Safety and Efficacy of Tapentadol Immediate Release (IR) and Oxycodone IR for Treatment of Acute Post-op Pain Following Elective Arthroscopic (Surgery Using a Thin Flexible Scope) Shoulder Surgery

November 13, 2012 updated by: Ortho-McNeil Janssen Scientific Affairs, LLC

A Randomized, Double-Blind, Multi-Center, Parallel-Group Study of Tapentadol Immediate Release (IR) Versus Oxycodone IR for the Treatment of Subjects With Acute Post-Operative Pain Following Elective Arthroscopic Shoulder Surgery

The purpose of this study is to evaluate how tapentadol immediate release (IR) and oxycodone IR treat moderate to severe post-operative pain after elective arthroscopic shoulder surgery.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a double-blind (neither the patient nor the study doctor knows the name of the assigned study drug during the study), randomized (study drug selected by chance like flipping a coin), active-comparator (patient will get active drug and there is no inactive drug), outpatient study to evaluate efficacy and how well a patient tolerates multiple doses of tapentadol immediate release (IR) versus oxycodone IR for short-term moderate to severe post-operative pain after arthroscopic (a surgical technique whereby a doctor inserts a tube-like instrument into a joint to visually inspect and repair tissues) shoulder surgery. About 370 patients will be enrolled to either receive tapentadol IR or oxycodone IR until approximately 150 patients in each treatment group are enrolled. After obtaining informed consent, patients will have screening visit procedures to determine study eligibility. Visit 1 (screening) may begin up to 21 days prior to surgery. Pre-operative assessments (e.g., physical examinations, clinical laboratory assessments) will be conducted as part of routine procedures. Patients will have a urine drug test and women who are able to have children will have a urine pregnancy test performed as part of screening prior to the study. Height and weight will be taken and a sleep questionnaire will also be completed at screening. Study staff will conduct pre-operative teaching regarding post-operative pain including: the pain intensity assessment for the study (11-point numeric rating scale where 0=no pain and 10=pain as bad as you can imagine); descriptions of mild, moderate and severe pain; instructions for dosing with study medication; and completing the study diary. Eligible patients will be post-operative men and women who have undergone elective outpatient arthroscopic shoulder surgery. Patients must have received a regional interscalene (within the scalene muscles) nerve block as the primary anesthetic (numbing medication) during the procedure and do not require intravenous (through a vein) patient-controlled analgesia post-operatively. Patients who are expected to have moderate to severe acute post-operative pain from shoulder surgery and who are appropriate candidates for outpatient pain management with an oral opioid (narcotic) pain medication will be eligible. In addition, appropriate patients are expected to require oral opioid pain medication post-operatively. Patients who continue to meet all study criteria post-operatively will be assigned to a study drug group prior to PACU discharge (PACU is considered Visit 2) and will be sent home with study medication. All patients will be prescribed a standard regimen of cold pack application to the surgical shoulder. Patients will be instructed to take the first dose of study medication as their first oral pain medication when they have at least "moderate" pain (prior to discharge or at home). Patients will be reminded about instructions on post-operative pain that were discussed during the pre-operative screening visit. Patients will also be instructed to complete a diary assessment of their current pain intensity before taking the first dose of study medication. Day 1 will be the calendar day when the patient takes the first dose of study medication. Starting on Day 1, patients will be instructed to complete assessments in paper diaries each morning and evening related to pain intensity, pain relief, and occurrences of vomiting. All patients will be contacted by telephone by a member of the study staff on the day following surgery. The staff will verify that the first dose of study medication was taken and the baseline pain intensity assessment was recorded. All patients will receive a second telephone call from the study staff on Day 3. During this telephone call, site personnel will inquire about the patient's overall status and will reinforce diary compliance. If the study staff determines it is necessary, the patient will be required to return to the study site for an unscheduled visit. Patients may take up to 2 pills (any form) of acetaminophen for pain other than post-operative shoulder pain (e.g., headache, back pain) once per day only for up to a total of 2 days during the study. Patients who take up to 325 mg/day aspirin as prevention for a heart condition will be permitted to enter the study and continue on study medication provided they are on a stable dose for at least 1 month prior to study entry and plan to continue the same dose during the study. Patients who complete the study will return to the study site for a final visit (Visit 3) on Day 7. Patients who discontinue early for any reason (i.e., lack of efficacy, adverse events, patient's choice) should contact the study staff before taking supplemental pain medication and schedule his/her final visit. Patients will complete a final assessment of pain intensity and pain relief. In addition, all patients will complete a sleep questionnaire, a Patient Global Impression of Change and an assessment of satisfaction with treatment. The study doctor will complete a Clinician Global Impression of Change and will record any medical resource utilization noted in the office charts (e.g., unplanned calls from the subject, unscheduled office visits, emergency room visits). Vital signs will be obtained and study medication will be collected and counted. Patients will have adverse events assessed and any changes in concomitant medications (other medications taken at the same time as the study medication) recorded. All patients will have post-study medication prescribed at the study doctor's discretion. A patient may elect to take supplemental pain medication to treat their post-operative shoulder pain at any time during the study; however, patients who take supplemental pain medication will be considered discontinued from the study. Patients will be assigned by chance equally (1:1) in a blinded (neither the patient or study doctor knows) fashion to get tapentadol immediate release (IR) 50 or 100 mg vs oxycodone IR 5 or 10 mg, every 4-6 hours as needed. Treatment is up to 7 days starting on Day 1 with one capsule of study medication. A "re-dose" is permitted and may be administered as soon as one hour after the first dose only. For subsequent doses, patients may take one or two capsules every 4 to 6 hours as needed.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
382

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy on the basis of medical history and vital signs and meeting the American Society of Anesthesiology (ASA) physical status I, II, or III
  • completed screening procedures and have undergone one of the following elective outpatient arthroscopic surgical procedures: rotator cuff repair, labral tear repair, Bankart repair
  • an arthroscopic mini-open rotator cuff repair
  • (an arthroscopic distal clavicle resection performed in conjunction with a rotator cuff, labral tear or Bankart repair is also permitted)
  • received anesthesia administered to the shoulder by interscalene nerve block
  • receive study medication as the first oral analgesic medication following the orthopedic surgical procedure and expected to have moderate to severe pain requiring oral opioids for at least 3 days after surgery.

Exclusion Criteria:

  • Patients whose post-operative pain would require non opioid analgesia as standard of care
  • received a non-allowed procedure
  • received intraoperative or post-operative anesthesia and/or analgesic medications which are expected to provide post-operative analgesia for >24 hours after discharge from the PACU (recovery room)
  • received intraoperatively >200 mg fentanyl or the morphine equivalent of another opioid (for the total procedure) or potent inhaled anesthesia (e.g., sevoflurane, isoflurane)
  • received IV PCA analgesia (intravenous pump the patient controls) in the PACU or a PACU stay >8 hours
  • expected to require inpatient treatment in a hospital or rehabilitation unit post operatively
  • anticipate any surgical procedure(s) within 7 days after the initial shoulder surgery
  • have significant nausea and/or vomiting at the time of randomization (patients may receive an anti-emetic prior to or during surgery)
  • received any of the following: long-acting or controlled-release opioids within 1-month prior to randomization
  • immediate release CII opioid formulations (e.g., Opana IR, Percocet, Percodan, oxycodone IR, Dilaudid) for >5 days total within 1 month before, and within 24 hours of, randomization
  • intra-articular (within a joint) or systemic steroids (except inhalers and topical steroids), within 1 month before randomization (exception, patients on a stable dose of chronic steroids for a minimum of 3 months, for a condition other than the shoulder pain)
  • use of non-steroidal anti-inflammatory drugs (NSAIDs) within 24-hours of randomization
  • have taken any CIII opioid formulation (e.g., Tylenol with Codeine) >3 days/week in the 1-month prior to randomization
  • treated with anticonvulsants, monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants (TCAs), neuroleptics, or serotonin norepinephrine reuptake inhibitors (SNRIs) within 2 weeks before randomization
  • positive urine drug screen (cocaine, methadone, amphetamines, cannabinoids, opiates, benzodiazepines, barbiturates, and oxycodone)
  • have an active systemic or local infection
  • significant co-existing autoimmune inflammatory conditions
  • history of seizure disorder or epilepsy
  • presence of any of the following: mild or moderate traumatic brain injury, stroke, transient ischemic attack, or brain neoplasm within 1 year of screening
  • severe traumatic brain injury, episode(s) of unconsciousness of more than 24 hours duration, or post-traumatic amnesia of more than 24 hours duration within 15 years of screening
  • known history of alcohol or drug abuse in the study doctor's judgment based on medical history
  • known or suspected to be opioid tolerant or dependent
  • known history of laboratory values reflecting severe kidney disease, known history of moderately or severely impaired liver function
  • history of allergy to, or hypersensitivity to tapentadol, oxycodone, or other components of the medication
  • history (within the past 6 months) of a major psychiatric disorder
  • history of suicidal ideation or suicidal attempts within the past 2 years
  • currently involved in litigation regarding their shoulder injury, have a disability claim or patients who are receiving Worker's Compensation due to their shoulder injury or are being evaluated to receive disability or Worker's Compensation

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
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: 001
Tapentadol IR First dose: one 50 mg capsule (a re-dose of 50 mg is permitted as soon as one hour after the first dose on Day 1 if needed) Subsequent doses: one or two capsules (50 mg or 100 mg) every 4 to 6 hours as needed
Drug: Tapentadol IR
First dose: one 50 mg capsule (a re-dose of 50 mg is permitted as soon as one hour after the first dose on Day 1, if needed) Subsequent doses: one or two capsules (50 mg or 100 mg) every 4 to 6 hours as needed
ACTIVE_COMPARATOR: 002
Oxycodone IR First dose: one 5 mg capsule (a re-dose of 5 mg is permitted as soon as one hour after the first dose on Day 1 if needed Subsequent doses: one or two capsules (5 mg or 10 mg) every 4 to 6 hours as needed
Drug: Oxycodone IR
First dose: one 5 mg capsule (a re-dose of 5 mg is permitted as soon as one hour after the first dose on Day 1, if needed Subsequent doses: one or two capsules (5 mg or 10 mg) every 4 to 6 hours as needed

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Summary and Analysis of Sum of Pain Intensity Difference (SPID) (With Imputation) Over 3 Days (72 Hours)
Time Frame: 3 Days (72 hours)
Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID72 was calculated as the time-weighted Sum of PID scores over 72 hours. The range of SPID72 is from -720 to 720. The higher value in SPID indicates greater pain relief.
3 Days (72 hours)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Summary of Kaplan-Meier Estimates for Time to Achieve 50% Reduction in Pain Intensity From Baseline
Time Frame: 7 Days
From date of first administration of study medication to time to achieve adequate 50% reduction in pain intensity from baseline score. Censored observations included subjects who completed or discontinued from the study without a 50% reduction in pain intensity from baseline score. If a subject discontinued due to lack of efficacy (including rescue medication), the subject was censored on Day 7, 12 PM.
7 Days
Summary of Kaplan-Meier Estimates for Time to Achieve 30% Reduction in Pain Intensity From Baseline
Time Frame: 7 Days
From date of first administration of study medication to time to achieve adequate 30% reduction in pain intensity from baseline score. Censored observations included subjects who completed or discontinued from the study without a 30% reduction in pain intensity from baseline score. If a subject discontinued due to lack of efficacy (including rescue medication), the subject was censored on Day 7, 12 PM.
7 Days
Summary of 30% Responder Rate (With Imputation) on Day 3
Time Frame: Day 3
The 30% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 30% from baseline in pain intensity at Day 3 (average of Day 3 PM and Day 4 AM). If a subject has only the Day 3 PM value or Day 4 AM value, then response rate will be based on the non-missing value. If a subject withdraws or uses rescue medication before Day 3 PM then Baseline Observation Carried Forward (BOCF) will be imputed. Last Observation Carried Forward (LOCF) may be used if no value afterward.
Day 3
Summary of 30% Responder Rate (With Imputation) on Day 7
Time Frame: Day 7
The 30% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 30% from baseline in pain intensity at Day 7 (average of Day 6 PM and Day 7 AM). If a subject has only the Day 6 PM value or Day 7 AM value, then response rate will be based on the non-missing value. If a subject withdraws or uses rescue medication before Day 6 PM then BOCF will be imputed. LOCF may be used if no value afterward.
Day 7
Summary of 50% Responder Rate (With Imputation) on Day 3
Time Frame: Day 3
The 50% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 50% from baseline in pain intensity at Day 3 (average of Day 3 PM and Day 4 AM). If a subject has only the Day 3 PM value or Day 4 AM value, then response rate will be based on the non-missing value. If a subject withdraws or uses rescue medication before Day 3 PM then BOCF will be imputed. LOCF may be used if no value afterward.
Day 3
Summary of 50% Responder Rate (With Imputation) on Day 7
Time Frame: Day 7
The 50% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 50% from baseline in pain intensity at Day 7 (average of Day 6 PM and Day 7 AM). If a subject has only the Day 6 PM value or Day 7 AM value, then response rate will be based on the non-missing value. If a subject withdraws or uses rescue medication before Day 6 PM then BOCF will be imputed. LOCF may be used if no value afterward.
Day 7
Summary and Analysis of Sum of Pain Intensity Difference (SPID) (With Imputation) Over 2 Days (48 Hours)
Time Frame: 2 Days (48 hours)
Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID48 was calculated as the time-weighted Sum of PID scores over 48 hours. The range of SPID48 is from -480 to 480. The higher value in SPID indicates greater pain relief.
2 Days (48 hours)
Summary and Analysis of Sum of Pain Intensity Difference (SPID) (With Imputation) Over 7 Days
Time Frame: 7 Days
Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID over 7 Days was calculated as the time-weighted Sum of PID scores up to Day 7, 8 AM. The range is from -1440 to 1440. The higher value in SPID indicates greater pain relief.
7 Days
Summary and Analysis of Total Pain Relief (TOTPAR) (With Imputation) Over 2 Days (48 Hours)
Time Frame: 2 Days (48 hours)
Pain Relief was defined as a 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Total Pain Relief (TOTPAR) was calculated as the time-weighted sum over all pain relief up to hour 48. The range of TOTPAR over 2 days is from 0 to 192. A higher value in TOTPAR indicated greater pain relief.
2 Days (48 hours)
Summary and Analysis of Total Pain Relief (TOTPAR) (With Imputation) Over 3 Days (72hours)
Time Frame: 3 Days (72hours)
Pain Relief was defined as a 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Total Pain Relief (TOTPAR) was calculated as the time-weighted sum over all pain relief up to hour 72. The range of TOTPAR over 3 days is from 0 to 288. A higher value in TOTPAR indicated greater pain relief.
3 Days (72hours)
Summary and Analysis of Total Pain Relief (TOTPAR) (With Imputation) Over 7 Days
Time Frame: 7 Days
Pain Relief was defined as a 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Total Pain Relief (TOTPAR) was calculated as the time-weighted sum over all pain relief up to Day 7, 8 AM. The range of TOTPAR over 7 days is from 0 to 576. A higher value in TOTPAR indicated greater pain relief.
7 Days
Summary and Analysis of the Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) (With Imputation) Over 2 Days (48 Hours)
Time Frame: 2 Days (48 hours)
The Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) was derived from Sum of TOTPAR and SPID. The range of SPRID over 2 days is from -480 to 672. A higher value in SPRID indicated greater pain relief.
2 Days (48 hours)
Summary and Analysis of the Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) (With Imputation) Over 3 Days (72 Hours)
Time Frame: 3 Days (72hours)
The Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) was derived from Sum of TOTPAR and SPID. The range of SPRID over 3 days is from -720 to 1008. A higher value in SPRID indicated greater pain relief.
3 Days (72hours)
Summary and Analysis of the Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) (With Imputation) Over 7 Days
Time Frame: 7 Days
The Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) was derived from Sum of TOTPAR and SPID. The range of SPRID over 7 days is from -1440 to 2016. A higher value in SPRID indicated greater pain relief.
7 Days
Subject Satisfaction With Treatment
Time Frame: 7 Days
Treatment satisfaction was measured using a 7-point scale where 1 = very satisfied and 7 = very dissatisfied
7 Days
Patient Global Impression of Change (PGIC) at End of Study
Time Frame: 7 Days
Patient Global Impression of Change (PGIC) was defined as the 7-point numeric scale, where 1=very much improved to 7=very much worse.
7 Days
Clinician Global Impression of Change (CGIC) at End of Study
Time Frame: 7 Days
Clinician Global Impression of Change (CGIC) was defined as the 7-point numeric scale, where 1=very much improved to 7=very much worse.
7 Days
Summary of Medical Resource Utilization - Number of Calls by the Subject to Study Site Personnel
Time Frame: 7 Days
Information associated with contacts with a healthcare professional was collected by the investigator and study staff for all subjects throughout the study.
7 Days
Summary of Medical Resource Utilization - Number of Other Types of Contacts With Healthcare Professionals
Time Frame: 7 Days
Information associated with contacts with a healthcare professional was collected by the investigator and study staff for all subjects throughout the study.
7 Days
Sleep Quality: Trouble Falling Asleep? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)
Time Frame: Baseline and 7 Days
Over the past 7 days patients reported "trouble falling asleep" by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7).
Baseline and 7 Days
Sleep Quality: Trouble Falling Asleep? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)
Time Frame: Baseline and 7 Days
Over the past 7 days patients reported "trouble falling asleep" by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7).
Baseline and 7 Days
Sleep Quality: Wake up Several Times During Night? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)
Time Frame: Baseline and 7 Days
Over the past 7 days patients reported "Wake up several times during night" by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7).
Baseline and 7 Days
Sleep Quality: Wake up Several Times During Night? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)
Time Frame: Baseline and 7 Days
Over the past 7 days patients reported "Wake up several times during night" by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7).
Baseline and 7 Days
Sleep Quality: Trouble Staying Asleep? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)
Time Frame: Baseline and 7 Days
Over the past 7 days patients reported "Trouble staying asleep" by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7).
Baseline and 7 Days
Sleep Quality: Trouble Staying Asleep? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)
Time Frame: Baseline and 7 Days
Over the past 7 days patients reported "Trouble staying asleep" by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7).
Baseline and 7 Days
Sleep Quality: Pain Interferes With Sleep? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)
Time Frame: Baseline and 7 Days
Over the past 7 days patients reported "Pain interferes with sleep" by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7).
Baseline and 7 Days
Sleep Quality: Pain Interferes With Sleep? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)
Time Frame: Baseline and 7 Days
Over the past 7 days patients reported "Pain interferes with sleep" by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7).
Baseline and 7 Days
Sleep Quality: Wake up Feeling Tired and Worn Out? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)
Time Frame: Baseline and 7 Days
Over the past 7 days patients reported "Wake up feeling tired and worn out" by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7).
Baseline and 7 Days
Sleep Quality: Wake up Feeling Tired and Worn Out? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)
Time Frame: Baseline and 7 Days
Over the past 7 days patients reported "Wake up feeling tired and worn out" by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7).
Baseline and 7 Days
Sleep Quality: Feeling Alert During Daytime Hours? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)
Time Frame: Baseline and 7 Days
Over the past 7 days patients reported "Feeling alert during daytime hours" by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7).
Baseline and 7 Days
Sleep Quality: Feeling Alert During Daytime Hours? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)
Time Frame: Baseline and 7 Days
Over the past 7 days patients reported "Feeling alert during daytime hours" by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7).
Baseline and 7 Days
Sleep Quality: Feeling Well Rested? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)
Time Frame: Baseline and 7 Days
Over the past 7 days patients reported "Feeling well rested" by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7).
Baseline and 7 Days
Sleep Quality: Feeling Well Rested? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)
Time Frame: Baseline and 7 Days
Over the past 7 days patients reported "Feeling well rested" by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7).
Baseline and 7 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ortho-McNeil Janssen Scientific Affairs, LLC

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Grünenthal GmbH

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.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2008

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2010

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 23, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 23, 2008

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 25, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 20, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2012

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Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR015040
  • R331333PAI3022 (OTHER: Ortho-McNeil Janssen Scientific Affairs, LLC)
  • KF5503/49 (OTHER: Grunenthal GmbH)

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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