Effects of octreotide LAR treatment on QOL, clinical symptoms and endocrinological data in patients with acromegaly or pituitary gigantism

UMIN ID: C000000258

Registered date:05/10/2005

Basic Information

• Health condition(s) or Problem(s) studied: acromegaly and pituitary gigantism
• Date of first enrollment: 2005/10/01
• Target sample size: 50
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Octreotide LAR 10mg-40mg

Outcome(s)

• Primary Outcome: 1. QOL(SF-36) 2. Clinical symptom(headache, sweating, arthralgia, carpal-tunnel syndrome, and other clinical symptoms) 3. Serum GH 4. Serum IGF-1
• Secondary Outcome: 1. Complication(blood pressure, glucose tolerance status, dyslipidemia, and cardiovascular diseases 2. Adverse events

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1) Patients who have previous history of hypersensitivity for elements of Octreotide. 2) Patients whose serum bilirubin or serum creatinine concentration exceeds three times of the upper level of normal ranges. 3) Patients whose AST(GOT) or ALT(GPT) concentration exceeds five times of the upper level of normal ranges.

Related Information

• Primary Sponsor: Kansai Study Groups for Hypothalamic and Pituitary Diseases
• Source(s) of Monetary Support: None