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Double-Blinded Clinical Trial Using Apatone®B for Symptomatic Postoperative Total Joint Replacements (Apatone-B)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Crystal Clinic Orthopaedic Center LLC
Information provided by (Responsible Party):
Thomas Bear, Summa Health System
ClinicalTrials.gov Identifier:
NCT01272830
First received: December 17, 2010
Last updated: November 20, 2013
Last verified: November 2013

December 17, 2010
November 20, 2013
October 2010
December 2013   (final data collection date for primary outcome measure)
Surrogate Endpoint Biomarkers [ Time Frame: 13-weeks ] [ Designated as safety issue: Yes ]
Biochemical, Functional, and Emotional endpoints
Same as current
Complete list of historical versions of study NCT01272830 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Double-Blinded Clinical Trial Using Apatone®B for Symptomatic Postoperative Total Joint Replacements
A Prospective Double-Blinded Clinical Trial Using Apatone®B for Care and Treatment of Proven Non-Infected Symptomatic Postoperative Total Joint Arthroplasties

This research study is being conducted to determine if taking oral (by mouth in pill form) Apatone®B (a combination of Vitamins C and K3) will reduce chronic joint discomfort and improve function of non-infected symptomatic postoperative total joint replacements.

To perform a prospective, randomized, double-blind clinical trial to determine if oral Apatone®B, an amalgam of vitamins C and K3, has a therapeutic efficacy beyond the conservative care customarily used to reduce inflammatory synovitis and to increase the functional capacity of proven non-infected symptomatic postoperative total joint replacements.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Edematous
  • Synovitis
  • Foreign Body Reaction
  • Osteolysis
  • Drug: Placebo
    Two capsules taken twice daily with meals
  • Drug: Apatone®B
    Two capsules taken twice daily with meals
  • Experimental: oral Apatone®B
    An amalgum of Vitamins C & K3
    Intervention: Drug: Apatone®B
  • Placebo Comparator: Placebo
    Oral capsule of similar appearance and taste without Apatone®B
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
December 2013
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Postoperative Total joint replacement with osteoarthritis as the underlying pathology
  • Proven non-infected symptomatic TJA (joint implanted for >12 months post-op)
  • Age (50 to 85 years of age); based on a 10% trim of the age distribution for Summa Health System TJAs (7/1/08-6/30/2009).

Exclusion Criteria:

  • An infection of any kind (prior to, or during the study)
  • Rheumatoid arthritis as the underlying pathology
  • Cortisone injection received <6 months prior to study enrollment
  • Insulin dependent diabetes
  • Diagnosed immunodeficiency
  • On dialysis or have poor kidney function
  • Anti-coagulant medication (e.g., Coumadin or >100mg of Aspirin daily)
  • Anti-seizure medication (e.g., Dilantin)
  • Steroidal medication (e.g., Prednisone, Advair or Symbicort)
  • NSAIDS (e.g., Celebrex or Toadol); a 14-day washout period will be allowed
  • bisphosphonates (e.g., Fosamax, Actonel, Aredia, Didronel, Boniva or Reclast)
  • hormonal therapy (e.g., Estrogen, Progesterone or Testosterone)
  • Cancer (active or in remission)
  • Planned concurrent vitamins exceeding a standard daily multivitamin or exceeding the RDA for individual vitamins if used alone; a 72 hour wash out period will be allowed
  • A glucose-6-phosphate dehydrogenase (G6PD) deficiency
  • Pregnant or lactating; females who are in their reproductive years must have a negative serum pregnancy
  • Lactose intolerant
  • Citric acid intolerant
Both
50 Years to 85 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01272830
Summa-09136
Yes
Thomas Bear, Summa Health System
Summa Health System
Crystal Clinic Orthopaedic Center LLC
Principal Investigator: Thomas F Bear, MD Crystal Clinic Orthopaedic Center LLC
Study Director: Mark W Kovacik, BS Summa Health System
Summa Health System
November 2013

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