Efficacy and Safety of ALGRX 4975 in Treatment of Postoperative Pain After Hernia Repair

Phase 2

Completed

• Conditions: Postoperative Pain

• Registration Number: NCT00146198
• Lead Sponsor: AlgoRx Pharmaceuticals

Brief Summary

Hernia repair is one of the most common operations. Whilst there are few complications, pain may last for several weeks and 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. This study will determine whether ALGRX 4975 can provide pain relief following hernia repair.

Detailed Description

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.

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2005-09-04
• Study First Submitted QC: 2005-09-04
• Study First Posted: 2005-09-07
• Study Completion: 2006-02
• Status Verified: 2006-12
• Last Update Submitted: 2006-12-18
• Last Update Posted: 2006-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

• The subject has a primary hernia and will undergo hernia repair by standard Lichtenstein mesh repair.

Exclusion Criteria

• The subject has undergone a lower abdomen surgical procedure in the past.
• The subject is currently scheduled to undergo bilateral inguinal hernia repair.
• Personal or familial contraindications in undergoing general anesthesia.
• Systolic blood pressure greater than 150 mmHg or diastolic greater than 95 mmHg

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The average daily VAS pain scores, assessed on a 100 mm VAS during movement upon arising in the morning and retiring in the evening, during the first week after surgery.

Secondary Outcome Measures

Name	Time	Method
Time to supplemental medication usage
Average daily VAS pain scores, assessed during movement upon arising in the morning and retiring in the evening, during the first 4 weeks after surgery
Safety and tolerability

Trial Locations

Locations (1)

Dagkirurgisk Klinik; 🇩🇰 Hørsholm, Denmark