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

December 18, 2006 updated by: AlgoRx Pharmaceuticals

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Analgesic Efficacy, Safety and Tolerability of ALGRX 4975 in Subjects After Open Cholecystectomy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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 Outcome Measures

Outcome Measure
Safety and tolerability
Pharmacokinetics
Time to first use and total supplemental pain medication use
NRS scores for pain on the first 14 days postoperatively
Spirometry on postoperative days 1 to 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AlgoRx Pharmaceuticals

Investigators

  • Principal Investigator: Slobodan Krstic, MD, Emergency Center, Clinical Center of Serbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Study Completion

December 1, 2005

Study Registration Dates

First Submitted

August 18, 2005

First Submitted That Met QC Criteria

August 18, 2005

First Posted (Estimate)

August 22, 2005

Study Record Updates

Last Update Posted (Estimate)

December 20, 2006

Last Update Submitted That Met QC Criteria

December 18, 2006

Last Verified

February 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4975-2-011-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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