Morphine-Sparing Effect And Safety Of Parecoxib Administered Intravenously For The Treatment Of Postoperative Pain

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NCT00143169

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Study Location
Pfizer Investigational Site
Guangzhou, Guangdong, 510080, China
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Contact
1-800-718-1021
[email protected]
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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

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[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pain, Postoperative
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Undergo gynecological or orthopedic surgery under epidural anesthesia

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


- 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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Pain, PostoperativeMorphine-Sparing Effect And Safety Of Parecoxib Administered Intravenously For The Treatment Of Postoperative Pain
NCT00143169
  1. Guangzhou, Guangdong
  2. Shenyang, Liaoning
  3. Qingdao, Shandong
  4. Beijing,
  5. Beijing,
  6. Beijing,
  7. Shanghai,
  8. Shanghai,
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  1. Adelaide, South Australia
  2. Hong Kong,
  3. Shatin, New Territories,
  4. Seoul,
  5. Seoul,
  6. Seoul,
  7. Seoul,
  8. Cheras, Kuala Lumpur
  9. Kuala Lumpur, Wilayah Persekutuan
  10. Kuala Lumpur, Wilayah Persekutuan
  11. Auckland,
  12. Christchurch,
  13. Wellington,
  14. Manila,
  15. Quezon City,
  16. Quezon,
  17. Singapore,
  18. Kaohsiung,
  19. Keelung,
  20. Taipei,
  21. Bangkok,
  22. Bangkok,
  23. Bangkok,
  24. Bangkok,
ALL GENDERS
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Advanced Information
Descriptive Information
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
 (submitted: August 31, 2005)		220
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE June 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Undergo gynecological or orthopedic surgery under epidural anesthesia

Exclusion Criteria:

  • A previous history of intolerance or hypersensitivity to any NSAID, cyclooxygenase-2 selective inhibitors, sulphonamides, or any of the excipients of parecoxib.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
Study Director:Pfizer CT.gov Call CenterPfizer
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