Treatment-naive acromegaly due to pituitary adenoma in a Japanese patient
Conditions
Interventions
In the 1st period, a single subcutaneous injection of GT-02037 2.0 milligram or Octreotide 50 microgram.
In the 2nd period, a single subcutaneous injection of a different investigational drug from the
Sponsors
Wada Jun
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese over 18 years old, at the time the informed consent was obtained 2. Patients with definite diagnosis of Acromegaly 3. Patients who give written consent with their free will prior to participation in this clinical trial
Exclusion criteria
Exclusion criteria: 1. Patients who have undergone surgery to remove the pituitary gland tumor 2. Patients who have received radiation therapy for pituitary gland tumor 3. Patients receiving drug treatment with drugs that affect GH or the pituitary gland system (Somatostatin analogs, Dopamine agonists, GH antagonists, etc.), and the Investigator determines that these effects will remain at the time of study entry 4. Patients with a medical history of hypersensitivity to any of the components of the investigational drug in this study 5. Patients undergoing treatment for ongoing malignancies 6. Patients with serious systemic diseases (hepatic, renal, cardiovascular, endocrine, respiratory, etc.) or serious psychiatric diseases 7. Pregnant/possibly pregnant or lactating patients 8. HIV antigen/antibody, HBs antigen, or HCV antibody positive patients 9. Patients who have received any other investigational drug (including Post-marketing Clinical Trial drugs) within 12 weeks prior to the start of treatment with the investigational drug in this study 10. Patients with a history of alcohol or drug abuse within the past 12 months 11. Patients who are deemed unsuitable as subjects by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Decreasing rate in blood GH level at the point of the largest decrease from the pre-administration value (Maximal reduction rate) | — |
Contacts
Public ContactHideki Uno
Okayama University Hospital
Outcome results
None listed