MedTrace Logo

Safety, Efficacy, and Tolerability Study of ASP3291 in Patients With Active Ulcerative Colitis

NCT01612039 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2016-09-28

No results posted yet for this study

Summary

This is a Phase 2, randomized, double-blind, multicenter, parallel, placebo controlled study. Approximately 120 eligible patients with mild-to-moderate active ulcerative colitis will be randomized to double blind treatment of either 1,000 mg twice daily (b.i.d.) ASP3291 (2,000 mg/d) or matching placebo in a 1:1 ratio for 8 weeks.

The study hypothesis is that treatment with ASP3291 compared to placebo will improve a patient's ulcerative colitis endoscopic score from baseline to Week 8.

Conditions

Interventions

DRUG

ASP3291

Tablet, 1,000 mg (four 250-mg tablets), twice a day, 8 weeks

DRUG

Placebo

Matching placebo tablets

Sponsors & Collaborators

  • Telsar Pharma Inc.

    lead INDUSTRY

Principal Investigators

  • Robert Schinagl, Ph.D. · Drais Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2014-04-30
Completion
2014-04-30

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01612039 on ClinicalTrials.gov