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NCT00653432 · ClinicalTrials.gov registry record · NA
Safety and Effectiveness of Monovisc® Injection for Osteoarthritis of the Knee
A NA study, sponsored by Anika Therapeutics.
- Completed
- Registry status
- NA
- Development phase
- 369
- Enrollment target
NCT00653432: Completed NA study, sponsored by Anika Therapeutics.
NCT00653432 is a NA study that has completed, run by Anika Therapeutics. The registered enrollment target is 369 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00653432, a NA study, has completed, sponsored by Anika Therapeutics.
- COMPLETED
- Registry status
- NA
- Development phase
- 369 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether intra-articular injection of Monovisc® hyaluronic acid provides symptomatic relief of osteoarthritis of the knee.
Primary Outcome
The primary endpoint measures the percentage of subjects (Monovisc vs. saline) who achieved \>= a 40% improvement (reduction) in the WOMAC Pain Score and show at least 15 mm improvement (reduction) in the WOMAC Pain Score from baseline through 12 weeks. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score is a validated scale from 0 to 100 mm, where a higher score is equal to a higher pain level. The primary endpoint uses the ITT population that has data availabl
Interventions
- OTHER Saline
- DEVICE Monovisc®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 369 participants |
| Start Date | 2008-01 |
| Est. Completion | 2010-02 |
| Phase | NA |
What the finished NCT00653432 record still lists
NCT00653432 is an interventional study that assigns participants to a tested intervention. The registered 369 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 2 interventions - of which Saline is the first listed.
NCT00653432 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00653432 about?
NCT00653432 is a clinical study titled "Safety and Effectiveness of Monovisc® Injection for Osteoarthritis of the Knee". The purpose of this study is to determine whether intra-articular injection of Monovisc® hyaluronic acid provides symptomatic relief of osteoarthritis of the knee.
What is the current status of trial NCT00653432?
This trial is currently completed. It is a NA study. The enrollment target is 369 participants. The study started on 2008-01. Estimated completion is 2010-02.
What interventions are being tested in trial NCT00653432?
The interventions under investigation include: Saline (OTHER), Monovisc® (DEVICE).
Who is sponsoring clinical trial NCT00653432?
This trial is sponsored by Anika Therapeutics, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00653432's enrollment target sits among peer trials
369 281st of 2000 higher than 1,718 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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