The Effects of Celecoxib on Bone Ingrowth

NCT00585156

Last updated date
Study Location
Veteran Affairs (VA) Medical Center
Salt Lake City, Utah, 84148, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Bone Ingrowth, Pain
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-95 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male VA bilateral TKA patients 18 years or older with primary OA diagnosis

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


- Patients with osteoporosis, hypersensitivity to Celebrex, allergy to tetracycline,
Sulfonamides, patient with asthma, urticaria, or allergic-type reactions to aspirin or
NSAIDs.


- Patients who have had CABG.


- Patients with a history of peptic ulcer disease, duodenal ulcers.


- Female patients and patients diagnosed with unstable hypertension or hypotensive, with
serum creative levels above 1.8-2.0 or diagnosed with severe renal disease.

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Bone Ingrowth, PainThe Effects of Celecoxib on Bone Ingrowth
NCT00585156
  1. Salt Lake City, Utah
Male
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE The Effects of Celecoxib on Bone Ingrowth
Official Title  ICMJE The Effects of Celecoxib on Bone Ingrowth in Porous Coated Titanium Ceramic Implants in Humans
Brief Summary The purpose of this study is to evaluate the effect of Celebrex on bone growth into porous coated implants, following postoperative total knee arthroplasty administration of Celebrex for pain relief.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE
  • Bone Ingrowth
  • Pain
Intervention  ICMJE Drug: Celecoxib
Twelve hours prior to their first total knee surgery, patients will need to take an oral dose of Celebrex, 1 pill of 200mg. Following the patient's first total knee surgery, they will continue taking oral doses of Celebrex, 1 pill of 200 mg every twenty-four hours (200mg/day) for a two-week period.
Other Name: Celebrex
Study Arms  ICMJE Experimental: Arm #1
Celebrex treatment group
Intervention: Drug: Celecoxib
Publications *

*   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 Terminated
Actual Enrollment  ICMJE
 (submitted: January 2, 2008)
9
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2008
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male VA bilateral TKA patients 18 years or older with primary OA diagnosis

Exclusion Criteria:

  • Patients with osteoporosis, hypersensitivity to Celebrex, allergy to tetracycline, Sulfonamides, patient with asthma, urticaria, or allergic-type reactions to aspirin or NSAIDs.
  • Patients who have had CABG.
  • Patients with a history of peptic ulcer disease, duodenal ulcers.
  • Female patients and patients diagnosed with unstable hypertension or hypotensive, with serum creative levels above 1.8-2.0 or diagnosed with severe renal disease.
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Ages  ICMJE 18 Years to 95 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
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 NCT00585156
Other Study ID Numbers  ICMJE IIR#2005-0300
IIR#2005-0300
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Utah
Study Sponsor  ICMJE University of Utah
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Roy Bloebaum, Ph.D.Research Professor, Orthopedic Surgery
PRS Account University of Utah
Verification Date March 2016

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