Trial · NCT06151197
Study to Assess EN3835 in the Treatment of Plantar Fibromatosis (Also Known as Ledderhose Disease)
NCT06151197, Phase 3, Completed, Endo USA Inc., a Keenova Therapeutics Company
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study to Assess EN3835 in the Treatment of Plantar Fibromatosis (Also Known as Ledderhose Disease). Trials, record NCT06151197. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06151197
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Assess EN3835 in the Treatment of Plantar Fibromatosis (Also Known as Ledderhose Disease)
- NCT number
- NCT06151197
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 436 participants, actual
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics Company
- Conditions
- Plantar Fibromatosis, Ledderhose Disease
- Interventions
- EN3835, Placebo
- First posted
- 2023-11-30
- Last updated
- 2026-10-14
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change from Baseline to Week 12 in the Weekly Mean of the Average Daily (24-hour) Pain (ADP) Score as Measured on the Pain Intensity Numeric Rating Scale (NRS) | Baseline, Week 12 | |
| Secondary | Change from Baseline in the Foot Function Index (FFI) Difficulty Subscale Score | Baseline, up to Day 85 | |
| Secondary | Change from Baseline in the FFI Activity Limitation Subscale Score | Baseline, up to Day 85 | |
| Secondary | Change from Baseline in the FFI Pain Subscale Score | Baseline, up to Day 85 | |
| Secondary | Change from Baseline in the FFI Total Score | Baseline, up to Day 85 | |
| Secondary | Number of Participants That Used Rescue Analgesic Medication | Up to Day 85 | |
| Secondary | Amount of (milligrams [mg]) Rescue Analgesic Medication Used | Up to Day 85 | |
| Secondary | Patient Global Impression of Change (PGIC) Foot Pain Score | Up to Day 85 | |
| Secondary | Patient Global Impression of Severity (PGIS) Score | Up to Day 85 | |
| Secondary | Clinician Global Impression of Change (CGIC) Score | Up to Day 85 |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes0
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/NCT06151197
GET https://conductscience.org/api/trials/v1/NCT06151197/registered