Trial · NCT00361504
A Study to Evaluate Long-Term Safety of Multiple Doses of Tapentadol (CG5503) Prolonged-Release (PR) and Oxycodone Controlled-Release (CR) in Patients With Chronic Pain
NCT00361504, Phase 3, Completed, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.; results first posted 2009-09-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Evaluate Long-Term Safety of Multiple Doses of Tapentadol (CG5503) Prolonged-Release (PR) and Oxycodone Controlled-Release (CR) in Patients With Chronic Pain. Trials, record NCT00361504. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00361504
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate Long-Term Safety of Multiple Doses of Tapentadol (CG5503) Prolonged-Release (PR) and Oxycodone Controlled-Release (CR) in Patients With Chronic Pain
- NCT number
- NCT00361504
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,123 participants, actual
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Conditions
- Osteoarthritis, Hip, Osteoarthritis, Knee, Lower Back Pain, Pain
- Interventions
- Oxycodone CR, Tapentadol (CG5503) ER
- First posted
- 2006-08-08
- Last updated
- 2014-04-29
- Results first posted
- 2009-09-04
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-emergent Adverse Events (TEAE) | 52 weeks | The number of participants who reported a TEAE during the treatment period. TEAE was defined as any adverse event that started or worsened on or after the start of the study medication and up to 3 days after the discontinuation of the study medication. |
| Secondary | Change From Baseline in Average Pain Intensity Scores at Week 52 Using the Numerical Rating Scale (NRS) | Baseline, Week 52 | The Participants indicated the average level of pain experienced, at each study visit, over the previous 24 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". Baseline was the average pain intensity scores measured prior to randomization (At Week 1). At Week 52 again the average pain intensity scores were collected and the change in scores at Week 52 from the baseline scores was considered as the change from baseline in average pain intensity scores at Week 52. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-emergent Adverse Events (TEAE) | 52 weeks | Safety analysis set (All randomized participants who took at least one dose of study medication). | Participants | NUMBER |
| SECONDARY | Change From Baseline in Average Pain Intensity Scores at Week 52 Using the Numerical Rating Scale (NRS) | Baseline, Week 52 | intent-to-treat | Scores on a Scale | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAE) | Tapentadol (CG5503) | 766 | 2.986 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAE) | Oxycodone | 202 | 2.470 | Participants | |
| Change From Baseline in Average Pain Intensity Scores at Week 52 Using the Numerical Rating Scale (NRS) | Tapentadol (CG5503) | -3.22 | Standard Deviation 2.664 | Scores on a Scale | |
| Change From Baseline in Average Pain Intensity Scores at Week 52 Using the Numerical Rating Scale (NRS) | Oxycodone | -3.14 | Standard Deviation 2.409 | Scores on a Scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tapentadol (CG5503) | 894 | |
| Overall Study | STARTED | Oxycodone | 223 | |
| Overall Study | COMPLETED | Tapentadol (CG5503) | 413 | |
| Overall Study | COMPLETED | Oxycodone | 78 | |
| Overall Study | NOT COMPLETED | Tapentadol (CG5503) | 481 | |
| Overall Study | NOT COMPLETED | Oxycodone | 145 |
Source ClinicalTrials.gov
Adverse events184
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 | Constipation | Gastrointestinal disorders | Tapentadol (CG5503) | 202 | 894 | |
| other | Constipation | Gastrointestinal disorders | Oxycodone | 86 | 223 | |
| other | Nausea | Gastrointestinal disorders | Tapentadol (CG5503) | 162 | 894 | |
| other | Nausea | Gastrointestinal disorders | Oxycodone | 74 | 223 | |
| other | Dry Mouth | Gastrointestinal disorders | Tapentadol (CG5503) | 81 | 894 | |
| other | Dry Mouth | Gastrointestinal disorders | Oxycodone | 10 | 223 | |
| other | Diarrhoea | Gastrointestinal disorders | Tapentadol (CG5503) | 71 | 894 | |
| other | Diarrhoea | Gastrointestinal disorders | Oxycodone | 12 | 223 | |
| other | Vomiting | Gastrointestinal disorders | Tapentadol (CG5503) | 63 | 894 | |
| other | Vomiting | Gastrointestinal disorders | Oxycodone | 30 | 223 |
1 to 10 of 184Source ClinicalTrials.gov
See all 184 adverse eventsAdverse event totals6
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, other adverse events | Tapentadol (CG5503) | 766 | 894 |
| Total, other adverse events | Oxycodone | 202 | 223 |
| Total, serious adverse events | Tapentadol (CG5503) | 49 | 894 |
| Total, serious adverse events | Oxycodone | 9 | 223 |
Source ClinicalTrials.gov
Papers3
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Tapentadol (CG5503) vs Oxycodone: Number of Participants With Treatment-emergent Adverse Events (TEAE) | Trial comparisons |
| Tapentadol (CG5503) vs Oxycodone: serious adverse events | Trial comparisons |
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/NCT00361504
GET https://conductscience.org/api/trials/v1/NCT00361504/events?page=2