Back to resultsEfficacy and Safety of ALGRX 4975 in Treatment of Postoperative Pain After Hernia Repair
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
ALGRX 4975
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain focused on measuring Postoperative pain, Inguinal Hernia Repair, Capsaicin
Eligibility 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
Sites / Locations
- Dagkirurgisk Klinik
Outcomes
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
Full Information
NCT ID
NCT00146198
First Posted
September 4, 2005
Last Updated
December 18, 2006
Sponsor
AlgoRx Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00146198
Brief Title
Efficacy and Safety of ALGRX 4975 in Treatment of Postoperative Pain After Hernia Repair
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2006
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
AlgoRx Pharmaceuticals
4. Oversight
5. Study Description
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 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Postoperative pain, Inguinal Hernia Repair, Capsaicin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
40 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
ALGRX 4975
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Time to supplemental medication usage
Title
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
Title
Safety and tolerability
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henrik Kehlet, MD PhD
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dagkirurgisk Klinik
City
Hørsholm
ZIP/Postal Code
DK-2970
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of ALGRX 4975 in Treatment of Postoperative Pain After Hernia Repair
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