Trial · NCT07909291
A Three-Arm, Randomized, Placebo-Controlled, Double-Blind Phase 2 Study to Evaluate the Safety and Efficacy of Two Dosage Regimens of a Novel Hydrocortisone Acetate Suppository Formulation Administered With a Proprietary Suppository Applicator in Subjects With Hemorrhoidal Disease
NCT07909291, Phase 2, Not yet recruiting, Cristcot LLC
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Three-Arm, Randomized, Placebo-Controlled, Double-Blind Phase 2 Study to Evaluate the Safety and Efficacy of Two Dosage Regimens of a Novel Hydrocortisone Acetate Suppository Formulation Administered With a Proprietary Suppository Applicator in Subjects With Hemorrhoidal Disease. Trials, record NCT07909291. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07909291
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Three-Arm, Randomized, Placebo-Controlled, Double-Blind Phase 2 Study to Evaluate the Safety and Efficacy of Two Dosage Regimens of a Novel Hydrocortisone Acetate Suppository Formulation Administered With a Proprietary Suppository Applicator in Subjects With Hemorrhoidal Disease
- NCT number
- NCT07909291
- Status
- Not yet recruiting
- Phases
- Phase 2
- Enrollment
- 78 participants, estimated
- Lead sponsor
- Cristcot LLC
- Conditions
- Hemorrhoidal Disease
- Interventions
- hydrocortisone acetate 50 mg, hydrocortisone acetate 75 mg, Placebo, proprietary suppository applicator
- First posted
- 2026-11-02
- Last updated
- 2026-11-02
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Efficacy of 50 mg and 75 mg hydrocortisone acetate suppositories compared to placebo, in the treatment of hemorrhoidal disease, using HDSIM patient reported outcome instrument | 15 days | To evaluate the efficacy of two dosage regimens of hydrocortisone acetate suppository administered with a proprietary suppository applicator (Study Drug) compared to placebo in the treatment of hemorrhoidal disease (HD) at Week 2 (Day 15) versus Baseline (Day 1). The evaluation uses the Hemorrohoid Disease Symptom \& Impact Measure (HDSIM™, Appendix A), a Patient-reported Outcome (PRO) instrument developed for this purpose, and is based on the difference in the sum of the HD Symptoms Score (HDSIM questions 1through 8 which measures symptoms at their worst) for each of the two dosage regimens of the Study Drug compared to placebo at the End of Treatment (Day 15) versus Baseline (Day 1) divided by the sum of the Baseline (Day 1) component scores. |
| Secondary | Change From Baseline to Day 15 in Hemorrhoid Disease Symptom & Impact Measure (HDSIM) Component Scores | Baseline (Day 1) and End of Treatment (Day 15) | The Hemorrhoid Disease Symptom \& Impact Measure (HDSIM) is a participant-reported questionnaire assessing the preceding 24 hours. Mean changes from Baseline (Day 1) to End of Treatment (Day 15) are assessed separately for bowel health, life impact, mental health impact, and manageability, comparing each active treatment regimen with placebo. Items have five ordered response options, ranging from "Never" to "Always" or "Not at all" to "Very much." Responses toward "Always" or "Very much" indicate greater burden for bowel health, life impact, and mental health impact. For manageability, responses toward "Very much" indicate better coping, greater manageability, or greater confidence in treatment effectiveness. |
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/NCT07909291
GET https://conductscience.org/api/trials/v1/NCT07909291/registered