At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 50 enrolled
Drug / intervention
Bupivacaine Collagen Sponge +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II, Randomized, Single Dose, Double-blind, Placebo Controlled Study to Investigate the Efficacy and Safety Profile of the CollaRx® Bupivacaine Implant (200 mg Bupivacaine Hydrochloride) in Men After Open Laparotomy Herniorrhaphy
In Brief
A Phase 2 clinical trial evaluating Bupivacaine Collagen Sponge and Placebo collagen Sponge for Herniorrhaphy and 2 related conditions. Completed, enrolled 50 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHerniorrhaphy, Postoperative Pain, Inguinal Hernia
CountriesUnited States
CollaboratorsPremier Research
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedOct 2010
Enrollment StartDec 2010
Primary CompletionMay 2011
TodayJul 2026
First PostedOct 13, 2010
Enrollment StartDec 2, 2010
Primary CompletionMay 18, 2011
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 15.7 years ago
Interventions
Bupivacaine Collagen Spongedrug
Drug: Bupivacaine Collagen Sponge
Placebo collagen Spongedrug
Drug: Placebo Collagen Sponge