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
| Sponsors |
Lead Sponsor: IC-MedTech Corporation Collaborator:
Summa Health System
|
||||||||
|---|---|---|---|---|---|---|---|---|---|
| Source | IC-MedTech Corporation | ||||||||
| Brief Summary | 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. |
||||||||
| Detailed Description | 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. |
||||||||
| Overall Status | Completed | ||||||||
| Start Date | October 2010 | ||||||||
| Completion Date | December 2015 | ||||||||
| Primary Completion Date | December 2014 | ||||||||
| Phase | Phase 2 | ||||||||
| Study Type | Interventional | ||||||||
| Primary Outcome |
|
||||||||
| Secondary Outcome |
|
||||||||
| Enrollment | 57 | ||||||||
| Condition | |||||||||
| Intervention |
Intervention Type: Drug Intervention Name: Placebo Description: Two capsules taken twice daily with meals Arm Group Label: Placebo Intervention Type: Drug Intervention Name: Apatone®B Description: Two capsules taken twice daily with meals Arm Group Label: oral Apatone®B |
||||||||
| Eligibility |
Criteria:
Inclusion Criteria: - Postoperative Total joint replacement with osteoarthritis as the underlying pathology - Proven non-infected symptomatic Total Joint Arthroplasty (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 Toradol); 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 Recommended Daily Allowance (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 Gender: All Minimum Age: 50 Years Maximum Age: 85 Years Healthy Volunteers: Accepts Healthy Volunteers |
||||||||
| Overall Official |
|
||||||||
| Location |
|
||||||||
| Location Countries |
United States |
||||||||
| Verification Date |
October 2017 |
||||||||
| Responsible Party |
Type: Sponsor |
||||||||
| Keywords | |||||||||
| Has Expanded Access | No | ||||||||
| Condition Browse | |||||||||
| Number Of Arms | 2 | ||||||||
| Arm Group |
Label: oral Apatone®B Type: Experimental Description: An amalgam of Vitamins C & K3 Label: Placebo Type: Placebo Comparator Description: Oral capsule of similar appearance and taste without Apatone®B |
||||||||
| Acronym | Apatone-B | ||||||||
| Patient Data | No | ||||||||
| Study Design Info |
Allocation: Randomized Intervention Model: Parallel Assignment Primary Purpose: Treatment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
||||||||