Status:

COMPLETED

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

Lead Sponsor:

AlgoRx Pharmaceuticals

Conditions:

Postoperative Pain

Eligibility:

MALE

18-70 years

Phase:

PHASE2

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 caps...

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 postope...

Eligibility Criteria

Inclusion

  • • The subject has a primary hernia and will undergo hernia repair by standard Lichtenstein mesh repair.

Exclusion

  • 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

Key Trial Info

Start Date :

September 1 2005

Trial Type :

INTERVENTIONAL

End Date :

February 1 2006

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT00146198

Start Date

September 1 2005

End Date

February 1 2006

Last Update

December 20 2006

Active Locations (1)

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1

Dagkirurgisk Klinik

Hørsholm, Denmark, DK-2970