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NCT01272830 · ClinicalTrials.gov registry record · Phase 2
Double-Blinded Clinical Trial Using Apatone®B for Symptomatic Postoperative Total Joint Replacements
A Phase 2 study of Synovitis and Edematous, sponsored by IC-MedTech Corporation.
- Completed
- Registry status
- Phase 2
- Development phase
- 57
- Enrollment target
- 1
- Study location
NCT01272830: Completed Phase 2 study of Synovitis and Edematous, sponsored by IC-MedTech Corporation.
NCT01272830 is a Phase 2 study of Synovitis and Edematous that has completed, run by IC-MedTech Corporation. The registered enrollment target is 57 participants, below the 255-participant average among 4 other Synovitis trials with a reported enrollment target (78% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01272830, a Phase 2 study of Synovitis and Edematous, has completed, sponsored by IC-MedTech Corporation.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 57 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Pain Visual Analog Scale (VAS) Scale range (0-100) A higher VAS score indicate worse knee pain
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Apatone®B
Study Locations (1)
Ohio
- Summa Health System - Akron
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2010-10 |
| Est. Completion | 2015-12 |
| Phase | Phase 2 |
What the finished NCT01272830 record still lists
NCT01272830 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, below the 255-participant average among 4 other Synovitis trials with a reported enrollment target (78% lower).
The record links to 4 conditions, with Synovitis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01272830 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT01272830 about?
NCT01272830 is a clinical study titled "Double-Blinded Clinical Trial Using Apatone®B for Symptomatic Postoperative Total Joint Replacements". 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.
What is the current status of trial NCT01272830?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 57 participants. The study started on 2010-10. Estimated completion is 2015-12.
What conditions does trial NCT01272830 study?
This clinical trial studies the following conditions: Synovitis, Edematous, Foreign Body Reaction, Osteolysis.
What interventions are being tested in trial NCT01272830?
The interventions under investigation include: Placebo (DRUG), Apatone®B (DRUG).
Who is sponsoring clinical trial NCT01272830?
This trial is sponsored by IC-MedTech Corporation, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01272830 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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