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:
2025-12-26 @ 12:17 PM
Ignite Modification Date:
2025-12-26 @ 12:17 PM
NCT ID:
NCT02217800
Eligibility Criteria:
Inclusion Criteria:
* Men, women of non child-bearing potential, or women of child-bearing potential who either abstain from sexual intercourse, have a sterile partner or practice two medically approved, non-hormonal methods of contraception
* Diagnosis of acromegaly of pituitary origin
* Have an age-adjusted insulin-like growth factor type 1 (IGF-1) concentration ≥1.2 times the upper limit of normal range on at least one measurement in the 12 months prior to screening (Visit 1) AND a second raised value screening
* Have at least one random hGH level of ≥5 μg/L in the 12 months prior to screening AND a second raised value at screening
* Have given written informed consent
* Ability to comply with the requirements of the protocol for the study
Exclusion Criteria:
* Previous specific treatment for acromegaly in the 12 months prior to screening, including somatostatin analogues (SSAs); surgery; radiotherapy and pegvisomant
* Treatment with dopamine agonists in the 3 months prior to screening
* Uncontrolled hypertension
* Type I diabetes mellitus, poorly-controlled type II diabetes mellitus (glycosylated haemoglobin \[HbA1c\] ≥7.5%) and patients requiring insulin treatment
* Gallstones or gravel that could cause biliary obstruction
* Hyperprolactinaemia
* Participation in a clinical study within 60 days prior to screening
* Receipt of blood, blood products or plasma derivatives 60 days prior to screening
* Body mass index (BMI) below 22 or above 37 kg/m2
* Pregnancy, lactation or use of any hormonal based contraceptives
* Concomitant intake of corticosteroids or levodopa
* A history of active alcohol abuse or drug addiction
* Positive viral serology screening result for hepatitis B surface antigen, antibodies to hepatitis C virus, or human immunodeficiency virus type 1 and 2
* Evidence or suspicion of tumour expansion
* Clinically significant abnormality in screening ECG in the opinion of the Investigator
* Any clinically significant abnormal in screening laboratory safety test (biochemistry, haematology and dipstick urinalysis) in the opinion of the Investigator
* Any disease which in the Investigator's opinion would exclude the patient from the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02217800
Study Brief:
Protocol Section:
NCT02217800