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Strategies in Maintenance for Patients Receiving Long-term Therapy (S.I.M.P.L.E.) With MMX (Multi-Matrix System) Mesalamine for Ulcerative Colitis (UC)

NCT00446849 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 290

Last updated 2021-06-14

Study results available
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Summary

To evaluate the percentage of subjects with clinical recurrence of UC at 6 months using MMX mesalamine once daily.

Conditions

Interventions

DRUG

MMX Mesalamine

MMX™ mesalamine 2.4g/day to 4.8g/day once-daily (QD) (two to four 1.2g tablets MMX™ mesalamine, dosed QD,respectively).

Sponsors & Collaborators

  • Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-01
Primary Completion
2009-08-17
Completion
2009-08-17

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT00446849 on ClinicalTrials.gov