# Efficacy and Safety of Budesonide Foam for Participants With Active Mild to Moderate Ulcerative Proctitis or Proctosigmoiditis

> **NCT01008423** · PHASE3 · COMPLETED · sponsor: **Bausch Health Americas, Inc.** · enrollment: 281 (actual)

## Conditions studied

- Proctitis
- Proctosigmoiditis

## Interventions

- **DRUG:** Budesonide
- **DRUG:** Placebo

## Key facts

- **NCT ID:** NCT01008423
- **Lead sponsor:** Bausch Health Americas, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2009-11-20
- **Primary completion:** 2013-03-18
- **Final completion:** 2013-03-18
- **Target enrollment:** 281 (ACTUAL)
- **Last updated:** 2019-08-14


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01008423

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01008423, "Efficacy and Safety of Budesonide Foam for Participants With Active Mild to Moderate Ulcerative Proctitis or Proctosigmoiditis". Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/clinical/NCT01008423. Licensed CC0.

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