- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00651300
A Study of the Recovery Benefits After Treatment With Parecoxib/Valdecoxib in Patients Undergoing Abdominal Surgery
June 8, 2009 updated by: Pfizer
A Multicentre, Double-Blind, Placebo-Controlled Study of the Recovery Benefits Following Treatment With a Cox-2 Regimen in Patients Undergoing Elective Laparoscopic Intra-Peritoneal Abdominal Surgery
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
91
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New South Wales
-
Port Macquarie, New South Wales, Australia
- Pfizer Investigational Site
-
Randwick, New South Wales, Australia, 2031
- Pfizer Investigational Site
-
Westmead, New South Wales, Australia, 2145
- Pfizer Investigational Site
-
-
Queensland
-
Coopers Plain, Queensland, Australia, 4108
- Pfizer Investigational Site
-
Townsville, Queensland, Australia, 4814
- Pfizer Investigational Site
-
-
Victoria
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Heidelberg, Victoria, Australia, 3084
- Pfizer Investigational Site
-
Prahran, Victoria, Australia, 3181
- Pfizer Investigational Site
-
-
Western Australia
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Perth, Western Australia, Australia, 6847
- Pfizer Investigational Site
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group 1
|
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
|
Placebo Comparator: Group 2
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Total intake of morphine in first 4 hours post-surgery upon waking of patients receiving parecoxib versus control group.
Time Frame: 4 hours
|
4 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evaluation of unplanned hospital admissions on Day 4.
Time Frame: 4 days
|
4 days
|
Health Outcomes Recovery Questionnaire on Days 2, 3, and 4.
Time Frame: 4 days
|
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
|
4 days
|
Length of stay on Day 1.
Time Frame: 1 day
|
1 day
|
Patient Satisfaction Questionnaire on Days 1 and 4.
Time Frame: 4 days
|
4 days
|
Quality of Recovery Score on Days 1, 2, and 3.
Time Frame: 3 days
|
3 days
|
Numerical Rating Scale on Days 1 (hourly for 6 hours), 2, 3, and 4.
Time Frame: 4 days
|
4 days
|
Modified Brief Pain Inventory on Days 2, 3, and 4.
Time Frame: 4 days
|
4 days
|
Readiness for discharge on Day 1.
Time Frame: 1 day
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2003
Study Completion (Actual)
March 1, 2004
Study Registration Dates
First Submitted
March 31, 2008
First Submitted That Met QC Criteria
March 31, 2008
First Posted (Estimate)
April 2, 2008
Study Record Updates
Last Update Posted (Estimate)
June 11, 2009
Last Update Submitted That Met QC Criteria
June 8, 2009
Last Verified
June 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Cyclooxygenase 2 Inhibitors
- Valdecoxib
- Parecoxib
Other Study ID Numbers
- PARA-0505-086
- A3481026
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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