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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00146198
• Other study ID #: 4975-2-007-2
• Secondary ID: Eudra CT No:2004
• Status: Completed
• Phase: Phase 2
• First received: September 4, 2005
• Last updated: December 18, 2006
• Start date: September 2005
• Est. completion date: February 2006

Study information

• Verified date: December 2006
• Source: AlgoRx Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• ALGRX 4975

Locations

Country	Name	City	State
Denmark	Dagkirurgisk Klinik	Hørsholm

Sponsors (1)

Lead Sponsor	Collaborator
AlgoRx Pharmaceuticals

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time to supplemental medication usage
Secondary	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
Secondary	Safety and tolerability