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

Pain Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00651300
• Other study ID #: PARA-0505-086
• Secondary ID: A3481026
• Status: Terminated
• Phase: Phase 3
• First received: March 31, 2008
• Last updated: June 8, 2009
• Start date: April 2003
• Est. completion date: March 2004

Study information

• Verified date: June 2009
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 91
• Est. completion date: March 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

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
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

Locations

Country	Name	City	State
Australia	Pfizer Investigational Site	Coopers Plain	Queensland
Australia	Pfizer Investigational Site	Heidelberg	Victoria
Australia	Pfizer Investigational Site	Perth	Western Australia
Australia	Pfizer Investigational Site	Port Macquarie	New South Wales
Australia	Pfizer Investigational Site	Prahran	Victoria
Australia	Pfizer Investigational Site	Randwick	New South Wales
Australia	Pfizer Investigational Site	Townsville	Queensland
Australia	Pfizer Investigational Site	Westmead	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total intake of morphine in first 4 hours post-surgery upon waking of patients receiving parecoxib versus control group.		4 hours	No
Secondary	Evaluation of unplanned hospital admissions on Day 4.		4 days	No
Secondary	Health Outcomes Recovery Questionnaire on Days 2, 3, and 4.		4 days	No
Secondary	Collection of adverse events immediately before surgery, 1 and 6 hours after surgery, and on Days 2, 3, and 4.		4 days	Yes
Secondary	Length of stay on Day 1.		1 day	No
Secondary	Patient Satisfaction Questionnaire on Days 1 and 4.		4 days	No
Secondary	Quality of Recovery Score on Days 1, 2, and 3.		3 days	No
Secondary	Numerical Rating Scale on Days 1 (hourly for 6 hours), 2, 3, and 4.		4 days	No
Secondary	Modified Brief Pain Inventory on Days 2, 3, and 4.		4 days	No
Secondary	Readiness for discharge on Day 1.		1 day	No

External Links

•   To obtain contact information for a study center near you, click here.