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COMPLETED Phase 3

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

NCT02522780 · View on ClinicalTrials.gov ↗

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

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

27 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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 276 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ferring Pharmaceuticals, which has 27 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02522780 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Florida, Texas, North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02522780?

The interventions under investigation include: Placebo (DRUG), Mesalamine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02522780?

This trial is sponsored by Ferring Pharmaceuticals, which has 27 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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