# FACTS I: A Study to Test the Safety and Effectiveness of a New Medication on the Treatment of Active Ulcerative Colitis

> **NCT00064441** · PHASE3 · COMPLETED · sponsor: **Otsuka Pharmaceutical Development & Commercialization, Inc.** · enrollment: 375 (—)

## Conditions studied

- Ulcerative Colitis

## Interventions

- **DRUG:** OPC-6535 Tablets (drug)

## Key facts

- **NCT ID:** NCT00064441
- **Lead sponsor:** Otsuka Pharmaceutical Development & Commercialization, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2003-05
- **Primary completion:** 2006-05
- **Final completion:** 2006-05
- **Target enrollment:** 375 (—)
- **Last updated:** 2012-05-10


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT00064441

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT00064441, "FACTS I: A Study to Test the Safety and Effectiveness of a New Medication on the Treatment of Active Ulcerative Colitis". Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/clinical/NCT00064441. Licensed CC0.

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