- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00766675
An Efficacy Study of Combination of Tramadol and Acetaminophen Tablets in the Treatment of Participants With Fibromyalgia Pain
May 29, 2013 updated by: Johnson & Johnson Taiwan Ltd
Ultracet (Tramadol HCL [37.5 mg]/Acetaminophen [325 mg]) Combination Tablets in the Treatment of the Pain of Fibromyalgia
The purpose of this study is to evaluate the analgesic effect of combination of tramadol hydrochloride and acetaminophen in participants for treatment of fibromyalgia pain (chronic widespread pain and presence of tender points).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is an open-label (all people know the identity of the intervention) and multi-center (conducted in more than one center) study of combination of tramadol hydrochloride and acetaminophen in treatment of participants with pain of fibromyalgia.
The duration of this study will be 56 days per participant.
The study consists of 2 parts: Screening (that is, 3 weeks before study commences on Day 1) and Treatment (that is, up to Day 56).
All the eligible participants will receive oral tablet for combination of tramadol hydrochloride and acetaminophen.
Rescue medication (a medication intended to relieve symptoms immediately) of tylenol (500 milligram, up to 6 oral tablets daily) will be permitted throughout the study duration.
Efficacy of the participants will primarily be evaluated by Pain Visual Analog Scale.
Participants' safety will be monitored throughout the study.
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Phase 4
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
20 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Participants must meet the American College of Rheumatology 1990 criteria for the classification of fibromyalgia (that are, Participants must have had widespread pain [pain in three quadrants and in the axial skeleton] for at least three months and pain on digital palpation in 11 or more of the 18 tender-point sites
- Female participants must not be pregnant, breast feeding or postmenopausal for at least one year
- Participant must be able to take oral medication
- Participants must have completed the Screening or wash-out procedures and have a visual analog scale score greater than or equal to 40 milliliter
- Fail to non-opioid analgesics
Exclusion Criteria:
- Participants who previously failed tramadol hydrochloride therapy or those who discontinued tramadol hydrochloride due to adverse events
- Participants diagnosed with either any active connective tissue or musculo-skeletal diseases, or malignancy or history of malignancy within past 5 years, or painful, symptomatic osteoarthritis, or regional periarticular pain syndromes, spondyloarthropathy and major endocrine disease
- Participants who currently have more severe pain than the pain of fibromyalgia
- Participants who have taken antidepressants, cyclobenzaprine or anti-epileptic drugs for pain within three weeks of the Treatment Phase
- Participants who have taken short-acting analgesics, topical medications and anesthetics and/or muscle relaxants for a period of less than 21 days of the given medication prior to the Treatment Phase
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: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Tramadol hydrochloride/acetaminophen
Tramadol hydrochloride/acetaminophen oral tablet will be administered as 37.5 /325 milligram respectively once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
|
Tramadol hydrochloride oral tablet will be administered at a dose of 37.5 milligram as, once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
Acetaminophen oral tablet will be administered at a dose of 325 milligram as, once daily for Day 1-3, twice daily for Day 4-6 and thrice daily for Day 7-56.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Visual Analog Scale Score at Day 14
Time Frame: Day 14
|
Pain visual analog scale was used to assess the amount of pain recently experienced (within the last 48 hours) by marking a slash through the line of a 100 millimeter (mm) scale measuring pain from "no pain (0 mm)" to "worst possible pain (100 mm)".
|
Day 14
|
Pain Visual Analog Scale Score at Day 28
Time Frame: Day 28
|
Pain visual analog scale was used to assess the amount of pain recently experienced (within the last 48 hours) by marking a slash through the line of a 100 millimeter (mm) scale measuring pain from "no pain (0 mm)" to "worst possible pain (100 mm)".
|
Day 28
|
Pain Visual Analog Scale Score at Day 56
Time Frame: Day 56
|
Pain visual analog scale was used to assess the amount of pain recently experienced (within the last 48 hours) by marking a slash through the line of a 100 millimeter (mm) scale measuring pain from "no pain (0 mm)" to "worst possible pain (100 mm)".
|
Day 56
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Categorical Scores on Pain Relief Rating Scale
Time Frame: Day 14, 28 and 56
|
Pain Relief Rating Scale was used to measure the amount of pain relief experienced (on average) relative to the no-medication Screening or wash-out phase using a 6-point Likert scale ranging from (-) 1 to 4 and rated as (-) 1=worse, 0=None, 1=Slight, 2=moderate,3=a lot and 4=complete.
|
Day 14, 28 and 56
|
Tender-Point Evaluation/ Myalgic Score
Time Frame: Baseline and Day 56
|
Eighteen tender-point sites were evaluated by digital palpation for pain by the same Investigator at each site.
The Investigator rated the participant's response to digital palpation on a scale from 0 (no pain [participant did not have a tender point]) to 3 (participant withdrawn or flinched).
Total myalgic score was the sum of tender-point pain ratings.The total tender-Point score ranges from 0 to 18, and the total myalgic score ranges from 0 to 54.
Higher score indicates worsening.
|
Baseline and Day 56
|
Sleep Questionnaire: Number of Hours to Fall Asleep and Participant Slept
Time Frame: Baseline and Day 56
|
The patient assessment sleep questionnaire consisted of 12-Questions (Q) to evaluate the participant's sleep habits out of which Q1 was "How long did it usually take for participant to fall asleep during the past 4 weeks" and Q2 was "On the average, how many hours did participant sleep each night during the past 4 weeks".
|
Baseline and Day 56
|
Participant Assessment Sleep Questionnaire Score
Time Frame: Baseline and Day 56
|
Sleep questionnaire consisted of 12-Questions (Q), Q3-Q12 were related to "How often during past 4 weeks did participant felt" and are as: Q3: sleep not quiet, Q4: get enough sleep to feel rested upon waking in morning, Q5: awaken short of breath or with headache, Q6: feel drowsy or sleepy, Q7: have trouble falling asleep, Q8: awaken during sleep time and have trouble falling asleep again, Q9: trouble staying awake during day, Q10: snore, Q11: take naps during day, Q12: get amount of sleep needed.
Score ranged from 1= all the time to 6 = none of the time, higher score indicates improvement.
|
Baseline and Day 56
|
Total Fibromyalgia Impact Questionnaire (FIQ) Score
Time Frame: Baseline and Day 56
|
The FIQ was 19-item questionnaire which measured participant status, progress and outcomes.
First 10 items made up of a physical functioning scale, ranging from 0 (always) to 3 (never).
Items 11 and 12 asked participants to mark the number of days they felt well (0-7 days) and missed work (0-5 days).
Items 13-19 were measured using 10 centimeter (cm) visual analog scale, score ranging from 0 cm (no) to 10 cm (very).
Total FIQ score ranged from 0 -100 which was calculated as sum of final scores for item 1-10, 11 and 12, and individual score for item 13-19, and higher score indicates worsening.
|
Baseline and Day 56
|
Number of Participants With Physician Global Assessment
Time Frame: Day 14, 28 and 56
|
The treating physician rated the participant's condition on Day 1 before the start of treatment and each return visit.
The assessment included how the drug controlled the pain (Question 1 [Q1]), adverse event (Question 2 [Q2]), and overall evaluation (Question 3 [Q3]), and participant's condition was indicated as very good, good, moderate, poor and very poor.
|
Day 14, 28 and 56
|
Number of Participants With Subject's Global Assessment
Time Frame: Day 14, 28 and 56
|
Participants indicated their condition on Day 1 before the start of treatment and each return visit.
The assessment included how the drug controlled the pain (Question 1 [Q1]), adverse event (Question 2 [Q2]), and overall evaluation (Question 3 [Q3]), and participants indicated their condition as very good, good, moderate, poor and very poor.
|
Day 14, 28 and 56
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
October 1, 2008
Primary Completion (ACTUAL)
March 1, 2009
Study Completion (ACTUAL)
April 1, 2009
Study Registration Dates
First Submitted
October 3, 2008
First Submitted That Met QC Criteria
October 3, 2008
First Posted (ESTIMATE)
October 6, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
July 3, 2013
Last Update Submitted That Met QC Criteria
May 29, 2013
Last Verified
May 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Muscular Diseases
- Neuromuscular Diseases
- Fibromyalgia
- Myofascial Pain Syndromes
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Antipyretics
- Analgesics, Opioid
- Narcotics
- Acetaminophen
- Tramadol
Other Study ID Numbers
- CR015319
- TRAMMAPPAI4033
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.
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