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

Last updated on October 4, 2018

FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
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

NCT00435747
Pfizer
Withdrawn
Efficacy And Safety Of Parecoxib IV/IM 40 Mg Vs Placebo Following Sub Muscular Breast Augmentation

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Efficacy And Safety Of Parecoxib IV/IM 40 Mg Vs Placebo Following Sub Muscular Breast Augmentation
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
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Pain, Postoperative
Drug: PARECOXIB SODIUM
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
Not Provided
Not Provided

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00435747
A3481100
Not Provided
Not Provided
Not Provided
Not Provided
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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