Evaluation of the tolerability, safety, and efficacy of sustained-release morphine for patients with interstitial pneumonia accompanied by dyspnea

Suda Takafumi0 个研究点目标入组 34 人开始时间: 2023年5月30日最近更新: 2024年4月23日

适应症

试验速览

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•1. 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

•1. 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

发起方

Suda Takafumi