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Trial record 1 of 1 for:    apatone
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Double-Blinded Clinical Trial Using Apatone®B for Symptomatic Postoperative Total Joint Replacements (Apatone-B)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01272830
Recruitment Status : Completed
First Posted : January 10, 2011
Results First Posted : January 31, 2018
Last Update Posted : January 31, 2018
Sponsor:
Collaborators:
Summa Health System
Crystal Clinic Orthopaedic Center LLC
Information provided by (Responsible Party):
IC-MedTech Corporation

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Edematous
Synovitis
Foreign Body Reaction
Osteolysis
Interventions: Drug: Placebo
Drug: Apatone®B

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 57 subjects were consented to participate.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

Following consenting, 6 subjects did not meet the study inclusion/exclusion criteria, thus never received the study drug.

1 - Abnormal Liver Panel: very low Hemoglobin/Hematocrit levels

1 - Glucose-6-phosphate dehydrogenase (G6PD) deficiency

3 - X-rays revealed loose or mal-positioned component(s)

1 - Prescribed steroids prior to study drug


Reporting Groups
  Description
Oral Apatone®B

An amalgam of Vitamins C & K3

Apatone®B: Two capsules taken twice daily with meals

Placebo

Oral capsule of similar appearance and taste without Apatone®B

Placebo: Two capsules taken twice daily with meals


Participant Flow:   Overall Study
    Oral Apatone®B   Placebo
STARTED   25   26 
COMPLETED   17   21 
NOT COMPLETED   8   5 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Oral Apatone®B

An amalgam of Vitamins C & K3

Apatone®B: Two capsules taken twice daily with meals

Placebo

Oral capsule of similar appearance and taste without Apatone®B

Placebo: Two capsules taken twice daily with meals

Total Total of all reporting groups

Baseline Measures
   Oral Apatone®B   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 17   21   38 
Age 
[Units: Years]
Mean (Standard Deviation)
 62.1  (9.5)   65.4  (9.6)   63.9  (9.7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      9  52.9%      12  57.1%      21  55.3% 
Male      8  47.1%      9  42.9%      17  44.7% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   17   21   38 
Weight 
[Units: Kilograms]
Mean (Standard Deviation)
 96.7  (20.4)   100  (16.8)   99  (18.5) 
Height 
[Units: Centimeters]
Mean (Standard Deviation)
 171.7  (9.9)   169.8  (8.6)   170.6  (9.2) 
Time elapsed since TKA [1] 
[Units: Years]
Mean (Standard Deviation)
 2.5  (1.9)   4.0  (3.3)   3.3  (2.9) 
[1] TKA - Total Knee Arthroplasty
Initial Pain Visual Analog Scale (VAS) [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 57  (24.1)   46.8  (24.9)   51.4  (25.1) 
[1]

VAS Scale range (0-100 )

Higher VAS score indicate worst knee pain.



  Outcome Measures

1.  Primary:   Pain Visual Analog Scale (VAS)   [ Time Frame: 13-weeks ]

2.  Secondary:   Surrogate Endpoint Markers (SEBs)   [ Time Frame: 13 weeks ]

3.  Secondary:   TGFBeta Levels   [ Time Frame: Baseline and 13 Weeks ]

4.  Secondary:   Deoxypyridinoline Levels   [ Time Frame: Baseline and 13 Weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Thomas Bear, MD
Organization: Clinic Orthopaedic Center
phone: 330-375-3906
e-mail: kovacikm@summahealth.org



Responsible Party: IC-MedTech Corporation
ClinicalTrials.gov Identifier: NCT01272830     History of Changes
Other Study ID Numbers: Summa-09136
First Submitted: December 17, 2010
First Posted: January 10, 2011
Results First Submitted: July 19, 2017
Results First Posted: January 31, 2018
Last Update Posted: January 31, 2018