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”

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 Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

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.

Intervention(s) in this Clinical Trial

• 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
• 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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Group 1
• Placebo Comparator: Group 2

Primary Measures

• Total intake of morphine in first 4 hours post-surgery upon waking of patients receiving parecoxib versus control group.
  • Time Frame: 4 hours
    Safety Issue?: No

Secondary Measures

• Evaluation of unplanned hospital admissions on Day 4.
  • Time Frame: 4 days
    Safety Issue?: No
• Health Outcomes Recovery Questionnaire on Days 2, 3, and 4.
  • Time Frame: 4 days
    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
    Safety Issue?: Yes
• Length of stay on Day 1.
  • Time Frame: 1 day
    Safety Issue?: No
• Patient Satisfaction Questionnaire on Days 1 and 4.
  • Time Frame: 4 days
    Safety Issue?: No
• Quality of Recovery Score on Days 1, 2, and 3.
  • Time Frame: 3 days
    Safety Issue?: No
• Numerical Rating Scale on Days 1 (hourly for 6 hours), 2, 3, and 4.
  • Time Frame: 4 days
    Safety Issue?: No
• Modified Brief Pain Inventory on Days 2, 3, and 4.
  • Time Frame: 4 days
    Safety Issue?: No
• Readiness for discharge on Day 1.
  • Time Frame: 1 day
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00651300

Study ID Number: PARA-0505-086

ClinicalTrials.gov Identifier: NCT00651300

Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

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