Efficacy and Safety of ALGRX 4975 in the Treatment of Postoperative Pain After Gall Bladder Removal

• Status: Completed
• Trial end date: 2005-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AlgoRx Pharmaceuticals

Criteria

Inclusion Criteria:

• Subjects undergoing open cholecystectomy with the subcostal approach for cholelithiasis/cholecystitis

• American Society of Anesthesiologists (ASA) Class I or II

Exclusion Criteria:

• 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