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

Phase 3TerminatedNCT00651300

Pfizer91 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Pain

Interventions

Parecoxib/ValdecoxibDRUG

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

PlaceboDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (8)

Pfizer Investigational Site

Port Macquarie, New South Wales, Australia

Pfizer Investigational Site

Randwick, New South Wales, Australia

Pfizer Investigational Site

Westmead, New South Wales, Australia

Pfizer Investigational Site

Coopers Plain, Queensland, Australia

Outcomes

Primary Outcomes

Total intake of morphine in first 4 hours post-surgery upon waking of patients receiving parecoxib versus control group.

Time frame: 4 hours

Secondary Outcomes

Evaluation of unplanned hospital admissions on Day 4.

Time frame: 4 days

Health Outcomes Recovery Questionnaire on Days 2, 3, and 4.

Time frame: 4 days

Collection of adverse events immediately before surgery, 1 and 6 hours after surgery, and on Days 2, 3, and 4.

Time frame: 4 days

Length of stay on Day 1.

Time frame: 1 day

Patient Satisfaction Questionnaire on Days 1 and 4.

Time frame: 4 days

Quality of Recovery Score on Days 1, 2, and 3.

Time frame: 3 days

Numerical Rating Scale on Days 1 (hourly for 6 hours), 2, 3, and 4.

Time frame: 4 days

Modified Brief Pain Inventory on Days 2, 3, and 4.

Time frame: 4 days

Readiness for discharge on Day 1.

Time frame: 1 day

Data from ClinicalTrials.gov

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