Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00133133
Status:
COMPLETED
Last Update Posted:
2006-12-20
First Post:
2005-08-18
Brief Title:
Efficacy and Safety of ALGRX 4975 in the Treatment of Postoperative Pain After Gall Bladder Removal
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 Open Cholecystectomy
Status:
COMPLETED
Status Verified Date:
2006-02
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:
Postoperative pain after gall bladder removal can be significant mobility limiting and extend hospital stay 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 gall bladder removal
Detailed Description:
Postoperative pain after open cholecystectomy can be significant and mobility limiting causing increased risk of deep venous thrombosis pulmonary complications and extended hospital stay With increasing emphasis on early postoperative mobilization adequate postoperative pain control is essential Acute postoperative pain is currently managed largely with opioids and co-administration of nonsteroidal anti-inflammatory drugs NSAIDS Opioids are highly effective in managing acute postoperative pain however dosing is often limited by side effects such as respiratory depression nausea and vomiting and sedation NSAIDS are administered to reduce opioid use but may also have limiting side effects such as gastrointestinal toxicity and platelet dysfunction New strategies to manage acute postoperative pain would provide clinical benefit 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 open cholecystectomy
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