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NCT00661466 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of A Collagen Bupivacaine Implant in Patients After Gastrointestinal Surgery
A Phase 2 study, sponsored by Innocoll.
- Terminated
- Registry status
- Phase 2
- Development phase
- 7
- Enrollment target
NCT00661466: Clinical Trial Phase 2 study, sponsored by Innocoll.
NCT00661466 is a Phase 2 study that was terminated before completion, run by Innocoll. The registered enrollment target is 7 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00661466, a Phase 2 study, was terminated before completion, sponsored by Innocoll.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 7 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether the CollaRx Bupivacaine Implant (bupivacaine sponge) is safe and effective in reducing the amount of narcotic pain medication needed to control pain during the first 24 hours after gastrointestinal (GI) surgery.
Primary Outcome
Study Terminated early due to very poor study enrollment. Target recruitment not met. Primary outcome not measured - planned statistical analyses was not performed.
Interventions
- DRUG Placebo
- DRUG Bupivacaine Collagen Sponge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2008-07-24 |
| Est. Completion | 2009-02-10 |
| Phase | Phase 2 |
Why NCT00661466 stopped before completion
NCT00661466 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00661466 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00661466 about?
NCT00661466 is a clinical study titled "Efficacy and Safety of A Collagen Bupivacaine Implant in Patients After Gastrointestinal Surgery". The purpose of this study is to determine whether the CollaRx Bupivacaine Implant (bupivacaine sponge) is safe and effective in reducing the amount of narcotic pain medication needed to control pain during the first 24 hours after gastrointestinal (GI) surgery.
What is the current status of trial NCT00661466?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 7 participants. The study started on 2008-07-24. Estimated completion is 2009-02-10.
What interventions are being tested in trial NCT00661466?
The interventions under investigation include: Placebo (DRUG), Bupivacaine Collagen Sponge (DRUG).
Who is sponsoring clinical trial NCT00661466?
This trial is sponsored by Innocoll, which has 19 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00661466's enrollment target sits among peer trials
7 1996th of 2000 higher than 5 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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