A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Analgesic Efficacy, Safety and Tolerability of ALGRX 4975 in Subjects After Inguinal Hernia Repair
Sponsor study identifier
Secondary identifiers
interventional
40
1 country
1
Study Start
September 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
February 2006
Date type not reportedThis date has not been verified as actual or estimated.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2006
Date type not reportedThis date has not been verified as actual or estimated.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2005
Date type not reportedThis date has not been verified as actual or estimated.
September 4, 2005
Actual (reported)September 7, 2005
Actual (reported)February 2006
Date type not reportedThis date has not been verified as actual or estimated.
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.
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
Dagkirurgisk Klinik
Hørsholm, DK-2970, Denmark
Henrik Kehlet, MD PhD
Copenhagen University Hospital, Rigshospitalet
First Submitted
September 4, 2005
First Posted
September 7, 2005
Study Start
September 2005
Date type not reportedThis date has not been verified as actual or estimated.
Study Completion
February 2006
Date type not reportedDipyrone Versus Acetaminophen in the Control of Postoperative Pain
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This date has not been verified as actual or estimated.
Last Updated
December 20, 2006
Record last verified: 2006-12
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