# The Safety and Tolerability of Budesonide Foam in Participants With Active Ulcerative Proctitis or Proctosigmoiditis

> **NCT01349673** · PHASE3 · TERMINATED · sponsor: **Bausch Health Americas, Inc.** · enrollment: 114 (actual)

## Conditions studied

- Proctitis
- Proctosigmoiditis

## Interventions

- **DRUG:** Budesonide Foam

## Key facts

- **NCT ID:** NCT01349673
- **Lead sponsor:** Bausch Health Americas, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2011-05-31
- **Primary completion:** 2014-12-31
- **Final completion:** 2014-12-31
- **Target enrollment:** 114 (ACTUAL)
- **Why stopped:** Terminated for non-safety reasons when Sponsor felt that sufficient long-term safety data was obtained.
- **Last updated:** 2019-08-14


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01349673

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01349673, "The Safety and Tolerability of Budesonide Foam in Participants With Active Ulcerative Proctitis or Proctosigmoiditis". Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/clinical/NCT01349673. Licensed CC0.

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