Clinical trial NCT00651300: A Study of the Recovery Benefits After Treatment With Parecoxib/Valdecoxib in Patients Undergoing Abdominal Surgery
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Pain
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-04-02
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Total intake of morphine in first 4 hours post-surgery upon waking of patients receiving parecoxib versus control group.
timeFrame: 4 hours
Secondary outcomes:
measure: Evaluation of unplanned hospital admissions on Day 4.
timeFrame: 4 days
measure: Health Outcomes Recovery Questionnaire on Days 2, 3, and 4.
timeFrame: 4 days
measure: Collection of adverse events immediately before surgery, 1 and 6 hours after surgery, and on Days 2, 3, and 4.
timeFrame: 4 days
measure: Length of stay on Day 1.
timeFrame: 1 day
measure: Patient Satisfaction Questionnaire on Days 1 and 4.
timeFrame: 4 days
measure: Quality of Recovery Score on Days 1, 2, and 3.
timeFrame: 3 days
measure: Numerical Rating Scale on Days 1 (hourly for 6 hours), 2, 3, and 4.
timeFrame: 4 days
measure: Modified Brief Pain Inventory on Days 2, 3, and 4.
timeFrame: 4 days
measure: Readiness for discharge on Day 1.
timeFrame: 1 day
Other outcomes:
Locations:
city: Port Macquarie
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: Randwick
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: Westmead
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: Coopers Plain
country: Australia
facility: Pfizer Investigational Site
state: Queensland
city: Townsville
country: Australia
facility: Pfizer Investigational Site
state: Queensland
city: Heidelberg
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: Prahran
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: Perth
country: Australia
facility: Pfizer Investigational Site
state: Western Australia
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: