Efficacy and Safety of ALGRX 4975 in Treatment of Postoperative Pain After Hernia Repair
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Analgesic Efficacy, Safety and Tolerability of ALGRX 4975 in Subjects After Inguinal Hernia Repair
Sponsor: AlgoRx Pharmaceuticals
Listed as NCT00146198, this PHASE2 trial focuses on Postoperative Pain and remains completed. Sponsored by AlgoRx Pharmaceuticals, it has been updated 5 times since 2005, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Study Description(click to expand)Inguinal hernia correction in adults is one of the most common operations with an annual rate of approximately 2,800 per 1 million people in the United States. Whilst there is little intra and postoperative morbidity, pain may persist for one to several weeks postoperatively and may extend the period of convalescence. ALGRX 4975 is an ultra-pure form of capsaicin, which is a pain medicine that has the potential for long-term pain relief following a single administration. The purpose of this study is to determine whether a single dose of ALGRX 4975, administered by instillation, is able to reduce the postoperative pain following inguinal hernia correction and to evaluate the potential for long term pain relief.
Inguinal hernia correction in adults is one of the most common operations with an annual rate of approximately 2,800 per 1 million people in the United States. Whilst there is little intra and postoperative morbidity, pain may persist for one to several weeks postoperatively and may extend the period of convalescence. ALGRX 4975 is an ultra-pure form of capsaicin, which is a pain medicine that has the potential for long-term pain relief following a single administration. The purpose of this study is to determine whether a single dose of ALGRX 4975, administered by instillation, is able to reduce the postoperative pain following inguinal hernia correction and to evaluate the potential for long term pain relief.
Status Flow
Change History
5 versions recorded-
Sep 2024 — Present [monthly]
Completed PHASE2
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Jul 2024 — Sep 2024 [monthly]
Completed PHASE2
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Jan 2021 — Jul 2024 [monthly]
Completed PHASE2
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Jun 2018 — Jan 2021 [monthly]
Completed PHASE2
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Jan 2017 — Jun 2018 [monthly]
Completed PHASE2
First recorded
Sep 2005
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- AlgoRx Pharmaceuticals
For direct contact, visit the study record on ClinicalTrials.gov .