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NCT03000348 · ClinicalTrials.gov registry record · Phase 2
A Study of the Dosing, Efficacy, and Safety of Oral Cysteamine in Adult Patients With Cystic Fibrosis Exacerbations
A Phase 2 study of Cystic Fibrosis, sponsored by NovaBiotics.
- Completed
- Registry status
- Phase 2
- Development phase
- 91
- Enrollment target
- 17
- Study locations
NCT03000348 is a Phase 2 study of Cystic Fibrosis that has completed, run by NovaBiotics. The registered enrollment target is 91 participants, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (49% lower). The trial reports 17 study locations across 9 states.
The verdict
NCT03000348, a Phase 2 study of Cystic Fibrosis, has completed, sponsored by NovaBiotics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 91 participants
- Enrollment target
- 17
- Study locations
Study Summary
This study investigates the use of cysteamine in the treatment of adults with Cystic Fibrosis who are experiencing an exacerbation of CF-associated lung disease. There are six different potential dosing regimens, including one that is placebo.
Conditions Studied
Interventions
- DRUG Cysteamine
- DRUG Placebo Oral Capsule
Study Locations (17)
Other
- Ospedale Padiatrico Bambino Gesu Centro Fibrosi Cistica - Roma
- Azienda Ospedaliera Universitaria Integrato di Verona Borgo Trento Centro Fibrosi Cistica - Verona
- Ninewells Hospital Scottish Adult Cystic Fibrosis Service - Dundee
- Western General Hospital Edinburgh, CF Adults / CF Unit - Edinburgh
- NHS GGC - Glasgow
- Raigmore Hospital - Inverness
- St. James University Hospital - Leeds
- Royal Victoria Infirmary Adult CF Centre - Newcastle upon Tyne
Florida
- University of Florida - Gainesville
- Central Florida Pulmonary - Orlando
Arizona
- Banner University of Arizona Medical Center - Tucson
California
- San Francisco Critical Care Medical Group California Pacific Medical Center - San Francisco
New York
- Albany Medical College - Albany
Ohio
- Nationwide Children's Hospital - Columbus
West Virginia
- West Virginia University - Morgantown
Wisconsin
- The Medical College of Wisconsin/Froedtert Hospital - Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 91 participants |
| Start Date | 2016-12 |
| Est. Completion | 2018-04 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03000348
The ClinicalTrials.gov registry entry for NCT03000348 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 91 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (49% lower). The listed sponsor is NovaBiotics, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Cystic Fibrosis appearing as the primary indexed condition, and to 2 interventions - of which Cysteamine is the first listed.
NCT03000348 reports 17 study locations spanning 9 distinct geographic areas - top geographies include Other, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT03000348 about?
NCT03000348 is a clinical study titled "A Study of the Dosing, Efficacy, and Safety of Oral Cysteamine in Adult Patients With Cystic Fibrosis Exacerbations". This study investigates the use of cysteamine in the treatment of adults with Cystic Fibrosis who are experiencing an exacerbation of CF-associated lung disease. There are six different potential dosing regimens, including one that is placebo.
What is the current status of trial NCT03000348?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 91 participants. The study started on 2016-12. Estimated completion is 2018-04.
What conditions does trial NCT03000348 study?
This clinical trial studies the following conditions: Cystic Fibrosis.
What interventions are being tested in trial NCT03000348?
The interventions under investigation include: Cysteamine (DRUG), Placebo Oral Capsule (DRUG).
Who is sponsoring clinical trial NCT03000348?
This trial is sponsored by NovaBiotics, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03000348 being conducted?
This trial has 17 study locations across Arizona, California, Florida, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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