A prospective, randomized, single- blind, controlled study to investigate the effect of suplatast tosilate on early- stage idiopathic pulmonary fibrosis

A prospective, randomized, single- blind, controlled study to investigate the effect of suplatast tosilate on early- stage idiopathic pulmonary fibrosis - A clinical study to investigate the effect of suplatast tosilate on early- stage idiopathic pulmonary fibrosis

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001567

Enrollment

Registered

2008-12-25

Start date

2008-11-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic pulmonary fibrosis

Interventions

Observation with placebo Treatment with suplatast tosilate

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with non-treated, early- stage idiopathic pulmonary fibrosis 2. Patients aged between 50 and 79 3. Disease severity ranged from grade 1 to grade 2 4. Patients who sign the agreement form to participate in this study 5. No previous treatment with suplatast tosilate

Exclusion criteria

Exclusion criteria: 1. Patients who cannot carry out pulmonary function test 2. Patients whose causes for interstitial pneumonia are apparent. 3. Patients who participated in a clinical trial within the past three months 4. Patients who contraindicate for suplatast tosilate. 5. Patients who are judged to be unfit for the study by the investigator

Design outcomes

Primary

Measure	Time frame
Pulmonary function test	—

Secondary

Measure	Time frame
Six-minute walk distance Serum markers (KL-6,SP-D,SP-A) Radiological findings Subjective symptoms Safety	—

Countries

Japan

Contacts

Public ContactNoboru Hatori

Hiroshima University Department of Molecular and Internal Medicine

nhattori@hiroshima-u.ac.jp082-257-5196

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026