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

This study has been terminated.
(See Detailed Description field.)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00651300
First received: March 31, 2008
Last updated: June 8, 2009
Last verified: June 2009
  Purpose

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 Intervention Phase
Pain
Drug: Parecoxib/Valdecoxib
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Total intake of morphine in first 4 hours post-surgery upon waking of patients receiving parecoxib versus control group. [ Time Frame: 4 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluation of unplanned hospital admissions on Day 4. [ Time Frame: 4 days ] [ Designated as safety issue: No ]
  • Health Outcomes Recovery Questionnaire on Days 2, 3, and 4. [ Time Frame: 4 days ] [ Designated as safety issue: No ]
  • Collection of adverse events immediately before surgery, 1 and 6 hours after surgery, and on Days 2, 3, and 4. [ Time Frame: 4 days ] [ Designated as safety issue: Yes ]
  • Length of stay on Day 1. [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Patient Satisfaction Questionnaire on Days 1 and 4. [ Time Frame: 4 days ] [ Designated as safety issue: No ]
  • Quality of Recovery Score on Days 1, 2, and 3. [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • Numerical Rating Scale on Days 1 (hourly for 6 hours), 2, 3, and 4. [ Time Frame: 4 days ] [ Designated as safety issue: No ]
  • Modified Brief Pain Inventory on Days 2, 3, and 4. [ Time Frame: 4 days ] [ Designated as safety issue: No ]
  • Readiness for discharge on Day 1. [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Enrollment: 91
Study Start Date: April 2003
Study Completion Date: March 2004
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00651300     History of Changes
Other Study ID Numbers: PARA-0505-086, A3481026
Study First Received: March 31, 2008
Last Updated: June 8, 2009
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

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

ClinicalTrials.gov processed this record on November 27, 2014