At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 53 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, Safety and Pharmacokinetic Profile of the CollaRx® Bupivacaine Implant in Men After Open Mesh Herniorrhaphy
In Brief
A Phase 2 clinical trial evaluating Bupivacaine Collagen Sponge and placebo collagen sponge for Postoperative Pain and Inguinal Hernia. Completed, enrolled 53 participants across 1 site.
Detailed Summary
The purpose of this study is to determine whether the CollaRx Bupivacaine implant is safe and effective in reducing the amount of narcotic pain medication needed to control pain during the first 24 hours after herniorrhaphy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostoperative Pain, Inguinal Hernia
CountriesUnited States
CollaboratorsPremier Research
Timeline
Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 2008
Enrollment StartMar 2008
Primary CompletionJan 2009
TodayJul 2026
First PostedFeb 29, 2008
Enrollment StartMar 11, 2008
Primary CompletionJan 29, 2009
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 18.3 years ago
Interventions
Bupivacaine Collagen Spongedrug
collagen; Bupivacaine hydrocholoride
placebo collagen spongedrug
collagen