# Phase 3 Study to Evaluate the Safety and Efficacy of Hydrocortisone Acetate Suppositories

> **NCT04469686** · PHASE3 · COMPLETED · sponsor: **Cristcot LLC** · enrollment: 200 (actual)

## Conditions studied

- Ulcerative Proctitis

## Interventions

- **COMBINATION_PRODUCT:** Twice daily 90 mg hydrocortisone acetate suppository administered with Sephure applicator
- **COMBINATION_PRODUCT:** Once daily 90 mg hydrocortisone acetate or placebo suppository administered with Sephure applicator
- **COMBINATION_PRODUCT:** Twice daily placebo suppository administered with Sephure applicator

## Key facts

- **NCT ID:** NCT04469686
- **Lead sponsor:** Cristcot LLC
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2020-12-10
- **Primary completion:** 2024-07-16
- **Final completion:** 2024-09-19
- **Target enrollment:** 200 (ACTUAL)
- **Last updated:** 2025-07-30

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04469686

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04469686, "Phase 3 Study to Evaluate the Safety and Efficacy of Hydrocortisone Acetate Suppositories". Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/clinical/NCT04469686. Licensed CC0.

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