Trial · NCT05152173
Efficacy, Safety, and Tolerability, of EN3835 vs Placebo in the Treatment of Plantar Fibromatosis
NCT05152173, Phase 2, Completed, Endo USA Inc., a Keenova Therapeutics Company
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy, Safety, and Tolerability, of EN3835 vs Placebo in the Treatment of Plantar Fibromatosis. Trials, record NCT05152173. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05152173
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy, Safety, and Tolerability, of EN3835 vs Placebo in the Treatment of Plantar Fibromatosis
- NCT number
- NCT05152173
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 176 participants, actual
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics Company
- Conditions
- Plantar Fibromatosis
- Interventions
- EN3835, Placebo
- First posted
- 2021-12-09
- Last updated
- 2026-03-27
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to Day 57 in the Foot Function Index (FFI) Pain Subscale Score | Baseline (Day 1), Day 57 | FFI pain subscale consisted of 9 items which were scored on a scale of 0 ("None") to 4 ("Extreme") with a total score ranging from 0 to 36. Lower scores indicated better foot function, while higher scores reflected greater impairment. |
| Secondary | Change From Baseline to Day 57 in the FFI Total Combined (Pain and Difficulty) Score | Baseline (Day 1), Day 57 | The FFI pain subscale consisted of 9 items which were scored on a scale of 0 ("None") to 4 ("Extreme") with a total score ranging from 0 to 36. The FFI difficulty subscale consisted of 9 items which were scored on a scale of 0 ("No difficulty") to 4 ("A lot of difficulty") with a total score ranging from 0 to 36. The Total Combined score of pain and difficulty comprised scores of answered items in each subscale with a maximum total score range of 0 to 72. Lower scores indicated better foot function, while higher scores reflected greater impairment. |
| Secondary | Percentage of Participants With a Response of "Minimal Improvement", "Much Improvement" or "Very Much Improvement" (Responders) in the Clinician Global Impression of Change Scale | Day 57 | The responder (by foot/feet) was defined as a participant with a response of "Minimal Improvement", "Much Improvement" or "Very Much Improvement" in the CGIC Scale. All participants who withdrew early from the study were considered as non-responders. If participant was treated for both feet, then the assessment could be combined at participant level using worst case approach, if one foot response was recorded as 'Minimal Improvement' and 'Very Much Improvement' in another foot, then response was considered as 'Minimal Improvement'. |
| Secondary | Change From Baseline to Day 57 in the Nodular Hardness of the Treated Nodules by Durometer Measurement | Baseline (Day 1), Day 57 | A durometer was used to measure the hardness of treated nodules, on a scale ranging from 0 to 100. Higher scores indicated a greater hardness. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05152173
GET https://conductscience.org/api/trials/v1/NCT05152173/registered