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 4TerminatedNCT00660855

Pfizer4 enrolled

Overview

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

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

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pain, Post Surgical

Interventions

parecoxib/valdecoxibDRUG

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.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (2)

Pfizer Investigational Site

Buenos Aires, Argentina

Pfizer Investigational Site

Buenos Aires, Argentina

Outcomes

Primary Outcomes

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

Time frame: Day 3

Secondary Outcomes

Visual Analog Scale Pain Intensity

Time frame: Day 7

Categorical Pain Intensity

Time frame: Day 3 and Day 7

Patient pain relief

Time frame: 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

Dyspepsia

Time frame: Study endpoint

Adverse events

Time frame: Day 1, Day 3, and Day 7

Patient Global Evaluation

Time frame: Day 3 and Day 7

Data from ClinicalTrials.gov

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