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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: Completed Phase 3 study of Ulcerative Colitis, sponsored by Ferring Pharmaceuticals.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The proportion of subjects with remission was defined by Clinical and Endoscopic Response Score: 0 for rectal bleeding; 0 or 1 for stool frequency; 0 or 1 for endoscopic score. The Clinical and Endoscopic Response Score ranged between 0 (normal) to 9 (severe disease), higher scores indicating greater disease severity. The score included clinical response component to assess subject's symptoms and endoscopic response component to assess objective evidence of inflammation. Clinical response compon
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
| Field | Value |
|---|---|
| Enrollment Target | 276 participants |
| Start Date | 2016-02-01 |
| Est. Completion | 2018-09-19 |
| Phase | Phase 3 |
What the finished NCT02522780 record still lists
NCT02522780 is an interventional study that assigns participants to a tested intervention. The registered 276 participants enrollment target is mid-sized for trials with a published cap, below the 2,055-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (87% lower).
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 names 20 study sites across 10 states, led by 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.
Learn More About Clinical Trials
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Where NCT02522780's enrollment target sits among peer trials
276 35th of 122 higher than 88 of 122 other Ulcerative Colitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ulcerative Colitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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