# Assessing the Safety/Efficacy of Asacol® Given Every 12 Hours to Children and Adolescents for the Maintenance of Remission of Ulcerative Colitis

> **NCT01004185** · PHASE3 · TERMINATED · sponsor: **Warner Chilcott** · enrollment: 39 (actual)

## Conditions studied

- Ulcerative Colitis

## Interventions

- **DRUG:** Asacol 400 mg
- **DRUG:** Asacol 400 mg

## Key facts

- **NCT ID:** NCT01004185
- **Lead sponsor:** Warner Chilcott
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2009-10
- **Primary completion:** 2011-03
- **Final completion:** 2011-03
- **Target enrollment:** 39 (ACTUAL)
- **Why stopped:** Pediatric enrollment very slow.
- **Last updated:** 2012-05-25


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01004185

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01004185, "Assessing the Safety/Efficacy of Asacol® Given Every 12 Hours to Children and Adolescents for the Maintenance of Remission of Ulcerative Colitis". Retrieved via AI Analytics 2026-06-04 from https://api.ai-analytics.org/clinical/NCT01004185. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*
