Effect of Celecoxib Versus Placebo Before and After Knee Surgery on Overall Use of Analgesics After Surgery

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NCT00633438

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Study Location
Pfizer Investigational Site
Phoenix, Arizona, 85023, United States
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Contact
1-800-718-1021
[email protected]
Related Links

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Arthroscopy
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

Inclusion criteria:

- Diagnosed (or suspected to have) meniscus trauma of the knee requiring ambulatory arthroscopic knee surgery

- Willing to participate in study for 36 hours and come to follow-up visit 7 days post surgery

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


Exclusion criteria:


- Osteoarthritis, inflammatory arthritis, or previous fracture of index joint


- Received acetaminophen or low dose narcotic (vicodin/tylox) within 8 hours of surgery


- Have received oral (4 weeks), intramuscular (2 months), intra-articular (3 months) or
soft-tissue (2 months) injections of corticosteroids of the first dose of study
medication or intra-artcular injections of hyaluronic acid in the index joint within 9
months of the first dose of study medication

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ArthroscopyEffect of Celecoxib Versus Placebo Before and After Knee Surgery on Overall Use of Analgesics After Surgery
NCT00633438
  1. Phoenix, Arizona
  2. St. Petersburg, Florida
  3. Baltimore, Maryland
  4. Timonium, Maryland
  5. Springfield, Massachusetts
  6. Springfield, Massachusetts
  7. Springfield, Massachusetts
  8. Springfield, Massachusetts
  9. Springfield, Missouri
  10. Columbia, South Carolina
  11. Columbia, South Carolina
  12. Columbia, South Carolina
  13. Orangeburg, South Carolina
  14. Johnson City, Tennessee
  15. San Antonio, Texas
  16. San Antonio, Texas
  17. San Antonio, Texas
  18. San Antonio, Texas
ALL GENDERS
18 Years+
years
MULTIPLE SITES
ArthroscopyEffect of Celecoxib Versus Placebo Before and After Knee Surgery on the Overall Use of Analgesics After Surgery
NCT00633386
  1. Phoenix, Arizona
  2. St. Petersburg, Florida
  3. Baltimore, Maryland
  4. Springfield, Massachusetts
  5. Springfield, Missouri
  6. Columbia, South Carolina
  7. Johnson City, Tennessee
  8. San Antonio, Texas
  9. Charlottesville, Virginia
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Effect of Celecoxib Versus Placebo Before and After Knee Surgery on Overall Use of Analgesics After Surgery
Official Title  ICMJE A Double-Blind, Placebo-Controlled, Randomized Comparison Study of the Efficacy of Celebrex 400 mg Single Dose Pre and Celebrex 200 mg Post Ambulatory Arthroscopic Knee Surgery for Total Analgesic Use After Surgery
Brief Summary To compare total analgesic use at 24 hours after arthroscopic knee surgery in celecoxib-treated versus placebo-treated patients
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Arthroscopy
Intervention  ICMJE
  • Other: Placebo
    Matched oral capsule administered 1 hour prior to surgery and matched oral capsule administered post surgery as needed
  • Drug: Celecoxib
    400 mg oral capsule as single dose administered 1 hour prior to surgery and 200 mg oral capsule as single dose administered post surgery as needed
Study Arms  ICMJE
  • Placebo Comparator: B
    Intervention: Other: Placebo
  • Experimental: A
    Intervention: Drug: Celecoxib
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
Actual Enrollment  ICMJE
 (submitted: March 4, 2008)		204
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

Inclusion criteria:

  • Diagnosed (or suspected to have) meniscus trauma of the knee requiring ambulatory arthroscopic knee surgery
  • Willing to participate in study for 36 hours and come to follow-up visit 7 days post surgery

Exclusion Criteria:

Exclusion criteria:

  • Osteoarthritis, inflammatory arthritis, or previous fracture of index joint
  • Received acetaminophen or low dose narcotic (vicodin/tylox) within 8 hours of surgery
  • Have received oral (4 weeks), intramuscular (2 months), intra-articular (3 months) or soft-tissue (2 months) injections of corticosteroids of the first dose of study medication or intra-artcular injections of hyaluronic acid in the index joint within 9 months of the first dose of study medication
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00633438
Other Study ID Numbers  ICMJE A3191067
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2009

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