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NCT01220024 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of CollaRx® Bupivacaine Implant in Men After Open Laparotomy Herniorrhaphy
A Phase 2 study, sponsored by Innocoll.
- Completed
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
NCT01220024: Completed Phase 2 study, sponsored by Innocoll.
NCT01220024 is a Phase 2 study that has completed, run by Innocoll. The registered enrollment target is 50 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01220024, a Phase 2 study, has completed, sponsored by Innocoll.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
Study Summary
This study will assess pain intensity for the first 72 hrs after after aggravated movement (cough)following open laparotomy inguinal herniorrhaphy in patient who receive either the CollaRx Bupivacaine implant or a plain collagen sponge.
Primary Outcome
The primary efficacy variable was SPI defined as area under the curve (AUC) of 100-mm VAS pain intensity scores after aggravated movement (cough) from 1 to 72 hours after surgery. Minimum score is "0". Maximum score is 7200. This represents the AUC (Area Under the Curve) of the pain intensities when calculated with the trapezoidal rule. A lower score means a better outcome or less pain reported.
Interventions
- DRUG Bupivacaine Collagen Sponge
- DRUG Placebo collagen Sponge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2010-12-02 |
| Est. Completion | 2011-05-18 |
| Phase | Phase 2 |
What the finished NCT01220024 record still lists
NCT01220024 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 2 interventions - of which Bupivacaine Collagen Sponge is the first listed.
NCT01220024 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01220024 about?
NCT01220024 is a clinical study titled "Safety and Efficacy of CollaRx® Bupivacaine Implant in Men After Open Laparotomy Herniorrhaphy". This study will assess pain intensity for the first 72 hrs after after aggravated movement (cough)following open laparotomy inguinal herniorrhaphy in patient who receive either the CollaRx Bupivacaine implant or a plain collagen sponge.
What is the current status of trial NCT01220024?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2010-12-02. Estimated completion is 2011-05-18.
What interventions are being tested in trial NCT01220024?
The interventions under investigation include: Bupivacaine Collagen Sponge (DRUG), Placebo collagen Sponge (DRUG).
Who is sponsoring clinical trial NCT01220024?
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 NCT01220024's enrollment target sits among peer trials
50 1195th of 2000 higher than 740 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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