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

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 August 29, 2008

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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