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Nintedanib With or Without Dextromethorphan in Patients With Idiopathic Pulmonary Fibrosis (IPF)

NCT07583589 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-05-13

No results posted yet for this study

Summary

Nintedanib combined with or without Dextromethorphan for the treatment of IPF, with FVC as the primary efficacy endpoint to evaluate its effectivenes.

Conditions

  • Idiopathic Pulmonary Fibrosis (IPF)

Interventions

DRUG

Nintedanib,Dextromethorphan

Dosage of Nitedanib is 150mg/100mg each time, twice a day, once in the morning and once in the evening, It is recommended to take it with meals. The dosage of Dextromethorphan sustained-release tablets is 30 mg, twice a day. It is recommended to take it orally 30 minutes after meals. For 12 weeks.

DRUG

Nintedanib,Placebo

Dosage of Nitedanib is 150mg/100mg each time, twice a day, once in the morning and once in the evening, with an interval of 12hours. It is recommended to take it with meals to reduce gastrointestinal adverse reactions. Placebo, twice a day, recommended to be taken in the morning and evening. For 12 weeks.

Sponsors & Collaborators

  • First Affiliated Hospital of Wenzhou Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-12
Primary Completion
2027-03-01
Completion
2027-06-01

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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 NCT07583589 on ClinicalTrials.gov