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Mesalamine 2 g Sachet for the Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis (UC)

NCT02522780 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 276

Last updated 2021-11-08

Study results available
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Summary

The purpose of this trial was to investigate the safety and efficacy of mesalamine 2 g extended release granules (sachet) once a day (QD) for maintenance of clinical and endoscopic remission in subjects with UC. The duration of treatment for each subject was 6 months.

Conditions

Interventions

DRUG

Mesalamine

Pharmaceutical form: Granules in sachet; Route of administration: Oral use

DRUG

Placebo

Pharmaceutical form: Granules in sachet; Route of administration: Oral use

Sponsors & Collaborators

  • Ferring Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Global Clinical Compliance · Ferring Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-02-01
Primary Completion
2018-09-19
Completion
2018-09-19

Countries

  • United States
  • Bulgaria
  • Canada
  • Hungary
  • Latvia
  • Mexico
  • Poland
  • Russia
  • Serbia
  • Switzerland
  • Ukraine

Study Locations

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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 NCT02522780 on ClinicalTrials.gov