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A Study to Assess the Safety and Tolerability of N-Acetylcysteine When Administered With Pirfenidone to Participants With Idiopathic Pulmonary Fibrosis (IPF)

NCT02707640 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 123

Last updated 2016-05-20

Study results available
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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.

Conditions

Interventions

DRUG

Matching Placebo

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

DRUG

N-acetylcysteine

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

DRUG

Pirfenidone

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.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2015-02-28
Completion
2015-02-28

Countries

  • Austria
  • Belgium
  • Denmark
  • France
  • Germany
  • Italy
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02707640 on ClinicalTrials.gov