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

NCT00435747

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Postoperative Pain
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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 factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Advanced Information
Descriptive Information
Brief Title  ICMJE Efficacy And Safety Of Parecoxib IV/IM 40 Mg Vs Placebo Following Sub Muscular Breast Augmentation
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Pain, Postoperative
Intervention  ICMJE Drug: PARECOXIB SODIUM
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: March 13, 2012)
0
Original Enrollment  ICMJE
 (submitted: February 13, 2007)
150
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00435747
Other Study ID Numbers  ICMJE A3481100
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP