Efficacy and Safety of ALGRX 4975 in the Treatment of Postoperative Pain After Gall Bladder Removal - Full Text View

Purpose

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.

Condition	Intervention	Phase
Postoperative Pain	Drug: ALGRX 4975	Phase II

Drug Information available for:

Capsaicin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

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

Further study details as provided by AlgoRx Pharmaceuticals:

Primary Outcome Measures:

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:

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
Safety and tolerability
Pharmacokinetics

Estimated Enrollment:	40
Study Start Date:	July 2005
Estimated Study Completion Date:	December 2005

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.

Eligibility

Ages Eligible for Study:	20 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00133133

Locations


Serbia and Montenegro
	Emergency Center, Clinical Center of Serbia
	Belgrade, Serbia and Montenegro, 11000

Sponsors and Collaborators

AlgoRx Pharmaceuticals

Investigators


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

More Information

Study ID Numbers:	4975-2-011-2
First Received:	August 18, 2005
Last Updated:	December 18, 2006
ClinicalTrials.gov Identifier:	NCT00133133
Health Authority:	Serbia and Montenegro: Agency for Drugs and Medicinal Devices

Keywords provided by AlgoRx Pharmaceuticals:

Postoperative pain

Open cholecystectomy

Capsaicin

Study placed in the following topic categories:

Signs and Symptoms

Postoperative Complications

Pain

Capsaicin

Pain, Postoperative

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on November 05, 2008

Sponsored by:	AlgoRx Pharmaceuticals
Information provided by:	AlgoRx Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00133133