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

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ClinicalTrials.gov Identifier: NCT00651300
Recruitment Status : Terminated (See Detailed Description field.)
First Posted : April 2, 2008
Last Update Posted : June 11, 2009
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Pain Drug: Parecoxib/Valdecoxib Drug: Placebo Phase 3

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  (Clinical Trial)
Actual Enrollment : 91 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : April 2003
Study Completion Date : March 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Valdecoxib
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Group 1 Drug: Parecoxib/Valdecoxib
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 Drug: Placebo
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



Primary Outcome Measures :
  1. Total intake of morphine in first 4 hours post-surgery upon waking of patients receiving parecoxib versus control group. [ Time Frame: 4 hours ]

Secondary Outcome Measures :
  1. Evaluation of unplanned hospital admissions on Day 4. [ Time Frame: 4 days ]
  2. Health Outcomes Recovery Questionnaire on Days 2, 3, and 4. [ Time Frame: 4 days ]
  3. 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. Length of stay on Day 1. [ Time Frame: 1 day ]
  5. Patient Satisfaction Questionnaire on Days 1 and 4. [ Time Frame: 4 days ]
  6. Quality of Recovery Score on Days 1, 2, and 3. [ Time Frame: 3 days ]
  7. Numerical Rating Scale on Days 1 (hourly for 6 hours), 2, 3, and 4. [ Time Frame: 4 days ]
  8. Modified Brief Pain Inventory on Days 2, 3, and 4. [ Time Frame: 4 days ]
  9. Readiness for discharge on Day 1. [ Time Frame: 1 day ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00651300


Locations
Australia, New South Wales
Pfizer Investigational Site
Port Macquarie, New South Wales, Australia
Pfizer Investigational Site
Randwick, New South Wales, Australia, 2031
Pfizer Investigational Site
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Pfizer Investigational Site
Coopers Plain, Queensland, Australia, 4108
Pfizer Investigational Site
Townsville, Queensland, Australia, 4814
Australia, Victoria
Pfizer Investigational Site
Heidelberg, Victoria, Australia, 3084
Pfizer Investigational Site
Prahran, Victoria, Australia, 3181
Australia, Western Australia
Pfizer Investigational Site
Perth, Western Australia, Australia, 6847
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00651300     History of Changes
Other Study ID Numbers: PARA-0505-086
A3481026
First Posted: April 2, 2008    Key Record Dates
Last Update Posted: June 11, 2009
Last Verified: June 2009

Additional relevant MeSH terms:
Parecoxib
Valdecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents