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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2006-02-28

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.

Conditions

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Postoperative Pain

Keywords

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Postoperative pain Inguinal Hernia Repair Capsaicin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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ALGRX 4975

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Principal Investigators

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Henrik Kehlet, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Locations

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Dagkirurgisk Klinik

Hørsholm, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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Eudra CT No:2004-004670-88

Identifier Type: -

Identifier Source: secondary_id

4975-2-007-2