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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.

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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

FieldValue
Enrollment Target 91 participants
Start Date 2016-12
Est. Completion 2018-04
Phase Phase 2

Sponsor

NovaBiotics

1 total trials

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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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.