NIPH Clinical Trials Search

JRCT ID: jRCTs041230028

Registered date:30/05/2023

Evaluation of the tolerability of sustained-release morphine for patients with interstitial lung disease

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedinterstitial pneumonia
Date of first enrollment21/09/2023
Target sample size34
Countries of recruitment
Study typeInterventional
Intervention(s)Morphine sulfate hydrate extended-release fine granules, 5 mg twice daily for 3 days, then 10 mg twice daily every 12 hours for 7 days.


Primary OutcomeTreatment completion rate (tolerability) after 10 days of treatment
Secondary Outcome1. Adverse events (evaluation of the safety of morphine extended-release products) 2. Evaluation of dyspnea: mMRC questionnaire, NRS (Numerical Rating Scale) Worst (worst value within 24 hours), Average (average value over 24 hours) 3. Quality of life assessment related to interstitial pneumonia: CAT (COPD assessment test), K-BILD (King's Brief Interstitial Lung Disease Questionnaire) 4. Other assessment indices: ESAS-r-J ESAS-r-J (Edmonton Symptom Assessment System Revised Japanese version: Evaluation of overall physical condition) HADS (Hospital Anxiety Depression Scale: Assessment of depression) ECOG PS (Evaluation of performance status) EQ5D-5L (Evaluation of overall quality of life) 5. 4m walking speed (exertional load method)

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
Include criteria1. Patients who are 20 years old or older at the time of consent 2. Patients with a diagnosis of interstitial pneumonia 3. Patients with dyspnea (mMRC >= 3) despite standard therapy for the primary disease 4. All of the following laboratory values within 28 days prior to enrollment AST =< 100 IU/L, ALT =< 100 IU/L, T-Bil =< 2.0 mg/dL, serum Cre =< 2.0 mg/dL, SpO2 at rest >= 90% (oxygen can be administered) 5. Patients with a prognosis of more than 1 month 6. Patients who can answer and fill in the questionnaire by themselves 7. Patients whose written consent has been obtained from the patient
Exclude criteria1. Patients with severe respiratory depression 2. Patients with bronchial asthma attacks 3. Patients with severe hepatic impairment 4. Patients with physical findings suggestive of cardiac failure secondary to chronic pulmonary disease 5. Patients in a convulsive state 6. Patients with acute alcohol intoxication 7. Patients with hypersensitivity to opium alkaloids 8. Patients with hemorrhagic colitis 9. Patients receiving nalmefene hydrochloride hydrate or within 1 week of discontinuation of nalmefene hydrochloride hydrate 10. Patients with bacterial diarrhea 11. Patients with PaCO2 >= 60 Torr 12. Patients with symptoms of acute respiratory failure (e.g., bacterial pneumonia, acute exacerbation of interstitial pneumonia) within 1 months prior to enrollment 13. Patients with active infection-causing dyspnea 14. Patients with lung cancer complications causing dyspnea 15. Patients with complications of pulmonary thromboembolism 16. Patients on a ventilator 17. Patients on opioid preparations (except codeine phosphate hydrate less than 60 mg/day) 18. Patients with drug abuse, dependence, or a history of drug abuse or dependence 19. Pregnant women, lactating women, or patients who may be pregnant 20. Other patients deemed ineligible by the principal investigator or sub-investigator

Related Information


Public contact
Name Hideki Yasui
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka Shizuoka Japan 431-3192
Telephone +81-534352261
Affiliation Hamamatsu University Hospital
Scientific contact
Name Takafumi Suda
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka Shizuoka Japan 431-3192
Telephone +81-534352261
Affiliation Hamamatsu University School of Medicine.