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COMPLETED Phase 3

Randomized Placebo-Controlled Trial of Budesonide Multi-Matrix System (MMX®) 9 Milligrams (mg) in Participants With Ulcerative Colitis Currently on a 5-Aminosalicylic Acid (5-ASA)

NCT01532648 · View on ClinicalTrials.gov ↗

Study Summary

This study is to compare the efficacy and safety of budesonide MMX 9 mg versus placebo as add-on therapy to an existing oral 5-ASA regimen for the induction of remission in participants with active mild or moderate ulcerative colitis (UC).

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Budesonide MMX®
  • DRUG 5-ASA

Study Locations (20)

Florida

  • Santarus Clinical Investigational Site 1035 — Boynton Beach
  • Santarus Clinical Investigational Site 1045 — Jacksonville
  • Santarus Clinical Investigational Site 1001 — Largo
  • Santarus Clinical Investigational Site 1024 — Maitland
  • Santarus Clinical Investigational Site 1029 — Port Orange
  • Santarus Clinical Investigational Site 1010 — Winter Park
  • Santarus Clinical Investigational Site 1002 — Zephyrhills

California

  • Santarus Clinical Investigational Site 1043 — Anaheim
  • Santarus Clinical Investigational Site 1071 — Lakewood
  • Santarus Clinical Investigational Site 1003 — San Diego

Illinois

  • Santarus Clinical Investigational Site 1075 — Chicago
  • Santarus Clinical Investigational Site 1065 — Oak Lawn

Michigan

  • Santarus Clinical Investigational Site 1016 — Chesterfield
  • Santarus Clinical Investigational Site 1081 — Novi

Colorado

  • Santarus Clinical Investigational Site 1063 — Littleton

Connecticut

  • Santarus Clinical Investigational Site 1028 — Bristol

Georgia

  • Santarus Clinical Investigational Site 1050 — Decatur

Indiana

  • Santarus Clinical Investigational Site 1058 — Indianapolis

Trial Details

FieldValue
Enrollment Target 510 participants
Start Date 2012-01-27
Est. Completion 2013-10-02
Phase Phase 3

Sponsor

Bausch Health Americas

55 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01532648

The ClinicalTrials.gov registry entry for NCT01532648 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 510 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bausch Health Americas, which has 55 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 3 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: NCT01532648 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Florida, California, Illinois. 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 NCT01532648 about?

NCT01532648 is a clinical study titled "Randomized Placebo-Controlled Trial of Budesonide Multi-Matrix System (MMX®) 9 Milligrams (mg) in Participants With Ulcerative Colitis Currently on a 5-Aminosalicylic Acid (5-ASA)". This study is to compare the efficacy and safety of budesonide MMX 9 mg versus placebo as add-on therapy to an existing oral 5-ASA regimen for the induction of remission in participants with active mild or moderate ulcerative colitis (UC).

What is the current status of trial NCT01532648?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 510 participants. The study started on 2012-01-27. Estimated completion is 2013-10-02.

What conditions does trial NCT01532648 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 NCT01532648?

The interventions under investigation include: Placebo (DRUG), Budesonide MMX® (DRUG), 5-ASA (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01532648?

This trial is sponsored by Bausch Health Americas, which has 55 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01532648 being conducted?

This trial has 20 study locations across California, Colorado, Connecticut, Florida, Georgia. 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