Trial · NCT00421928
Tapentadol (CG5503)
NCT00421928, Phase 3, Completed, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.; results first posted 2010-04-23
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Tapentadol (CG5503). Trials, record NCT00421928. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00421928
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Tapentadol (CG5503)
- NCT number
- NCT00421928
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,030 participants, actual
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Conditions
- Osteoarthritis, Knee, Pain
- Interventions
- oxycodone, placebo, tapentadol (CG5503)
- First posted
- 2007-01-15
- Last updated
- 2012-04-18
- Results first posted
- 2010-04-23
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline of the Average Pain Intensity Based on an 11-point Numerical Rating Scale(NRS) Over the Last Week of the Maintenance Period at Week 12. | Baseline and 12 weeks (Primary endpoint is the average pain intensity score during the last week of the maintenance period). | For this twice daily pain assessment, the subjects were to indicate the level of pain experienced over the previous 12 hours on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine". |
| Secondary | Change From Baseline in Western Ontario McMaster Questionnaire (WOMAC) Assessing Pain, Disability and Joint Stiffness of the Knee Over the Last Week of the Maintenance Period at Week 12 | Baseline and 12 week endpoint | Change from baseline to Week 12 of WOMAC Global Score: WOMAC is measure with a Likert ordinal scale from 0-4 with lower scores indicating lower levels of symptoms or physical disability |
| Secondary | Change From Baseline in Sleep Latency Time in Hours Over the Last Week of the Maintenance Period at Week 12. | Baseline and 12 week endpoint | A Sleep Questionniare addressed the following question: "How long after bedtime/lights out did you fall asleep last night (hours)?" 12 week endpoint-mean changes from baseline at endpoint for sleep latency. Decrease in time(hours) indicates improvement. |
| Secondary | Percentage of Patients Who Reported Very Much Improved or Much Improved From Baseline in Patient Global Impression of Change Over the Last Week of the Maintenance Period at Week 12 | Baseline and 12 week endpoint | Ordinal measure indicating change from start of treatment (on a scale of 7 = Very much worse to 1 = Very much improved) |
| Secondary | Distribution of Time to Treatment Discontinuation Due to Lack of Efficacy | Baseline to 12 weeks | The median time to treatment discontinuation due to lack of efficacy from baseline to endpoint |
| Secondary | Change From Baseline in EuroQol-5 (EQ-5D) Health Status Index to Week 12 | Baseline and 12 week endpoint | Change from baseline to end point in EuroQol-5 (EQ-5D) Dimension Questionnaire. A higher score indicates an improvement in health in the Health Status Index. The EQ-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "full health" and 0 representing dead |
| Secondary | Change From Baseline in Responder Analysis 50% Improvement to Week 12 | Baseline and Week 12 | Defined by the percentage of subjects achieving at least 50% improvement from baseline in the primary endpoint based on the 11-point NRS at week 12. For this twice daily pain assessment, the subjects were to indicate the level of pain experienced over the previous 12 hours on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine". |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline of the Average Pain Intensity Based on an 11-point Numerical Rating Scale(NRS) Over the Last Week of the Maintenance Period at Week 12. | Baseline and 12 weeks (Primary endpoint is the average pain intensity score during the last week of the maintenance period). | Intent-to-treat (ITT) population. Last observation carried forward (LOCF) was used to impute pain score after discontinuation | Scores on a scale | MEAN |
| SECONDARY | Change From Baseline in Western Ontario McMaster Questionnaire (WOMAC) Assessing Pain, Disability and Joint Stiffness of the Knee Over the Last Week of the Maintenance Period at Week 12 | Baseline and 12 week endpoint | Intent To Treat (ITT), observed cases analysis conducted, no imputation performed. | Scores on a scale | MEAN |
| SECONDARY | Change From Baseline in Sleep Latency Time in Hours Over the Last Week of the Maintenance Period at Week 12. | Baseline and 12 week endpoint | ITT | Hours | MEAN |
| SECONDARY | Percentage of Patients Who Reported Very Much Improved or Much Improved From Baseline in Patient Global Impression of Change Over the Last Week of the Maintenance Period at Week 12 | Baseline and 12 week endpoint | ITT | percentage of participants | NUMBER |
| SECONDARY | Distribution of Time to Treatment Discontinuation Due to Lack of Efficacy | Baseline to 12 weeks | ITT: The results for median and interquartile ranges were not estimable because insufficient number of subjects discontinued due to lack of efficacy to estimate the values. | median time | NUMBER |
| SECONDARY | Change From Baseline in EuroQol-5 (EQ-5D) Health Status Index to Week 12 | Baseline and 12 week endpoint | ITT | scores on a scale | MEAN |
| SECONDARY | Change From Baseline in Responder Analysis 50% Improvement to Week 12 | Baseline and Week 12 | ITT. Subjects who discontinued from the study were considered non-responders. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline of the Average Pain Intensity Based on an 11-point Numerical Rating Scale(NRS) Over the Last Week of the Maintenance Period at Week 12. | Tapentadol (CG5503) | -3.0 | Standard Deviation 2.39 | Scores on a scale | |
| Change From Baseline of the Average Pain Intensity Based on an 11-point Numerical Rating Scale(NRS) Over the Last Week of the Maintenance Period at Week 12. | Oxycodone | -2.6 | Standard Deviation 2.38 | Scores on a scale | |
| Change From Baseline of the Average Pain Intensity Based on an 11-point Numerical Rating Scale(NRS) Over the Last Week of the Maintenance Period at Week 12. | Placebo | -2.2 | Standard Deviation 2.54 | Scores on a scale | |
| Change From Baseline in Western Ontario McMaster Questionnaire (WOMAC) Assessing Pain, Disability and Joint Stiffness of the Knee Over the Last Week of the Maintenance Period at Week 12 | Tapentadol (CG5503) | -1.2 | Standard Deviation 0.82 | Scores on a scale | |
| Change From Baseline in Western Ontario McMaster Questionnaire (WOMAC) Assessing Pain, Disability and Joint Stiffness of the Knee Over the Last Week of the Maintenance Period at Week 12 | Oxycodone | -1.1 | Standard Deviation 0.87 | Scores on a scale | |
| Change From Baseline in Western Ontario McMaster Questionnaire (WOMAC) Assessing Pain, Disability and Joint Stiffness of the Knee Over the Last Week of the Maintenance Period at Week 12 | Placebo | -0.9 | Standard Deviation 0.84 | Scores on a scale | |
| Change From Baseline in Sleep Latency Time in Hours Over the Last Week of the Maintenance Period at Week 12. | Tapentadol (CG5503) | 0.2 | Standard Deviation 2.8 | Hours | |
| Change From Baseline in Sleep Latency Time in Hours Over the Last Week of the Maintenance Period at Week 12. | Oxycodone | 0.1 | Standard Deviation 1.81 | Hours | |
| Change From Baseline in Sleep Latency Time in Hours Over the Last Week of the Maintenance Period at Week 12. | Placebo | 0.3 | Standard Deviation 2.72 | Hours | |
| Percentage of Patients Who Reported Very Much Improved or Much Improved From Baseline in Patient Global Impression of Change Over the Last Week of the Maintenance Period at Week 12 | Tapentadol (CG5503) | 51.1 | percentage of participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tapentadol (CG5503) | 344 | |
| Overall Study | STARTED | Oxycodone | 342 | |
| Overall Study | STARTED | Placebo | 337 | |
| Overall Study | COMPLETED | Tapentadol (CG5503) | 181 | |
| Overall Study | COMPLETED | Oxycodone | 118 | |
| Overall Study | COMPLETED | Placebo | 203 | |
| Overall Study | NOT COMPLETED | Tapentadol (CG5503) | 163 | |
| Overall Study | NOT COMPLETED | Oxycodone | 224 | |
| Overall Study | NOT COMPLETED | Placebo | 134 |
Source ClinicalTrials.gov
Adverse events99
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Tapentadol (CG5503) | 74 | 344 | |
| other | Nausea | Gastrointestinal disorders | Oxycodone | 125 | 342 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 23 | 337 | |
| other | Constipation | Gastrointestinal disorders | Tapentadol (CG5503) | 65 | 344 | |
| other | Constipation | Gastrointestinal disorders | Oxycodone | 126 | 342 | |
| other | Constipation | Gastrointestinal disorders | Placebo | 22 | 337 | |
| other | Dry Mouth | Gastrointestinal disorders | Tapentadol (CG5503) | 22 | 344 | |
| other | Dry Mouth | Gastrointestinal disorders | Oxycodone | 15 | 342 | |
| other | Dry Mouth | Gastrointestinal disorders | Placebo | 8 | 337 | |
| other | Vomiting | Gastrointestinal disorders | Tapentadol (CG5503) | 18 | 344 |
1 to 10 of 99Source ClinicalTrials.gov
See all 99 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tapentadol (CG5503) | ||
| Total, all-cause mortality | Oxycodone | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Tapentadol (CG5503) | 200 | 344 |
| Total, other adverse events | Oxycodone | 269 | 342 |
| Total, other adverse events | Placebo | 134 | 337 |
| Total, serious adverse events | Tapentadol (CG5503) | 4 | 344 |
| Total, serious adverse events | Oxycodone | 10 | 342 |
| Total, serious adverse events | Placebo | 6 | 337 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00421928
GET https://conductscience.org/api/trials/v1/NCT00421928/events?page=2