EdematousPhase 2Apatone-BNCT01272830

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

A Phase 2 study testing Apatone®B in people with Edematous and Synovitis, run by IC-MedTech Corporation at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 50 to 85 yearsHealthy volunteers can take part
Conditions the study is for: Edematous, Synovitis, Foreign Body Reaction
What is being tested?: Apatone®B
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 57 participants
Where: 1 siteUnited States
Study dates: Oct 2010to Dec 2015
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 to 85 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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).

Who cannot join

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

Show all 18Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Summa Health System
Akron, Ohio, 44310

Other trials in United States

About this study

Official title: A Prospective Double-Blinded Clinical Trial Using Apatone®B for Care and Treatment of Proven Non-Infected Symptomatic Postoperative Total Joint Arthroplasties

Read the 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.

Conditions: Edematous, Synovitis, Foreign Body Reaction, Osteolysis
Being tested: Placebo, Apatone®B
Keywords: total joint arthroplasty, synovitis, ALVAL (Aseptic Lymphocyte-Dominant Vasculitis-Associated Lesion), osteolysis, periprosthetic metallosis
Medical subject headings: Edema, Synovitis, Foreign-Body Reaction, Osteolysis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlaceboDrug
Two capsules taken twice daily with meals
Apatone®BDrug
Two capsules taken twice daily with meals

Study groups in NCT01272830
Study group	Role	What they receive
oral Apatone®B	Experimental	An amalgam of Vitamins C \& K3 Receives: Drug: Apatone®B
Placebo	Placebo comparator	Oral capsule of similar appearance and taste without Apatone®B Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Pain Visual Analog Scale (VAS)
Pain Visual Analog Scale (VAS)
Scale range (0-100) A higher VAS score indicate worse knee pain
Measured: 13-weeks

Secondary outcomes (3)

Surrogate Endpoint Markers (SEBs)
HSS = Hospital for Special Surgery Knee Score , KSS = Knee Society Knee Score.
- Scale range HSS total: 100-90 Excellent; 80-89 Very Good; 70-79 Good; 60-69 Fair; below 60 Poor
- Scale range HSS pain walking: No Pain 15; Mild Pain 10; Moderate Pain 5; Severe Pain 0 (**this is an element of the HSS total)
- Scale range KSS: 80-100 Excellent; 70-79 Good; 60-69 Fair; below 60 Poor
Measured: 13 weeks
TGFBeta Levels
The final synovial aspirates obtained from the symptomatic knee of each subject were analyzed using Quantikine and Pyrilinks-D enzyme-linked immunosorbent assay kits from R\&D Systems (Minneapolis, MN) and Metra Biosystems (Mountain View, CA), respectively.
Lower TGFBeta concentrations represent a better outcome.
Measured: Baseline and 13 Weeks
Deoxypyridinoline Levels
The final synovial aspirates obtained from the symptomatic knee of each subject were analyzed using Quantikine and Pyrlinks-D enzyme-linked immunosorbent assay kits from R\&D Systems(minneapolis, MN) and Metra Biosystems (Mountain View, CA) respectively.
Lower DPD concentrations represent a better outcome
Measured: Baseline and 13 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2010Dec 2015

First posted10 Jan 2011 (estimated)
Study startOct 2010
Primary completionDec 2014
Study completionDec 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for EdematousStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 57 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01272830
Sponsor's protocol ID: Summa-09136
Acronym: Apatone-B
Status last verified: Oct 2017
First submitted: 17 Dec 2010
Last updated: 31 Jan 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 31 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective Double-Blinded Clinical Trial Using Apatone®B for Care and Treatment of Proven Non-Infected Symptomatic Postoperative Total Joint Arthroplasties
ClinicalTrials.gov ID: NCT01272830
Acronym / sponsor ID: Apatone-B / Summa-09136
Conditions: Edematous, Synovitis, Foreign Body Reaction, Osteolysis
Keywords: total joint arthroplasty, synovitis, ALVAL (Aseptic Lymphocyte-Dominant Vasculitis-Associated Lesion), osteolysis, periprosthetic metallosis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 57 participants (actual)
Lead sponsor: IC-MedTech CorporationIndustry (pharma, biotech, devices)
Collaborators: Summa Health System, Crystal Clinic Orthopaedic Center LLC
Study start: Oct 2010
Primary completion: Dec 2014 (actual)
Study completion: Dec 2015 (actual)
First posted: 10 Jan 2011 (estimated)
Results: Posted 31 Jan 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
oral Apatone®B	Experimental	Drug: Apatone®BAn amalgam of Vitamins C \& K3
Placebo	Placebo comparator	Drug: PlaceboOral capsule of similar appearance and taste without Apatone®B

Who may qualify

Ages: 50 to 85 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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).

Key exclusion criteria (18 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PlaceboTwo capsules taken twice daily with meals	Drug	Placebo
Apatone®BTwo capsules taken twice daily with meals	Drug	oral Apatone®B

Primary outcome

Pain Visual Analog Scale (VAS)
Time frame: 13-weeks
Pain Visual Analog Scale (VAS) Scale range (0-100) A higher VAS score indicate worse knee pain

3 secondary outcomes

Surrogate Endpoint Markers (SEBs)
Time frame: 13 weeks
TGFBeta Levels
Time frame: Baseline and 13 Weeks
Deoxypyridinoline Levels
Time frame: Baseline and 13 Weeks

Results and safety

Results posted to the registry on 31 Jan 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Oral Apatone®B	25	17
Placebo	26	21

Primary outcome: Pain Visual Analog Scale (VAS)

Time frame: 13-weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Oral Apatone®B n = 17	Placebo n = 21
Baseline	57 (24.1)	46.8 (24.9)
13 Weeks	39.7 (27.4)	39.1 (29.1)

Oral Apatone®B: p = 0.0063, paired t-test
Placebo: p >0.05, paired t-test

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Oral Apatone®B	1 of 17 (5.9%)	14 of 17 (82.4%)	0 of 17
Placebo	0 of 21 (0%)	7 of 21 (33.3%)	0 of 21

Limitations and caveats (from the sponsor): limited accrual due to meeting stringent study inclusion/exclusion criteria.Stringent inclusion/exclusion created to allow SEB analyses w/o interference or artifacts,\& not due to study drug issues,interaction or limitations.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Thomas F Bear, MD principal investigator

Crystal Clinic Orthopaedic Center LLC

Mark W Kovacik, BS study director

Summa Health System

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Apatone®B in people with Edematous and Synovitis, run by IC-MedTech Corporation at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Visual Analog Scale (VAS) (time frame: 13-weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01272830.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2018; AzTrials last refreshed its copy on 26 Oct 2026.