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Completed

NCT Number: NCT00146198

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

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.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Dagkirurgisk Klinik

Hørsholm, DK-2970, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ALGRX 4975

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

AlgoRx Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2005
Study completion
2006
First posted
Sep 7, 2005
Registry last updated
Dec 20, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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