A Multicenter, Open Label Trial To Evaluate Pain Relief With Intravenous Followed By Oral Therapy With Parecoxib/Valdecoxib 40 Mg/Day For Treatment Of Post-Laparoscopic Surgery Pain

April 21, 2008 updated by: Pfizer

A Multicenter, Open Label Trial To Evaluate Analgesic Effect Of Intravenous And Subsequent Oral Therapy With Parecoxib/Valdecoxib (Bextra® IM/IV And Bextra®) 40 Mg/Day For Treatment Of Post-Laparoscopic Surgery Pain

The objectives of this study were to assess the analgesic efficacy and safety of parecoxib/valdecoxib on post-laparoscopic surgery analgesia.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This study A3471107 was terminated on February 4th, 2005 due to enrollment difficulties, problems related to need for rescue medication, and perceptions about cardiovascular risk potentially associated with all NSAIDs.

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1230AAW
        • Pfizer Investigational Site
      • Buenos Aires, Argentina, C1280AEB
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who had undergone laparoscopic surgery
  • Patients in need of post-surgical analgesia

Exclusion Criteria:

  • Patients with an unexpected surgical complication which, in the Investigator's opinion, placed the patient at significantly higher risk for post-surgical complication(s), or for non-routine post-operative care requirements
  • Patients who took any nonsteroidal anti-inflammatory drug or any analgesic within 48 hours prior to surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Arm 1
Drug: parecoxib/valdecoxib
parecoxib 40 mg intravenously after recovery from anesthesia; if pain persisted, the patient could receive an optional second drug dose on Study Day 1 (only) if more than 4 hours after the first dose. When the patient was able to tolerate oral medication, one valdecoxib 40 mg tablet was administered by mouth once daily in the morning until a maximum period of 7 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Visual Analog Scale Pain Intensity (0-100 mm), which was evaluated using the change from baseline
Time Frame: Day 3
Day 3

Secondary Outcome Measures

Outcome Measure
Time Frame
Visual Analog Scale Pain Intensity
Time Frame: Day 7
Day 7
Categorical Pain Intensity
Time Frame: Day 3 and Day 7
Day 3 and Day 7
Patient pain relief
Time Frame: Day 3 and Day 7
Day 3 and Day 7
Composite Upper Gastrointestinal (UGI) Tolerability measure was calculated; an UGI event was considered if the patient reported at least one of the following: moderate or severe nausea, or moderate or severe abdominal pain, or moderate or severe
Time Frame: Study endpoint
Study endpoint
Dyspepsia
Time Frame: Study endpoint
Study endpoint
Adverse events
Time Frame: Day 1, Day 3, and Day 7
Day 1, Day 3, and Day 7
Patient Global Evaluation
Time Frame: Day 3 and Day 7
Day 3 and Day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Study Completion (ACTUAL)

July 1, 2004

Study Registration Dates

First Submitted

April 1, 2008

First Submitted That Met QC Criteria

April 16, 2008

First Posted (ESTIMATE)

April 17, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

April 22, 2008

Last Update Submitted That Met QC Criteria

April 21, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A3471107

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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