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

Phase 4

Terminated

• Conditions: Pain, Post Surgical
• Interventions: Drug: parecoxib/valdecoxib

• Registration Number: NCT00660855
• Lead Sponsor: Pfizer

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.

Study Timeline

• Study Start: 2004-06
• Study Completion: 2004-07
• Status Verified: 2008-04
• Study First Submitted: 2008-04-01
• Study First Submitted QC: 2008-04-16
• Study First Posted: 2008-04-17
• Last Update Submitted: 2008-04-21
• Last Update Posted: 2008-04-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	parecoxib/valdecoxib	-

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale Pain Intensity (0-100 mm), which was evaluated using the change from baseline	Day 3

Secondary Outcome Measures

Name	Time	Method
Visual Analog Scale Pain Intensity	Day 7
Categorical Pain Intensity	Day 3 and Day 7
Patient pain relief	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	Study endpoint
Dyspepsia	Study endpoint
Adverse events	Day 1, Day 3, and Day 7
Patient Global Evaluation	Day 3 and Day 7

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇦🇷 Buenos Aires, Argentina