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NCT03770091 · ClinicalTrials.gov registry record · Phase 3
Impact of TheraWorx Foam on Symptom Relief in Thumb Arthritis
A Phase 3 study, sponsored by John Fowler.
- Completed
- Registry status
- Phase 3
- Development phase
- 40
- Enrollment target
NCT03770091: Completed Phase 3 study, sponsored by John Fowler.
NCT03770091 is a Phase 3 study that has completed, run by John Fowler. The registered enrollment target is 40 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03770091, a Phase 3 study, has completed, sponsored by John Fowler.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 40 participants
- Enrollment target
Study Summary
Thumb carpometacarpal osteoarthritis (CMC OA) affects up to 33% of people over the age of 40, which leads to inflammation, pain, and weakness of the CMC joint. Treatment modalities are both conservative and surgical with surgical options including osteotomy, bone excision, ligament reconstruction, and various prosthetic implants. The conservative treatment options, however, are limited to NSAIDs and bracing or steroid injections. Advances in topical therapies have the potential to deliver focused treatment to the CMC joint. Novel treatment of inflammation can potentially reduce inflammation and pain associated with progressing osteoarthritis. Theraworx Relief is an FDA registered foam that has theoretical impact on inflammation reduction in human subjects treated with the topical foam.
Primary Outcome
patient rated pain on scale of 0-10 (0 no pain and 10 maximum pain). The mean score at 2 weeks is reported, not the change from baseline.
Interventions
- DRUG Placebo
- DRUG Theraworx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2018-12-21 |
| Est. Completion | 2020-08-01 |
| Phase | Phase 3 |
What the finished NCT03770091 record still lists
NCT03770091 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03770091 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03770091 about?
NCT03770091 is a clinical study titled "Impact of TheraWorx Foam on Symptom Relief in Thumb Arthritis". Thumb carpometacarpal osteoarthritis (CMC OA) affects up to 33% of people over the age of 40, which leads to inflammation, pain, and weakness of the CMC joint. Treatment modalities are both conservative and surgical with surgical options including osteotomy, bone excision, ligament reconstruction, a...
What is the current status of trial NCT03770091?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 40 participants. The study started on 2018-12-21. Estimated completion is 2020-08-01.
What interventions are being tested in trial NCT03770091?
The interventions under investigation include: Placebo (DRUG), Theraworx (DRUG).
Who is sponsoring clinical trial NCT03770091?
This trial is sponsored by John Fowler, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03770091's enrollment target sits among peer trials
40 1878th of 2000 higher than 103 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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