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

Phase 3

Completed

• Conditions: Laparoscopic Cholecystectomy; Pain
• Interventions: Drug: placebo; Drug: valdecoxib

• Registration Number: NCT00661635
• Lead Sponsor: Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-11
• Study Completion: 2003-07
• Status Verified: 2008-03
• Study First Submitted: 2008-03-31
• Study First Submitted QC: 2008-04-15
• Study First Posted: 2008-04-18
• Last Update Submitted: 2008-04-21
• Last Update Posted: 2008-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 490

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 3	placebo	-
Arm 1	valdecoxib	-
Arm 2	valdecoxib	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Amount of rescue medication taken	Days 2 to 5
Time between doses of study medication	Days 2 to 5
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
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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Madison, Wisconsin, United States