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NCT01224145 · ClinicalTrials.gov registry record · Phase 2
Assess the Feasibility and Efficacy of the CollaRx® Bupivacaine Implant Laparoscopic Inguinal or Umbilical Herniorrhaphy
A Phase 2 study of Postoperative Pain and Hernia, sponsored by Innocoll.
- Completed
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT01224145: Completed Phase 2 study of Postoperative Pain and Hernia, sponsored by Innocoll.
NCT01224145 is a Phase 2 study of Postoperative Pain and Hernia that has completed, run by Innocoll. The registered enrollment target is 10 participants, below the 232-participant average among 120 other Postoperative Pain trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01224145, a Phase 2 study of Postoperative Pain and Hernia, has completed, sponsored by Innocoll.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will assess pain intensity for the first 72 hrs after aggravated movement (cough) following Laparoscopic Inguinal or Umbilical Herniorrhaphy.
Primary Outcome
Dosages of 1 to 2 mg per dose were titrated to patient comfort according to institutional standards and at the investigator's discretion. Once patients could tolerate oral medication, they were offered oral morphine (15 mg tablets) as rescue analgesia if necessary. The dose for patients who weighed less than 75kg was 15mg every 3 to 4 hours as needed for pain control. The dose for patients who weighed 75kg or more was 1-2 tablets (15-30 mg) every 3-4 hours for pain control. Morphine was the pref
Conditions Studied
Interventions
- DRUG 5x5cm bupivacaine collagen sponges
Study Locations (1)
Texas
- Research Concepts - Bellaire
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2011-03-22 |
| Est. Completion | 2011-06-20 |
| Phase | Phase 2 |
What the finished NCT01224145 record still lists
NCT01224145 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 232-participant average among 120 other Postoperative Pain trials with a reported enrollment target (96% lower).
The record links to 2 conditions, with Postoperative Pain appearing as the primary indexed condition, and to 1 intervention - of which 5x5cm bupivacaine collagen sponges is the first listed.
NCT01224145 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT01224145 about?
NCT01224145 is a clinical study titled "Assess the Feasibility and Efficacy of the CollaRx® Bupivacaine Implant Laparoscopic Inguinal or Umbilical Herniorrhaphy". This study will assess pain intensity for the first 72 hrs after aggravated movement (cough) following Laparoscopic Inguinal or Umbilical Herniorrhaphy.
What is the current status of trial NCT01224145?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2011-03-22. Estimated completion is 2011-06-20.
What conditions does trial NCT01224145 study?
This clinical trial studies the following conditions: Postoperative Pain, Hernia.
What interventions are being tested in trial NCT01224145?
The interventions under investigation include: 5x5cm bupivacaine collagen sponges (DRUG).
Who is sponsoring clinical trial NCT01224145?
This trial is sponsored by Innocoll, which has 19 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01224145 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Postoperative Pain
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01224145's enrollment target sits among peer trials
10 120th of 120 higher than 1 of 120 other Postoperative Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Postoperative Pain 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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