CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 40 enrolled
Drug / intervention
Theraworx +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03770091
NCT03770091Phase 3Completed

Impact of Theraworx Foam on Pain and Motion and Patient-Reported Outcomes in Thumb Arthritis

John Fowler·interventional·Posted Dec 10, 2018·Updated Jul 14, 2021

In Brief

A Phase 3 clinical trial evaluating Theraworx and Placebo for Arthritis. Completed, enrolled 40 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsArthritis
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedDec 10, 2018
Enrollment StartDec 21, 2018
Primary CompletionJul 30, 2020
Study CompletionAug 1, 2020
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 7.6 years ago

Interventions

Theraworxdrug

Theraworx foam applied to skin and/or compression wrap

Placebodrug

Placebo foam