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NCT02680756 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy Study of Oral Ferric Maltol Compared to Intravenous Iron To Treat Iron Deficiency Anaemia in IBD
A Phase 3 study of Crohn's Disease and Inflammatory Bowel Disease, sponsored by Shield Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 250
- Enrollment target
- 20
- Study locations
NCT02680756: Completed Phase 3 study of Crohn's Disease and Inflammatory Bowel Disease, sponsored by Shield Therapeutics.
NCT02680756 is a Phase 3 study of Crohn's Disease and Inflammatory Bowel Disease that has completed, run by Shield Therapeutics. The registered enrollment target is 250 participants, below the 2,392-participant average among 105 other Crohn's Disease trials with a reported enrollment target (90% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02680756, a Phase 3 study of Crohn's Disease and Inflammatory Bowel Disease, has completed, sponsored by Shield Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 250 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to compare the efficacy of ferric maltol and intravenous iron (IVI) Ferric Carboxy Maltose in the treatment of iron deficiency anaemia (IDA) and subsequent maintenance of haemoglobin in subjects with Inflammatory Bowel Disease (IBD).
Primary Outcome
Number of subjects achieving either a 2g/dL increase in Hb OR normalization of Hb (\>=12g/dL women,\>=13g/dL men) at Week 12
Conditions Studied
Interventions
- DRUG Ferric Maltol
- DRUG Ferric Carboxy Maltose
Study Locations (20)
Texas
- - Beaumont
- - Houston
- - San Antonio
Other
- - Ghent
- - Clichy
- - Lille
Florida
- - Gainesville
- - Hollywood
Tennessee
- - Germantown
- - Nashville
Washington
- - Bellevue
- - Seattle
Alabama
- - Dothan
Arizona
- - Tucson
Maryland
- - Chevy Chase
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2016-01 |
| Est. Completion | 2019-01 |
| Phase | Phase 3 |
What the finished NCT02680756 record still lists
NCT02680756 is an interventional study that assigns participants to a tested intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap, below the 2,392-participant average among 105 other Crohn's Disease trials with a reported enrollment target (90% lower).
The record links to 3 conditions, with Crohn's Disease appearing as the primary indexed condition, and to 2 interventions - of which Ferric Maltol is the first listed.
NCT02680756 names 20 study sites across 13 states, led by Texas, Other, Florida.
Frequently Asked Questions
What is clinical trial NCT02680756 about?
NCT02680756 is a clinical study titled "Safety and Efficacy Study of Oral Ferric Maltol Compared to Intravenous Iron To Treat Iron Deficiency Anaemia in IBD". The purpose of this study is to compare the efficacy of ferric maltol and intravenous iron (IVI) Ferric Carboxy Maltose in the treatment of iron deficiency anaemia (IDA) and subsequent maintenance of haemoglobin in subjects with Inflammatory Bowel Disease (IBD).
What is the current status of trial NCT02680756?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 250 participants. The study started on 2016-01. Estimated completion is 2019-01.
What conditions does trial NCT02680756 study?
This clinical trial studies the following conditions: Crohn's Disease, Inflammatory Bowel Disease, Anemia, Iron Deficiency.
What interventions are being tested in trial NCT02680756?
The interventions under investigation include: Ferric Maltol (DRUG), Ferric Carboxy Maltose (DRUG).
Who is sponsoring clinical trial NCT02680756?
This trial is sponsored by Shield Therapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02680756 being conducted?
This trial has 20 study locations across Alabama, Arizona, Florida, Maryland, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02680756's enrollment target sits among peer trials
250 47th of 105 higher than 59 of 105 other Crohn's Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Crohn's Disease 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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