
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Number of Subjects With Global Evaluation of Study Medication Scores
Time Frame: Discharge, Week 2, Week 4, and Week 6/ET
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The Global Evaluation of Study Medication is a subject-administered single item instrument that records the subject's overall impression (global evaluation) of the study medication by asking the following question: how would you rate the study medication you received for pain?
The subject chooses based on a scale of 1 (poor), 2 (fair), 3 (good), or 4 (excellent).
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Discharge, Week 2, Week 4, and Week 6/ET
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Number of Subjects With Persistent Pain Based on 11-Point Verbal Rating Scale (VRS)
Time Frame: Month 3, Month 6 (phone call)
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The presence of persistent pain was evaluated on the 11-point VRS.
The subject answered the question: how much pain did you experience in the last 24 hours in your operated knee?
A zero score of VRS was the only number considered as a "no."
Any positive score (1-10) of VRS was consider as "yes."
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Month 3, Month 6 (phone call)
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Neuropathic Pain Symptom Inventory (NPSI)
Time Frame: Month 3, Month 6 (phone call)
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NPSI: subject rated questionnaire to evaluate 5 dimensions of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia). Includes 10 descriptors ranging from 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain.
Questionnaire generates a score in each relevant dimension.
Total score is calculated as the sum of scores of the 10 descriptors, range: 0-100.
Higher score indicates greater intensity of pain.
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Month 3, Month 6 (phone call)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2007
Primary Completion (Actual)
December 1, 2008
Study Completion (Actual)
December 1, 2008
Study Registration Dates
First Submitted
March 1, 2007
First Submitted That Met QC Criteria
March 1, 2007
First Posted (Estimate)
March 2, 2007
Study Record Updates
Last Update Posted (Actual)
January 22, 2021
Last Update Submitted That Met QC Criteria
January 20, 2021
Last Verified
October 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Arthritis
- Pain, Postoperative
- Osteoarthritis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Membrane Transport Modulators
- Anti-Anxiety Agents
- Anticonvulsants
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Pregabalin
Other Study ID Numbers
- A0081133
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Osteoarthritis
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Sanford HealthActive, not recruitingKnee Osteoarthritis | Hip Osteoarthritis | Shoulder Osteoarthritis | Ankle Osteoarthritis | Wrist OsteoarthritisUnited States
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University of EdinburghHospital for Special Surgery, New YorkRecruitingKnee Osteoarthritis | Hip Osteoarthritis | Shoulder OsteoarthritisUnited Kingdom
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Medical University of WarsawUnknownOsteoarthritis | Knee Osteoarthritis | Hip Osteoarthritis | Glenohumeral OsteoarthritisPoland
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Medical University of WarsawUnknownOsteoarthritis | Knee Osteoarthritis | Hip Osteoarthritis | Glenohumeral OsteoarthritisPoland
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University of California, San FranciscoStanford University; Robert Wood Johnson FoundationCompletedKnee Osteoarthritis | Hip OsteoarthritisUnited States
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University of VermontCompletedOsteoarthritis of Knee | Osteoarthritis Of HipUnited States
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Hospital for Special Surgery, New YorkRoyal Infirmary of EdinburghRecruitingKnee Osteoarthritis | Hip Osteoarthritis | Shoulder OsteoarthritisUnited States, United Kingdom
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Ottawa Hospital Research InstituteNot yet recruitingKnee Osteoarthritis | Hip Osteoarthritis
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University Hospital, LilleCompleted
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Massachusetts General HospitalNewton-Wellesley Hospital; The New England Baptist HospitalCompletedKnee Osteoarthritis | Hip OsteoarthritisUnited States
Clinical Trials on Placebo
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SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
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National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
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AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
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Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
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GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
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ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
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Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
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GlaxoSmithKlineCompletedInfections, BacterialUnited States
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West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States