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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Analgesic Efficacy, Safety and Tolerability of ALGRX 4975 in Subjects After Inguinal Hernia Repair

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: ALGRX 4975


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ALGRX 4975|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative pain, Inguinal Hernia Repair, Capsaicin