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Trial record 1 of 1 for:    NCT00633438
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Effect of Celecoxib Versus Placebo Before and After Knee Surgery on Overall Use of Analgesics After Surgery

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ClinicalTrials.gov Identifier: NCT00633438
Recruitment Status : Completed
First Posted : March 12, 2008
Last Update Posted : February 21, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

Tracking Information
First Submitted Date  ICMJE March 4, 2008
First Posted Date  ICMJE March 12, 2008
Last Update Posted Date February 21, 2021
Study Start Date  ICMJE January 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: March 4, 2008)		 Total analgesic use (hydrocodone bitartrate 5 mg/acetaminophen 500 mg [HC/APAP]) after surgery [ Time Frame: 24 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 4, 2008)
  • Patient Assessment of Pain, according to visual analogue scale, after surgery at rest and flexion [ Time Frame: 1, 2, 6, 8, 10, 12, 24, 36 hours ]
  • Time to analgesic use after surgery [ Time Frame: 1, 2, 6, 8, 10, 12, 24, 36 hours ]
  • Number and percentage of patients taking HC/APAP after surgery [ Time Frame: 1, 2, 6, 8, 10, 12, 24, 36 hours ]
  • Adverse events [ Time Frame: Day 7 ]
  • Physical exam [ Time Frame: Day 7 ]
  • Vital signs [ Time Frame: Day 7 ]
  • Laboratory evaluation [ Time Frame: Day 7 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
Study Sponsor  ICMJE Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date February 2021

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