Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00146198
Status:
COMPLETED
Last Update Posted:
2006-12-20
First Post:
2005-09-04
Brief Title:
Efficacy and Safety of ALGRX 4975 in Treatment of Postoperative Pain After Hernia Repair
Sponsor:
AlgoRx Pharmaceuticals
Organization:
AlgoRx Pharmaceuticals
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2006-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 2800 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Eudra CT No2004-004670-88 | None | None | None |