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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

Primary Purpose

Pain, Post Surgical

Status
Terminated
Phase
Phase 4
Locations
Argentina
Study Type
Interventional
Intervention
parecoxib/valdecoxib
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Post Surgical focused on measuring laparoscopy

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Arm 1

Arm Description

Outcomes

Primary Outcome Measures

Visual Analog Scale Pain Intensity (0-100 mm), which was evaluated using the change from baseline

Secondary Outcome Measures

Visual Analog Scale Pain Intensity
Categorical Pain Intensity
Patient pain relief
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
Dyspepsia
Adverse events
Patient Global Evaluation

Full Information

First Posted
April 1, 2008
Last Updated
April 21, 2008
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00660855
Brief Title
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
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Terminated
Why Stopped
See Detailed Description.
Study Start Date
June 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Post Surgical
Keywords
laparoscopy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
parecoxib/valdecoxib
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual Analog Scale Pain Intensity (0-100 mm), which was evaluated using the change from baseline
Time Frame
Day 3
Secondary Outcome Measure Information:
Title
Visual Analog Scale Pain Intensity
Time Frame
Day 7
Title
Categorical Pain Intensity
Time Frame
Day 3 and Day 7
Title
Patient pain relief
Time Frame
Day 3 and Day 7
Title
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
Title
Dyspepsia
Time Frame
Study endpoint
Title
Adverse events
Time Frame
Day 1, Day 3, and Day 7
Title
Patient Global Evaluation
Time Frame
Day 3 and Day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Buenos Aires
ZIP/Postal Code
C1230AAW
Country
Argentina
Facility Name
Pfizer Investigational Site
City
Buenos Aires
ZIP/Postal Code
C1280AEB
Country
Argentina

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3471107&StudyName=A%20Multicenter%2C%20Open%20Label%20Trial%20to%20evaluate%20pain%20relief%20with%20intravenous%20followed%20by%20oral%20therapy%20with%20parecoxib/valdecoxib%2040%20mg/day%20
Description
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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

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