Clinical trial NCT00435747: Efficacy And Safety Of Parecoxib IV/IM 40 Mg Vs Placebo Following Sub Muscular Breast Augmentation
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Pain, Postoperative
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-02-15
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: 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 outcomes:
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: