A Study of the Recovery Benefits After Treatment With Parecoxib/Valdecoxib in Patients Undergoing Abdominal Surgery

Phase 3

Terminated

• Conditions: Pain
• Interventions: Drug: Parecoxib/Valdecoxib; Drug: Placebo

• Registration Number: NCT00651300
• Lead Sponsor: Pfizer

Brief Summary

The purpose of this study is to evaluate morphine intake in the first 4 hours after abdominal surgery. Morphine intake is compared between patients on placebo and patients on parecoxib/valdecoxib.

Detailed Description

This study was prematurely terminated because subject recruitment was slower than expected, it was determined that the study was not going to achieve the statistical power necessary to address the primary objective. Letters were sent to the sites informing them of study termination on 26 February 2004. The decision to terminate the trial was not based on any safety concerns.

Study Timeline

• Study Start: 2003-04
• Study Completion: 2004-03
• Study First Submitted: 2008-03-31
• Study First Submitted QC: 2008-03-31
• Study First Posted: 2008-04-02
• Status Verified: 2009-06
• Last Update Submitted: 2009-06-08
• Last Update Posted: 2009-06-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 91

Inclusion Criteria

• Male or female aged 18 to 65 years weighing at least 50 kg but no more than 110 kg undergoing elective intra-peritoneal laparoscopic abdominal surgery
• American Society of Anaesthesiologists (ASA) Physical Status I-III

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Exclusion Criteria

• Significant chronic disease, such as renal, hepatic, cardiovascular, or respiratory, which would contraindicate participation in the study or interfere with interpretation of study results
• Active gastrointestinal disease, chronic or acute renal or hepatic disorder, or known coagulation defect

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Parecoxib/Valdecoxib	-
Group 2	Placebo	-

Primary Outcome Measures

Name	Time	Method
Total intake of morphine in first 4 hours post-surgery upon waking of patients receiving parecoxib versus control group.	4 hours

Secondary Outcome Measures

Name	Time	Method
Evaluation of unplanned hospital admissions on Day 4.	4 days
Health Outcomes Recovery Questionnaire on Days 2, 3, and 4.	4 days
Collection of adverse events immediately before surgery, 1 and 6 hours after surgery, and on Days 2, 3, and 4.	4 days
Length of stay on Day 1.	1 day
Patient Satisfaction Questionnaire on Days 1 and 4.	4 days
Quality of Recovery Score on Days 1, 2, and 3.	3 days
Numerical Rating Scale on Days 1 (hourly for 6 hours), 2, 3, and 4.	4 days
Modified Brief Pain Inventory on Days 2, 3, and 4.	4 days
Readiness for discharge on Day 1.	1 day

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇦🇺 Perth, Western Australia, Australia