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

Postoperative Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00133133
• Other study ID #: 4975-2-011-2
• Status: Completed
• Phase: Phase 2
• First received: August 18, 2005
• Last updated: December 18, 2006
• Start date: July 2005
• Est. completion date: December 2005

Study information

• Verified date: February 2006
• Source: AlgoRx Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Serbia and Montenegro: Agency for Drugs and Medicinal Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• ALGRX 4975

Locations

Country	Name	City	State
Former Serbia and Montenegro	Emergency Center, Clinical Center of Serbia	Belgrade

Sponsors (1)

Lead Sponsor	Collaborator
AlgoRx Pharmaceuticals

Country where clinical trial is conducted

Former Serbia and Montenegro, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average numeric rating scale (NRS) scores for pain on ambulation assessed in the evening on the day of surgery and the first four postoperative days
Secondary	Time to first use and total supplemental pain medication use
Secondary	NRS scores for pain on the first 14 days postoperatively
Secondary	Spirometry on postoperative days 1 to 4
Secondary	Safety and tolerability
Secondary	Pharmacokinetics