Morphine-Sparing Effect And Safety Of Parecoxib Administered Intravenously For The Treatment Of Postoperative Pain
NCT00143169
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- Undergo gynecological or orthopedic surgery under epidural anesthesia
- A previous history of intolerance or hypersensitivity to any NSAID, cyclooxygenase-2
selective inhibitors, sulphonamides, or any of the excipients of parecoxib.
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Descriptive Information | ||||
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Brief Title ICMJE | Morphine-Sparing Effect And Safety Of Parecoxib Administered Intravenously For The Treatment Of Postoperative Pain | |||
Official Title ICMJE | A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study Of Morphine-Sparing Effect And Safety Of Parecoxib Administered Intravenously For The Treatment Of Postoperative Pain Following Orthopedic Or Gynecological Surgery | |||
Brief Summary | To validate the morphine-sparing effect and safety of parecoxib administered intravenously for the treatment of Chinese subjects with postoperative pain following gynecological or orthopedic surgery. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment | |||
Condition ICMJE | Pain, Postoperative | |||
Intervention ICMJE | Drug: Parecoxib and placebo | |||
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 | Completed | |||
Enrollment ICMJE | 220 | |||
Original Enrollment ICMJE | Same as current | |||
Study Completion Date ICMJE | June 2005 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | China | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00143169 | |||
Other Study ID Numbers ICMJE | A3481004 | |||
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 |
| |||
PRS Account | Pfizer | |||
Verification Date | November 2005 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |