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NCT04231318 · ClinicalTrials.gov registry record · Phase 3
Study of Cingal® and Triamcinolone Hexacetonide for the Relief of Knee Osteoarthritis Pain
A Phase 3 study, sponsored by Anika Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 231
- Enrollment target
NCT04231318: Completed Phase 3 study, sponsored by Anika Therapeutics.
NCT04231318 is a Phase 3 study that has completed, run by Anika Therapeutics. The registered enrollment target is 231 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04231318, a Phase 3 study, has completed, sponsored by Anika Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 231 participants
- Enrollment target
Study Summary
This is a multi-center, randomized, double-blind, parallel group, placebo controlled trial to compare the safety and effectiveness of a single injection of Cingal® to a single injection of Triamcinolone Hexacetonide (TH) to achieve pain relief and other symptoms of osteoarthritis of the knee.
Primary Outcome
The change from Baseline in knee pain post-treatment as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score comparing the Cingal arm to the TH arm, the Cingal arm to the Placebo arm, and the TH arm to the Placebo arm. WOMAC Pain is a validated 100 mm visual analog scale (VAS) from 0 mm = No Pain to 100 mm = Highest Pain Level. A negative value for the change from Baseline indicates improvement in the WOMAC Pain Score, i.e. less pain post-treatment. A
Interventions
- DRUG Placebo
- DRUG Cingal
- DRUG Triamcinolone Hexacetonide (TH)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 231 participants |
| Start Date | 2020-09-11 |
| Est. Completion | 2022-05-16 |
| Phase | Phase 3 |
What the finished NCT04231318 record still lists
NCT04231318 is an interventional study that assigns participants to a tested intervention. The registered 231 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04231318 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04231318 about?
NCT04231318 is a clinical study titled "Study of Cingal® and Triamcinolone Hexacetonide for the Relief of Knee Osteoarthritis Pain". This is a multi-center, randomized, double-blind, parallel group, placebo controlled trial to compare the safety and effectiveness of a single injection of Cingal® to a single injection of Triamcinolone Hexacetonide (TH) to achieve pain relief and other symptoms of osteoarthritis of the knee.
What is the current status of trial NCT04231318?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 231 participants. The study started on 2020-09-11. Estimated completion is 2022-05-16.
What interventions are being tested in trial NCT04231318?
The interventions under investigation include: Placebo (DRUG), Cingal (DRUG), Triamcinolone Hexacetonide (TH) (DRUG).
Who is sponsoring clinical trial NCT04231318?
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 NCT04231318's enrollment target sits among peer trials
231 1300th of 2000 higher than 697 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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