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

This study has been completed.
Sponsor:
Information provided by:
AlgoRx Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00146198
First received: September 4, 2005
Last updated: December 18, 2006
Last verified: December 2006
  Purpose

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 Intervention Phase
Postoperative Pain
Drug: ALGRX 4975
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by AlgoRx Pharmaceuticals:

Primary Outcome Measures:
  • 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:
  • Time to supplemental medication usage
  • 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
  • Safety and tolerability

Estimated Enrollment: 40
Study Start Date: September 2005
Estimated Study Completion Date: February 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00146198

Locations
Denmark
Dagkirurgisk Klinik
Hørsholm, Denmark, DK-2970
Sponsors and Collaborators
AlgoRx Pharmaceuticals
Investigators
Principal Investigator: Henrik Kehlet, MD PhD Rigshospitalet, Denmark
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00146198     History of Changes
Other Study ID Numbers: 4975-2-007-2, Eudra CT No:2004-004670-88
Study First Received: September 4, 2005
Last Updated: December 18, 2006
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by AlgoRx Pharmaceuticals:
Postoperative pain
Inguinal Hernia Repair
Capsaicin

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Pain, Postoperative
Pathological Conditions, Anatomical
Hernia, Abdominal
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on August 01, 2014