A Phase 3 interventional study of Parecoxib/Valdecoxib and Placebo in Pain, sponsored by Pfizer. Terminated at 8 sites in Australia. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2009-06-11.
Sponsored by Pfizer · Phase 3, Interventional, and Treatment
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.
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.
Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Parecoxib/Valdecoxib
Drug: Placebo
A single 40mg dose of intravenous (IV) parecoxib sodium administered on Day 1 immediately before the surgical procedure as part of the Investigator's usual analgesic management practice, followed by oral doses of valdecoxib 40 mg (2 x 20 mg tablets) at 6-8 hours post-surgery on Day 1 and in the morning of Day 2 and Day 3
A single dose of IV saline (placebo) administered on Day 1 immediately before the surgical procedure as part of the Investigator's usual analgesic management practice, followed by oral doses of placebo (2 x matching valdecoxib 20 mg tablets) at 6-8 hours post-surgery on Day 1 and in the morning of Day 2 and Day 3
Total intake of morphine in first 4 hours post-surgery upon waking of patients receiving parecoxib versus control group.
Time frame: 4 hours
Evaluation of unplanned hospital admissions on Day 4.
Time frame: 4 days
Health Outcomes Recovery Questionnaire on Days 2, 3, and 4.
Time frame: 4 days
Collection of adverse events immediately before surgery, 1 and 6 hours after surgery, and on Days 2, 3, and 4.
Time frame: 4 days
Length of stay on Day 1.
Time frame: 1 day
Patient Satisfaction Questionnaire on Days 1 and 4.
Time frame: 4 days
Quality of Recovery Score on Days 1, 2, and 3.
Time frame: 3 days
Numerical Rating Scale on Days 1 (hourly for 6 hours), 2, 3, and 4.
Time frame: 4 days
Modified Brief Pain Inventory on Days 2, 3, and 4.
Time frame: 4 days
Readiness for discharge on Day 1.
Time frame: 1 day
This study is terminated, as verified in Jun 2009. You cannot join it, but the record below documents what was studied.
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