A Phase 2 interventional study of ALGRX 4975 in Postoperative Pain, sponsored by AlgoRx Pharmaceuticals. Completed at 1 site in Denmark. Open to male participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2006-12-20.
Sponsored by AlgoRx Pharmaceuticals · Phase 2, Interventional, and Treatment
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.
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.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's enrollment of 40 is below the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →AlgoRx Pharmaceuticals is the lead sponsor of 8 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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
This study is completed, as verified in Dec 2006. You cannot join it, but the record below documents what was studied.
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AlgoRx Pharmaceuticals