Efficacy and Safety of ALGRX 4975 in Treatment of Postoperative Pain After Hernia Repair
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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 |
- 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
| Estimated Enrollment: | 40 |
| Study Start Date: | September 2005 |
| Estimated Study Completion Date: | February 2006 |
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 |
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 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 May 19, 2013