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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00487435
The ClinicalTrials.gov registry entry for NCT00487435 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,166 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johnson & Johnson Pharmaceutical Research & Development, L.L.C., which has 102 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Tapentadol (CG5503) Extended Release (ER) is the first listed.
NCT00487435 reports 0 study locations.
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.
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