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NCT00609466 · ClinicalTrials.gov registry record · Phase 3
A Trial to Evaluate CG5503 Efficacy and Safety in Acute Pain After Bunionectomy
A Phase 3 study, sponsored by Grünenthal.
- Completed
- Registry status
- Phase 3
- Development phase
- 291
- Enrollment target
NCT00609466: Completed Phase 3 study, sponsored by Grünenthal.
NCT00609466 is a Phase 3 study that has completed, run by Grünenthal. The registered enrollment target is 291 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00609466, a Phase 3 study, has completed, sponsored by Grünenthal.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 291 participants
- Enrollment target
Study Summary
The main objective of this trial is to demonstrate the efficacy and safety of multiple-dose application of oral application of CG5503 IR 75mg compared to placebo and to assess safety and tolerability of CG5503 IR 75mg in subjects following bunionectomy. This trial was performed based on a previously performed double-blind, placebo-controlled, multiple-dose trial in the same indication investigating 3 dose strengths CG5503 IR (50, 75 and 100 mg) published under PMID: 18851776.
Primary Outcome
Pain Intensity assessed at predefined time points over a 48 hour period using an 11-point Numeric Rating Scale (NRS) where a score of zero indicates "no pain" and a score of ten indicates "pain as bad as you can imagine". Differences calculated as \[baseline-post baseline\] at each predefined time point. The theoretical maximum range of Sum of pain intensity differences (SPID48) is from -480 (indicative of an increase in pain) to 480 (indicative of a decrease in pain).
Interventions
- DRUG Placebo
- DRUG Morphine
- DRUG CG5503 IR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 291 participants |
| Start Date | 2007-09 |
| Est. Completion | 2008-02 |
| Phase | Phase 3 |
What the finished NCT00609466 record still lists
NCT00609466 is an interventional study that assigns participants to a tested intervention. The registered 291 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 (62% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00609466 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00609466 about?
NCT00609466 is a clinical study titled "A Trial to Evaluate CG5503 Efficacy and Safety in Acute Pain After Bunionectomy". The main objective of this trial is to demonstrate the efficacy and safety of multiple-dose application of oral application of CG5503 IR 75mg compared to placebo and to assess safety and tolerability of CG5503 IR 75mg in subjects following bunionectomy. This trial was performed based on a previousl...
What is the current status of trial NCT00609466?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 291 participants. The study started on 2007-09. Estimated completion is 2008-02.
What interventions are being tested in trial NCT00609466?
The interventions under investigation include: Placebo (DRUG), Morphine (DRUG), CG5503 IR (DRUG).
Who is sponsoring clinical trial NCT00609466?
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 NCT00609466's enrollment target sits among peer trials
291 1168th of 2000 higher than 830 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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