Efficacy And Safety Of Parecoxib IV/IM 40 Mg Vs Placebo Following Sub Muscular Breast Augmentation - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00435747

Purpose

The present study aims to compare the pre-emptive analgesic efficacy of parecoxib 40 mg IV/IM versus placebo on reducing postoperative acute pain following submuscular breast augmentation. Additionally this study is being conducted to evaluate the safety and tolerability of parecoxib in this kind of procedure.

Condition	Intervention	Phase
Pain, Postoperative	Drug: PARECOXIB SODIUM	Phase IV

Drug Information available for: Parecoxib Parecoxib sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	A Double-Blind Comparative Multicenter Study Of The Efficacy And Safety Of Parecoxib IV/IM 40 Mg Vs Placebo On Reducing Opioids Consumption Following Sub Muscular Breast Augmentation Surgery

Further study details as provided by Pfizer:

Primary Outcome Measures:

To evaluate the opioid-sparing effect of parecoxib 40 mg IV/IM compared to placebo in pre emptive analgesia in patients submitted to sub muscular breast augmentation during the first 24 hours after the first dose of study drug.

Secondary Outcome Measures:

To evaluate the efficacy, safety and tolerability of parecoxib 40 mg IV/IM compared to placebo used to reduce pain following sub muscular breast augmentation in terms of pain intensity
To evaluate the efficacy, safety and tolerability of parecoxib 40 mg IV/IM compared to placebo used to reduce pain following sub muscular breast augmentation in terms of global evaluation of study medication
To evaluate the efficacy, safety and tolerability of parecoxib 40 mg IV/IM compared to placebo used to reduce pain following sub muscular breast augmentation in terms of vital signs
To evaluate the efficacy, safety and tolerability of parecoxib 40 mg IV/IM compared to placebo used to reduce pain following sub muscular breast augmentation in terms of coagulation tests
To evaluate the efficacy, safety and tolerability of parecoxib 40 mg IV/IM compared to placebo used to reduce pain following sub muscular breast augmentation in terms of adverse events

Estimated Enrollment:

150

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Female patients of any ethnic origin aged 18 years or over.
The patient is post-menopausal, surgically sterile, or using adequate contraception, not lactating, with a negative urine pregnancy test at screening, prior to administration of study medication.
The patient's preoperative health is graded as a class I or II according to the ASA physical status classification and on the basis of medical history and physical examination.

Exclusion Criteria:

The patient has significant clinical signs and symptoms suggestive of renal or hepatic morbid conditions
The patient has a history of clinically significant hypersensitivity to any NSAIDs, cyclooxygenase inhibitors, analgesics or sulfa medications which has a cross sensitivity to the medications used in this study.
The patient used analgesics or other agents (antidepressants, sedating antihistamines or other sedatives, muscle relaxants, narcotics, or corticosteroids) during the four hours preceding the procedure that could confound the analgesic responses.
Subjects with a history of established ischemic heart disease (e.g. myocardial infarction, stable angina, unstable angina), peripheral arterial disease and/or cerebrovascular disease (e.g. ischemic or hemorrhagic stroke, transient ischemic attack), as well as subjects with previous revascularization procedure to coronary, carotid, cerebral, renal, aortic or peripheral arterial vasculature

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00435747

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	A3481100
Study First Received:	February 13, 2007
Last Updated:	November 1, 2007
ClinicalTrials.gov Identifier:	NCT00435747 History of Changes
Health Authority:	Peru: General Directorate of Pharmaceuticals, Devices, and Drugs

Study placed in the following topic categories:

Anti-Inflammatory Agents
Signs and Symptoms
Parecoxib
Postoperative Complications
Analgesics, Non-Narcotic
Cyclooxygenase Inhibitors

Anti-Inflammatory Agents, Non-Steroidal
Pain
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Pain, Postoperative

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Parecoxib
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Pain
Enzyme Inhibitors
Pharmacologic Actions
Signs and Symptoms
Pathologic Processes

Postoperative Complications
Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Central Nervous System Agents
Pain, Postoperative

ClinicalTrials.gov processed this record on May 07, 2009