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NCT00487435 · ClinicalTrials.gov registry record · Phase 3
An Open-label Extension Study With Flexible Dosing of Extended-release (ER) Tapentadol (CG5503) to Treat Patients With Moderate to Severe Chronic Pain
A Phase 3 study, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
- Completed
- Registry status
- Phase 3
- Development phase
- 1,166
- Enrollment target
NCT00487435: Completed Phase 3 study, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
NCT00487435 is a Phase 3 study that has completed, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.. The registered enrollment target is 1,166 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (51% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00487435, a Phase 3 study, has completed, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,166 participants
- Enrollment target
Study Summary
The purpose of the study is to assess the long-term safety profile of Tapentadol (CG5503) extended release (ER) at dosages ranging from 100 to 250 mg twice a day in treating patients with moderate to severe chronic pain over a period of 1 year. The study will also assess dosage requirements over the long term; characterize adverse events and tolerability, sleep quality, and potential symptoms of withdrawal; characterize pain intensity scores and overall impression of change; and characterize patient-related health outcomes.
Primary Outcome
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.
Interventions
- DRUG Tapentadol (CG5503) Extended Release (ER)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,166 participants |
| Start Date | 2007-06 |
| Est. Completion | 2009-06 |
| Phase | Phase 3 |
What the finished NCT00487435 record still lists
NCT00487435 is an interventional study that assigns participants to a tested intervention. Its 1,166 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (51% higher).
The record links to 0 conditions, and to 1 intervention - of which Tapentadol (CG5503) Extended Release (ER) is the first listed.
NCT00487435 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00487435 about?
NCT00487435 is a clinical study titled "An Open-label Extension Study With Flexible Dosing of Extended-release (ER) Tapentadol (CG5503) to Treat Patients With Moderate to Severe Chronic Pain". The purpose of the study is to assess the long-term safety profile of Tapentadol (CG5503) extended release (ER) at dosages ranging from 100 to 250 mg twice a day in treating patients with moderate to severe chronic pain over a period of 1 year. The study will also assess dosage requirements over the...
What is the current status of trial NCT00487435?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,166 participants. The study started on 2007-06. Estimated completion is 2009-06.
What interventions are being tested in trial NCT00487435?
The interventions under investigation include: Tapentadol (CG5503) Extended Release (ER) (DRUG).
Who is sponsoring clinical trial NCT00487435?
This trial is sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C., which has 102 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00487435's enrollment target sits among peer trials
1,166 238th of 2000 higher than 1,763 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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