Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-24 @ 11:40 PM
NCT ID:
NCT00616551
Eligibility Criteria:
Inclusion Criteria:
* Subject must be diagnosed with active acromegaly.
* If subject is treated with a long acting somatostatin analogue, the treatment must have been unchanged for a period of at least 12 weeks prior to entry.
* If subject is treated with a 30 mg dose of a depot formulation of a somatostatin analogue, the IGF-1 levels must be normal at entry.
* If subject is treated with a 20 mg dose of a depot formulation of a somatostatin analogue, any value of IGF-1 is acceptable.
* If the subject is receiving an immediate release formulation of a somatostatin analogue or a dopamine agonist, the IGF-1 values must be above 10% of the reference range based on gender and age.
* If the subject is receiving a dopamine agonist, it must be stopped 14 days prior to receiving the study medication.
* The subject should be able to understand the instructions, provide a written consent and abide by the study restrictions.
Exclusion Criteria:
* Women of childbearing potential who are not taking adequate contraception or who are pregnant or lactating.
* Subjects previously treated with a growth hormone receptor antagonist (Pegvisomant) within 12 weeks of study entry.
* Subjects who have undergone pituitary surgery within 6 months or radiotherapy within 2 years prior to admission into the study
* Subjects who present some form of intolerance or allergy to the test article or one of its non-active ingredients
* Subject who have any other condition that alters the growth hormone or IGF-1 levels.
* Subjects with signs or symptoms related to a tumor compression of the optical chiasm.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00616551
Study Brief:
Protocol Section:
NCT00616551