Status:
COMPLETED
Efficacy and Safety of ALGRX 4975 in the Treatment of Postoperative Pain After Gall Bladder Removal
Lead Sponsor:
AlgoRx Pharmaceuticals
Conditions:
Postoperative Pain
Eligibility:
All Genders
20-65 years
Phase:
PHASE2
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 poten...
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 incr...
Eligibility Criteria
Inclusion
- Subjects undergoing open cholecystectomy with the subcostal approach for cholelithiasis/cholecystitis
- American Society of Anesthesiologists (ASA) Class I or II
Exclusion
- Active pancreatitis, any obstruction of the biliary tree, or hyperbilirubinemia (total bilirubin \> 2.5 mg/dL)
- Previous abdominal surgical procedure with the exception of inguinal hernia repair or appendectomy by the lateral approach or cesarean section or hysterectomy if the surgery was performed more than 1 year prior to study participation and the subject experienced no postoperative complications
- Diabetes mellitus with HbA1C \> 9.5 or a history of prolonged uncontrolled diabetes mellitus
- Systolic blood pressure greater than 150 mmHg or diastolic greater than 95 mmHg
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
End Date :
December 1 2005
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00133133
Start Date
July 1 2005
End Date
December 1 2005
Last Update
December 20 2006
Active Locations (1)
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1
Emergency Center, Clinical Center of Serbia
Belgrade, Serbia and Montenegro, 11000