acromegaly and pituitary gigantism
Conditions
Interventions
Treatment Period I (12 weeks)
SK-5307 (any of Dose 1, Dose 2, or Dose 3) is orally administered once a day.
Treatment Period II (40 weeks)
SK-5307 is orally administered once a day to the subjects who
Sponsors
Kazuo Kuyama
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects who were diagnosed with acromegaly or pituitary gigantism and have undergone pituitary surgery at least once, refused to undergo pituitary surgery or with contraindications to pituitary surgery. Subjects whose serum IGF-1 concentration is 1.3 times higher than the upper limit of normal (ULN) for age and gender at the screening test. Subjects who have never used existing medications to treat acromegaly or pituitary gigantism. Subjects on existing monotherapy to treat acromegaly or pituitary gigantism without any changes in the dosage and administration for 12 weeks prior to providing written informed consent. Subjects who have participated in any previous clinical study of SK-5307 and received SK-5307 (excluding placebo of SK-5307). Subjects deemed inappropriate by the investigator or subinvestigator.
Exclusion criteria
Exclusion criteria: Subjects with a history of ineffectiveness of or significant intolerance for existing medications. Subjects deemed unsuitable for existing monotherapy. Subjects who are receiving two or more medications to treat acromegaly or pituitary gigantism at the time of the informed consent. Subjects who underwent pituitary radiation therapy within 3 years prior to the screening test. Subjects who underwent pituitary surgery within 12 weeks prior to the screening test. Subjects with a high risk of pituitary tumor. Subjects with hypersensitivity or a history of hypersensitivity to somatostatin analogue. Subjects with symptomatic cholelithiasis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment Period I Change from baseline in serum IGF-1 concentration at the end of Treatment Period I Treatment Period II. Percentage of the subjects achieving serum IGF-1 concentrations within the reference ranges for age and gender at the end of Treatment Period II. | — |
Contacts
Public ContactKuyama Kazuo
Sanwa Kagaku Kenkyusho Co.,Ltd.
Outcome results
None listed