CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 123 enrolled
Drug / intervention
Matching Placebo +2 moredrug
Likely dose
N-acetylcysteine 600 mgfrom 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.

Search/NCT02707640
NCT02707640Phase 2Completed
CompareCT.gov

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N-Acetylcysteine in Patients With Idiopathic Pulmonary Fibrosis With Background Treatment of Pirfenidone

Hoffmann-La Roche·interventional·Posted Mar 14, 2016·Updated May 20, 2016

In Brief

A Phase 2 clinical trial evaluating Matching Placebo, N-acetylcysteine, and 1 other intervention for Idiopathic Pulmonary Fibrosis. Completed, enrolled 123 participants across 69 sites in 8 countries.

Detailed Summary

This is a Phase 2, randomized, double-blind, placebo-controlled safety and tolerability study of N-acetylcysteine or placebo in participants with mild to moderate idiopathic pulmonary fibrosis (IPF) receiving background pirfenidone therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIdiopathic Pulmonary Fibrosis
CountriesAustria, Belgium, Denmark, France, Germany, Italy, Sweden, United Kingdom
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 14, 2016
Enrollment StartAug 1, 2013
Primary CompletionFeb 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 10.3 years ago

Interventions

Matching Placebodrug

Matching Placebo, oral administration, three times daily for 24 weeks.

N-acetylcysteinedrug

N-acetylcysteine, 600 mg, oral administration, three times daily for 24 weeks.

Pirfenidonedrug

Pirfenidone, at least 1602 mg/day, oral administration, for 32 weeks, during the wash-out and screening period and for at least 8 weeks prior to randomization.