A Randomized, Double-Blind Study of the Efficacy and Safety of Valdecoxib Compared to Placebo for Treatment of Post- Cholecystectomy Surgery Pain

Study Overview
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Brief Summary
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To evaluate the analgesic efficacy, general safety, and effects on health outcome measures and opioid-related symptoms of 2 valdecoxib dosing regimens compared with placebo in patients with moderate or severe pain following laparoscopic cholecystectomy surgery.

Official Title
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A Multiple-Dose, Randomized, Double-Blind, Placebo-Controlled Study of the Analgesic Efficacy and Safety of Valdecoxib Compared to Placebo in Patients for Treatment of Post-Surgical Pain From Laparoscopic Cholecystectomy Surgery

Conditions
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Laparoscopic Cholecystectomy, Pain

Intervention / Treatment
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* Drug: placebo
* Drug: valdecoxib
* Drug: valdecoxib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients had required an elective, non-urgent laparoscopic cholecystectomy, as an outpatient procedure, with ASA Class I-III, with a Baseline Pain Intensity of moderate or severe on a categorical scale and ≥45 mm on a VAS (100 mm) Patients were able to get their first dose of study medication within 8 hours after the end of surgery Exclusion Criteria: Patients could not undergo procedures expected to produce a greater degree of surgical trauma than the laparoscopic cholecystectomy alone, nor have acute pre-operative pain (other than biliary colic) nor chronic pain conditions, nor uncontrolled chronic conditions, nor cancer, nor a laboratory abnormality that the investigator considered to contraindicate study participation Patient had any cognitive impairment that would, in the investigator's opinion, preclude study participation or compliance with protocol mandated procedures Patient had a history of known alcohol, analgesic, or narcotic substance abuse within the one year prior to Screening Patient had any laboratory abnormality at screening, that, in the opinion of the investigator, is not due to the condition requiring surgery and is not expected to resolve post-surgery, and would, therefore, contraindicate study participation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1<br> | Drug: valdecoxib<br>* valdecoxib 40 mg by mouth within 8 hours after the end of surgery, followed by a second dose of valdecoxib 20 mg within 1 to 12 hours (or by midnight on the Day 1, whichever was earlier); then, valdecoxib 20 mg twice daily (BID) on Days 2 to 5.<br>|
| Active Comparator: Arm 2<br> | Drug: valdecoxib<br>* valdecoxib 40 mg by mouth within 8 hours after the end of surgery, followed by a second dose of valdecoxib 20 mg within 1 to 12 hours (or by midnight on the Day 1, whichever was earlier); then, valdecoxib 20 mg once daily (QD)on Days 2 to 5.<br>|
| Placebo Comparator: Arm 3<br> | Drug: placebo<br>* valdecoxib 40 mg by mouth within 8 hours after the end of surgery, followed by a second dose of valdecoxib 20 mg within 1 to 12 hours (or by midnight on the Day 1, whichever was earlier); then, placebo twice daily (BID) on Days 2 to 5<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient's Global Evaluation of Study Medication |  | Day 2 and Day 3 | 
| Summed Pain Intensity (categorical) through 24 hours (SPI 24) |  | Day 2 and Day 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time-specific PI (VAS) |  | Days 2 to 5 | 
| Patient's Global Evaluation of Study Medication |  | Day 4 and Day 5 | 
| Time to first dose of rescue medication |  | Days 2 to 5 | 
| Percent of patients who took rescue medication on each study day |  | Days 2 to 5 | 
| Amount of rescue medication taken |  | Days 2 to 5 | 
| Time between doses of study medication |  | Days 2 to 5 | 
| Worst PI (derived from the mBPI-SF) |  | Days 2 to 5 | 
| Average PI (derived from the mBPI-SF) |  | Days 2 to 5 | 
| SPI 24 (categorical) |  | Day 4 and Day 5 | 
| Time-specific PI (categorical) |  | Days 2 to 5 | 
| SPI 24 (VAS) |  | Days 2 to 5 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparoscopic Cholecystectomy Surgery, Acute Pain, Perioperative Pain