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

AlgoRx Pharmaceuticals

Status and phase

Completed

Phase 2

Conditions

Postoperative Pain

Treatments

Drug: ALGRX 4975

Study type

Interventional

Funder types

Industry

Identifiers

NCT00146198

Eudra CT No:2004-004670-88

4975-2-007-2

Details and patient eligibility

About

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.

Full 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.

Sex

Male

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria