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NCT04325217 Clinical Trial

Post-marketing Surveillance on Long Term Use of Ofev Capsules in Systemic Scleroderma Associated Interstitial Lung Disease (SSc-ILD) in Japan

Lung Diseases, Interstitial Clinical Trial

Official title:
Post-marketing Surveillance on Long Term Use of Ofev Capsules in Systemic Scleroderma Associated Interstitial Lung Disease (SSc-ILD) in Japan

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04325217
Other study ID # 1199-0387
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date April 15, 2020
Est. completion date September 30, 2026

Study information
Verified date April 2024
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The primary objective is to confirm the incidence of adverse drug reactions (focus on gastrointestinal symptoms including diarrhoea and nausea) to Ofev Capsules seen in clinical trials with real world data generated in patients with SSc-ILD.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 585
Est. completion date September 30, 2026
Est. primary completion date June 30, 2026
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Patients in Japan with SSc-ILD who are prescribed with Ofev Capsules and have never been treated with Ofev Capsules before enrolment will be included. Exclusion Criteria: - None.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Nintedanib
Capsules

Locations
Country Name City State
Japan Nippon Boehringer Ingelheim Co., Ltd. Tokyo

Sponsors (1)
Lead Sponsor Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of adverse drug reactions (ADRs) Focus on gastrointestinal symptoms including diarrhea and nausea up to 3 years and 9 months
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