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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: ALGRX 4975


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ALGRX 4975|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative pain, Open cholecystectomy, Capsaicin