Trial · NCT00487435
An Open-label Extension Study With Flexible Dosing of Extended-release (ER) Tapentadol (CG5503) to Treat Patients With Moderate to Severe Chronic Pain
NCT00487435, Phase 3, Completed, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.; results first posted 2010-07-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. An Open-label Extension Study With Flexible Dosing of Extended-release (ER) Tapentadol (CG5503) to Treat Patients With Moderate to Severe Chronic Pain. Trials, record NCT00487435. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00487435
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Open-label Extension Study With Flexible Dosing of Extended-release (ER) Tapentadol (CG5503) to Treat Patients With Moderate to Severe Chronic Pain
- NCT number
- NCT00487435
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,166 participants, actual
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Conditions
- Pain, Osteoarthritis, Low Back Pain
- Interventions
- Tapentadol (CG5503) Extended Release (ER)
- First posted
- 2007-06-18
- Last updated
- 2014-05-09
- Results first posted
- 2010-07-23
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 Subjects With Treatment-emergent Adverse Events (TEAE) | 52 weeks | The number of subjects 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, 52 weeks | The subjects 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". |
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 Subjects With Treatment-emergent Adverse Events (TEAE) | 52 weeks | Safety analysis set (All randomized subjects 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, 52 weeks | observed cases | Scores on a Scale | MEAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects With Treatment-emergent Adverse Events (TEAE) | Tapentadol (CG5503) Extended Release (ER) | 907 | participants | ||
| Change From Baseline in Average Pain Intensity Scores at Week 52 Using the Numerical Rating Scale (NRS) | Tapentadol (CG5503) Extended Release (ER) | -0.26 | Standard Deviation 2.129 | Scores on a Scale |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tapentadol (CG5503) Extended Release (ER) | 1,154 | |
| Overall Study | COMPLETED | Tapentadol (CG5503) Extended Release (ER) | 669 | |
| Overall Study | NOT COMPLETED | Tapentadol (CG5503) Extended Release (ER) | 485 |
Source ClinicalTrials.gov
Adverse events94
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) Extended Release (ER) | 135 | 1,154 | |
| other | Constipation | Gastrointestinal disorders | Tapentadol (CG5503) Extended Release (ER) | 128 | 1,154 | |
| other | Diarrhoea | Gastrointestinal disorders | Tapentadol (CG5503) Extended Release (ER) | 110 | 1,154 | |
| other | Vomiting | Gastrointestinal disorders | Tapentadol (CG5503) Extended Release (ER) | 71 | 1,154 | |
| other | Headache | Nervous system disorders | Tapentadol (CG5503) Extended Release (ER) | 151 | 1,154 | |
| other | Dizziness | Nervous system disorders | Tapentadol (CG5503) Extended Release (ER) | 98 | 1,154 | |
| other | Somnolence | Nervous system disorders | Tapentadol (CG5503) Extended Release (ER) | 61 | 1,154 | |
| other | Nasopharyngitis | Infections and infestations | Tapentadol (CG5503) Extended Release (ER) | 77 | 1,154 | |
| other | Upper respiratory tract infection | Infections and infestations | Tapentadol (CG5503) Extended Release (ER) | 71 | 1,154 | |
| other | Sinusitis | Infections and infestations | Tapentadol (CG5503) Extended Release (ER) | 63 | 1,154 |
1 to 10 of 94Source ClinicalTrials.gov
See all 94 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tapentadol (CG5503) Extended Release (ER) | ||
| Total, other adverse events | Tapentadol (CG5503) Extended Release (ER) | 659 | 1,154 |
| Total, serious adverse events | Tapentadol (CG5503) Extended Release (ER) | 84 | 1,154 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26428249 | DERIVED |
Source PubMed
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/NCT00487435
GET https://conductscience.org/api/trials/v1/NCT00487435/events?page=2