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临床试验/CTRI/2023/01/048893
CTRI/2023/01/048893尚未招募2 期

Randomized double blind placebo-controlled clinical trial â?? an exploratory study to investigate the efficacy of moclobemide as an add-on treatment in castration-resistant prostate cancer patients

ICMR-Product Development Centre at AIIMS New Delhi0 个研究点目标入组 0 人开始时间: 待定最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • 1.Age>=18 years
  • 2.Castration-resistant prostate cancer patients (CRPC): Disease progression despite androgen-deprivation therapy (ADT) and may present as one or any combination of a continuous rise in serum levels of prostate-specific antigen (PSA), progression of pre-existing disease, or appearance of new metastases (Ga-68-PSMA PET/CT Scan) and characterized by low levels of testosterone ( <50 ng/dl).

排除标准

  • 1.Patients who are not willing to participate
  • 2.Active psychiatric illnesses that would limit compliance with protocol requirements
  • 3.Patients taking tricyclic/tetracyclic antidepressants or selective serotonin reuptake inhibitors, or serotonin norepinephrine reuptake inhibitors or conventional monoamine oxidase inhibitors or thioridazine or dextromethorphan or bupropion or triptans or tramadol or meperidine or selegiline or any antipsychotic drugs or sympathomimetic drugs or linezolid
  • 4.Patients with connective tissue disorders like systemic lupus erythematosus, rheumatoid arthritis, systemic sclerosis and other autoimmune disorders
  • 5.Patients with hepatic dysfunction that is those in whom serum bilirubin will be more than 1.5 and, AST and ALT will be more than 2.5 fold higher than the upper limit of normal
  • 6.Patients in whom serum creatinine will be more than 1.5 fold higher than the upper limit of normal
  • 7.Patients with congestive cardiac failure, severe or unstable angina or thyrotoxicosis
  • 8.Atrial Fibrillation, or other cardiac arrhythmia requiring medical therapy
  • 9.Administration of any other investigational therapeutic agent within 30 days of screening
  • 10.Prior radiation therapy completed < 4 weeks prior to enrolment
  • 11.Any currently active second malignancy
  • 12.Patients in whom urgent chemotherapy, in the opinion of the treating physician, is indicated
  • 13.Patients taking strong CYP2D6, CYP2C19 and CYP3A4 inducer or inhibitor, available from Metabolism and Transport Drug Interaction Database (http://www.druginteractioninfo.org)
  • 14.Pheochromocytoma
  • 15.Carcinoid Syndrome
  • 16.Angle-closure glaucoma

研究者

发起方
ICMR-Product Development Centre at AIIMS New Delhi

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