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The Effects of Celecoxib on Bone Ingrowth

This study has been terminated.
(New clinical finding with Celebrex and cardiac concerns.)
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
roy bloebaum, University of Utah
ClinicalTrials.gov Identifier:
NCT00585156
First received: December 26, 2007
Last updated: September 26, 2011
Last verified: September 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Bone Ingrowth
Pain
 Drug: Celecoxib
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Effects of Celecoxib on Bone Ingrowth in Porous Coated Titanium Ceramic Implants in Humans

Resource links provided by NLM:

Drug Information available for: Celecoxib
U.S. FDA Resources

Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Bone Ingrowth [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain Score [ Time Frame: 10 days postoperative ] [ Designated as safety issue: No ]

Enrollment: 9
Study Start Date: June 2008
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm #1
Celebrex treatment group
 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

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00585156

Locations
United States, Utah
Veteran Affairs (VA) Medical Center
Salt Lake City, Utah, United States, 84148
Sponsors and Collaborators
University of Utah
Pfizer
Investigators
Principal Investigator: Roy Bloebaum, Ph.D. Research Professor, Orthopedic Surgery
  More Information

Publications:

Responsible Party: roy bloebaum, Research Professor, University of Utah
ClinicalTrials.gov Identifier: NCT00585156     History of Changes
Other Study ID Numbers: IIR#2005-0300, IIR#2005-0300
Study First Received: December 26, 2007
Last Updated: September 26, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Utah:
Celebrex, Bone Ingrowth, Pain relief

Additional relevant MeSH terms:
Celecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Central Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 19, 2013