NCT00651300

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P25-P50 for phase_3 pain

Timeline
Completed

Started Apr 2003

Geographic Reach
1 country

8 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2004

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

March 31, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 2, 2008

Completed
Last Updated

June 11, 2009

Status Verified

June 1, 2009

First QC Date

March 31, 2008

Last Update Submit

June 8, 2009

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

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

    4 hours

Secondary Outcomes (9)

  • Evaluation of unplanned hospital admissions on Day 4.

    4 days

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

    4 days

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

    4 days

  • Length of stay on Day 1.

    1 day

  • Patient Satisfaction Questionnaire on Days 1 and 4.

    4 days

  • +4 more secondary outcomes

Study Arms (2)

Group 1

EXPERIMENTAL
Drug: Parecoxib/Valdecoxib

Group 2

PLACEBO COMPARATOR
Drug: Placebo

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

Group 1
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

Group 2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Pfizer Investigational Site

Port Macquarie, New South Wales, Australia

Location

Pfizer Investigational Site

Randwick, New South Wales, 2031, Australia

Location

Pfizer Investigational Site

Westmead, New South Wales, 2145, Australia

Location

Pfizer Investigational Site

Coopers Plain, Queensland, 4108, Australia

Location

Pfizer Investigational Site

Townsville, Queensland, 4814, Australia

Location

Pfizer Investigational Site

Heidelberg, Victoria, 3084, Australia

Location

Pfizer Investigational Site

Prahran, Victoria, 3181, Australia

Location

Pfizer Investigational Site

Perth, Western Australia, 6847, Australia

Location

Related Links

MeSH Terms

Conditions

Pain

Interventions

parecoxibvaldecoxib

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 31, 2008

First Posted

April 2, 2008

Study Start

April 1, 2003

Study Completion

March 1, 2004

Last Updated

June 11, 2009

Record last verified: 2009-06

Locations

AU(8)