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NCT02522780 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Ulcerative Colitis, sponsored by Ferring Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
276
Enrollment target
20
Study locations

NCT02522780 is a Phase 3 study of Ulcerative Colitis that has completed, run by Ferring Pharmaceuticals. The registered enrollment target is 276 participants, below the 2,055-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (87% lower). The trial reports 20 study locations across 10 states.

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The verdict

NCT02522780, a Phase 3 study of Ulcerative Colitis, has completed, sponsored by Ferring Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
276 participants
Enrollment target
20
Study locations

Study 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 Studied

Ulcerative Colitis

Interventions

  • DRUG Placebo
  • DRUG Mesalamine

Study Locations (20)

Florida

  • Research Associates of South Florida, LLC - Miami
  • IMIC - Palmetto Bay
  • Medical Research Center of Florida - Pembroke Pines
  • Lenus Research and Medical Group - Sweetwater

Texas

  • BI Research Center - Houston
  • Biopharma Informatic Inc. - Houston
  • Digestive Health Center - Pasadena
  • DM Clinical Research - Tomball

North Carolina

  • Cumberland Research Associates, LLC - Fayetteville
  • Wilmington Gastroenterology Associates - Wilmington

Tennessee

  • Associates in Gastroenterology, PLC - Hermitage
  • Quality Medical Research, PLLC - Nashville

Virginia

  • New River Valley Research Institute - Christiansburg
  • Digestive & Liver Disease Specialists - Norfolk

Other

  • Multiprofile Hospital For Active Treatment Avis Medica - Pleven
  • University Multiprofile Hospital for Active Treatment Kaspela - Plovdiv

Arkansas

  • Preferred Research Partners - Little Rock

California

  • United Research Institute - Murrieta

Trial Details

FieldValue
Enrollment Target 276 participants
Start Date 2016-02-01
Est. Completion 2018-09-19
Phase Phase 3

Sponsor

Ferring Pharmaceuticals

83 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02522780

The ClinicalTrials.gov registry entry for NCT02522780 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 276 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,055-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (87% lower). The listed sponsor is Ferring Pharmaceuticals, which has 83 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Ulcerative Colitis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT02522780 reports 20 study locations spanning 10 distinct geographic areas - top geographies include Florida, Texas, North Carolina.

Frequently Asked Questions

What is clinical trial NCT02522780 about?

NCT02522780 is a clinical study titled "Mesalamine 2 g Sachet for the Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis (UC)". 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.

What is the current status of trial NCT02522780?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 276 participants. The study started on 2016-02-01. Estimated completion is 2018-09-19.

What conditions does trial NCT02522780 study?

This clinical trial studies the following conditions: Ulcerative Colitis.

What interventions are being tested in trial NCT02522780?

The interventions under investigation include: Placebo (DRUG), Mesalamine (DRUG).

Who is sponsoring clinical trial NCT02522780?

This trial is sponsored by Ferring Pharmaceuticals, which has 83 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02522780 being conducted?

This trial has 20 study locations across Arkansas, California, Florida, Louisiana, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.