se of somatostatin analogue therapy as primary medical treatment of acromegaly - medical treatment of acromegaly
- Conditions
- Acromegaly
- Registration Number
- EUCTR2005-004300-36-GB
- Lead Sponsor
- Plymouth Hospital NHS Trust, R&D dept
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 10
• The patient must give written (personally signed and dated) informed consent
• The patient is over 18 years of age inclusive.
• The patient has active acromegaly as diagnosed by oral glucose tolerance test and IGF-1 measurement. Acromegaly must be confirmed prior to study entry based on failure to suppress GH during an oral glucose tolerance test and IGF-1 above the normal range.
• The patient has a pituitary adenoma tumour size greater than 5 mm along the longest axis on MRI.
• The patient has a life expectancy of at least 2 years.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
• The patient is considered unfit for surgery.
• The patient has a significant visual field defect thought to be due to optic chiasm compression at the time of presentation where the risk of visual loss is considered too great to delay surgery.
• The patient has a pituitary adenoma tumour of 5 mm or less along the longest axis, with margins clearly defined within pituitary fossa.
• The patient has had any prior pituitary surgery (adenectomy).
• The patient has received pituitary radiotherapy within one year prior to screening.
• The patient has been previously treated with a GH antagonist or a somatostatin analogue.
• The patient has clinically significant renal or hepatic abnormalities.
• The patient is pregnant or lactating.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method