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

NCT ID: NCT00133133

Last Updated: 2006-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2005-12-31

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.

Conditions

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Postoperative Pain

Keywords

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Postoperative pain Open cholecystectomy Capsaicin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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ALGRX 4975

Intervention Type DRUG

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AlgoRx Pharmaceuticals

INDUSTRY

Sponsor Role lead

Principal Investigators

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Slobodan Krstic, MD

Role: PRINCIPAL_INVESTIGATOR

Emergency Center, Clinical Center of Serbia

Locations

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Emergency Center, Clinical Center of Serbia

Belgrade, , Serbia and Montenegro

Site Status

Countries

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Serbia and Montenegro

Other Identifiers

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4975-2-011-2

Identifier Type: -

Identifier Source: org_study_id