Overview

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

Status:
Completed
Trial end date:
2006-02-01
Target enrollment:
0
Participant gender:
Male
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
AlgoRx Pharmaceuticals
Criteria
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