JPRN-jRCTs051190030
Recruiting
Phase 2
Randomized, placebo-controlled phase II study of efficacy of morphine for dyspnea in patients with interstitial lung disease: JORTC-PAL15
Matsuda Yoshinobu0 sites50 target enrollmentJune 27, 2019
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Matsuda Yoshinobu
- Enrollment
- 50
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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