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

• Sponsor: AlgoRx Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00146198
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Duration (Months): 5
• Patients Per Site Per Month: 8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain	Drug: ALGRX 4975	Phase 2

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 Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• 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
• Study Start Date: Sep 1, 2005
• Study Completion Date: Feb 1, 2006

Outcome Measures

Primary Outcome Measures

1. 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

1. Time to supplemental medication usage []

2. 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 []

3. Safety and tolerability []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dagkirurgisk Klinik	Hørsholm		Denmark	DK-2970

Sponsors and Collaborators

• AlgoRx Pharmaceuticals

Investigators

• Principal Investigator: Henrik Kehlet, MD PhD, Rigshospitalet, Denmark

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00146198
• Other Study ID Numbers: 4975-2-007-2; Eudra CT No:2004-004670-88
• First Posted: Sep 7, 2005
• Last Update Posted: Dec 20, 2006
• Last Verified: Dec 1, 2006

• Keywords provided by , ,: Postoperative pain; Inguinal Hernia Repair; Capsaicin
• Additional relevant MeSH terms: Pain, Postoperative; Hernia

Study Results

No Results Posted as of Dec 20, 2006