At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 91 enrolled
Drug / intervention
Cysteamine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study Investigating the Optimal Dose Regimen, Efficacy, and Safety of Adding Oral Cysteamine in Adult Patients Being Treated for an Exacerbation of CF-associated Lung Disease
In Brief
A Phase 2 clinical trial evaluating Cysteamine and Placebo Oral Capsule for Cystic Fibrosis. Completed, enrolled 91 participants across 17 sites in 3 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesItaly, United Kingdom, United States
CollaboratorsAgility Clinical, Inc., PSR Group B.V.
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartDec 2016
First PostedDec 2016
Primary CompletionApr 2018
TodayJul 2026
First PostedDec 22, 2016
Enrollment StartDec 1, 2016
Primary CompletionApr 1, 2018
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 9.5 years ago
Interventions
Cysteaminedrug
Oral Cysteamine Capsule
Placebo Oral Capsuledrug
Placebo Oral Capsule