Randomized, placebo-controlled phase II study of efficacy of morphine for dyspnea in patients with interstitial lung disease: JORTC-PAL15

Phase 2

Recruiting

• Conditions: Interstitial lung disease; Lung Diseases, Interstitial

• Registration Number: JPRN-jRCTs051190030
• Lead Sponsor: Matsuda Yoshinobu

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-27
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1.Patients who are diagnosed with ILD by two respiratory physicians and one respiratory radiologist
2.Patients who have dyspnea at restdespite conventional treatment, with NRS 3 or more
3.Patients who have normal liver and renal function ( AST 100 IU/L or less, ALT 100 IU/L or less, T-Bil 2.0 mg/dL or less, sCre 2.0 mg/dL or less), blood oxygen saturation levels (SpO2) 90% or more and partial pressure of carbon dioxide (PaCO2) 60 Torr or less (Supplemental oxygen was allowed)
4.Adult patients (20 years old or older)
5.Patients who has expected survival of 1 month or longer
6.Patients who is capable of communication and did not have cognitive impairments
7.Patients who provided written informed consents

Exclusion Criteria

1.Patients who have contraindication for morphine
2.Patients who use opioids
3.Patients who have left heart failure (EF < 50%) confirmed by echocardiography
4.Patients who have acute respiratory failure
5.Patients who have infection that causes dyspnea
6.Patients who have lung cancer that causes dyspnea
7.Patients who have bronchial asthma attack
8.Patients who have pneumothorax requiring thoracic drainage
9.Patients who use mechanical ventilation
10.Patients who have current or past history of drug abuse
11.Patients who are pregnant

Study & Design

• Study Type: Interventional
• Study Design: Not specified