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NCT00505414 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Effectiveness and Safety of CG5503 (Tapentadol) in the Treatment of Chronic Tumor Related Pain Compared With Placebo and Morphine
A Phase 3 study, sponsored by Grünenthal.
- Terminated
- Registry status
- Phase 3
- Development phase
- 136
- Enrollment target
NCT00505414: Clinical Trial Phase 3 study, sponsored by Grünenthal.
NCT00505414 is a Phase 3 study that was terminated before completion, run by Grünenthal. The registered enrollment target is 136 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00505414, a Phase 3 study, was terminated before completion, sponsored by Grünenthal.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 136 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether CG5503 (tapentadol) is effective and safe in the treatment of chronic tumor related pain compared to placebo.
Primary Outcome
A "responder" is a participant in the study that: 1. completed 28 days of the maintenance phase 2. had a numeric rating scale score below 5 on the 11 point scale (where 0 indicates no pain and 10 indicates worst possible pain. This twice daily current pain score was averaged over Day 18 to Day 43. 3. did not use more than 30 mg of rescue medication per day on average in the 28 day (excluding the first 3 days) maintenance period (from Day 18 to Day 43). A participant that met all 3 of the above
Interventions
- DRUG Tapentadol in the Titration Phase
- DRUG Morphine in the Maintenance Phase
- DRUG Matching Placebo in the Maintenance Phase after Tapentadol in the Titration Phase
- DRUG Tapentadol in the Maintenance Phase
- DRUG Morphine in the Titration Phase
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 136 participants |
| Start Date | 2007-06 |
| Est. Completion | 2009-05 |
| Phase | Phase 3 |
Why NCT00505414 stopped before completion
NCT00505414 is an interventional study that assigns participants to a tested intervention. The registered 136 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 5 interventions - of which Tapentadol in the Titration Phase is the first listed.
NCT00505414 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00505414 about?
NCT00505414 is a clinical study titled "A Study to Evaluate the Effectiveness and Safety of CG5503 (Tapentadol) in the Treatment of Chronic Tumor Related Pain Compared With Placebo and Morphine". The purpose of this study is to determine whether CG5503 (tapentadol) is effective and safe in the treatment of chronic tumor related pain compared to placebo.
What is the current status of trial NCT00505414?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 136 participants. The study started on 2007-06. Estimated completion is 2009-05.
What interventions are being tested in trial NCT00505414?
The interventions under investigation include: Tapentadol in the Titration Phase (DRUG), Morphine in the Maintenance Phase (DRUG), Matching Placebo in the Maintenance Phase after Tapentadol in the Titration Phase (DRUG), Tapentadol in the Maintenance Phase (DRUG), Morphine in the Titration Phase (DRUG).
Who is sponsoring clinical trial NCT00505414?
This trial is sponsored by Grünenthal, which has 16 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00505414's enrollment target sits among peer trials
136 1580th of 2000 higher than 419 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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