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NCT02093663 · ClinicalTrials.gov registry record · Phase 3

Safety and Efficacy of MMX Mesalamine/Mesalazine in Pediatric Subjects With Mild to Moderate Ulcerative Colitis

A Phase 3 study, sponsored by Shire.

Completed
Registry status
Phase 3
Development phase
107
Enrollment target

NCT02093663 is a Phase 3 study that has completed, run by Shire. The registered enrollment target is 107 participants.

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The verdict

NCT02093663, a Phase 3 study, has completed, sponsored by Shire.

COMPLETED
Registry status
Phase 3
Development phase
107 participants
Enrollment target

Study Summary

To assess clinical response to MMX mesalamine/mesalazine between a low and high dose in children and adolescents aged 5-17 years with mild to moderate Ulcerative Colitis (UC) or who are in remission.

Interventions

  • DRUG MMX Mesalamine/Mesalazine (Low Dose)
  • DRUG MMX Mesalamine/Mesalazine (High Dose)

Trial Details

FieldValue
Enrollment Target 107 participants
Start Date 2014-12-12
Est. Completion 2018-11-28
Phase Phase 3

Sponsor

Shire

245 total trials

What the Registry Record Tells You About NCT02093663

The ClinicalTrials.gov registry entry for NCT02093663 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 107 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Shire, which has 245 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which MMX Mesalamine/Mesalazine (Low Dose) is the first listed.

NCT02093663 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02093663 about?

NCT02093663 is a clinical study titled "Safety and Efficacy of MMX Mesalamine/Mesalazine in Pediatric Subjects With Mild to Moderate Ulcerative Colitis". To assess clinical response to MMX mesalamine/mesalazine between a low and high dose in children and adolescents aged 5-17 years with mild to moderate Ulcerative Colitis (UC) or who are in remission.

What is the current status of trial NCT02093663?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 107 participants. The study started on 2014-12-12. Estimated completion is 2018-11-28.

What interventions are being tested in trial NCT02093663?

The interventions under investigation include: MMX Mesalamine/Mesalazine (Low Dose) (DRUG), MMX Mesalamine/Mesalazine (High Dose) (DRUG).

Who is sponsoring clinical trial NCT02093663?

This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.

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

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.