Acromegaly MedDRA version: 16.0 Level: PT Classification code 10000599 Term: Acromegaly System Organ Class: 10014698 - Endocrine disorders
Conditions
Interventions
Product Name: Octreolin
Pharmaceutical Form: Capsule
CAS Number: 79517-01-4
Other descriptive name: OCTREOTIDE ACETATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration numbe
Sponsors
Chiasma, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Adult subjects, aged 18 to 75 years old, inclusive, at screening visits 2.Subjects with acromegaly defined as documented evidence of GH-secreting pituitary tumor that is abnormally responsive to glucose who are currently receiving somatostatin analog. 3.Subjects able and willing to comply with the requirements of the protocol 4.Subjects able to swallow capsules 5.Subjects able to understand and sign written informed consent to participate in the study 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 132 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 18
Exclusion criteria
Exclusion criteria: 1.Symptomatic cholelithiasis 2.Received pituitary radiotherapy within ten years prior to screening 3.Undergone pituitary surgery within the prior 6 months 4.Clinically significant GI, renal or hepatic disease. 5.Known allergy or hypersensitivity to any of the test compounds or materials 6.Life expectancy of less than 2 years 7.Uncontrolled diabetes 8.Defects in visual fields due to optic chiasmal compression 9.Female patients who are pregnant or lactating 10.Female patients who are of childbearing potential 11.History of immunocompromise, including a positive HIV test result (ELISA and Western blot) 12.History of alcohol or drug abuse 13.Intake of an investigational drug within 30 days before patient inclusion in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the effect of Octreolin therapy on Insulin-like Growth Factor 1 (IGF-1) levels ;Secondary Objective: To determine the effect of Octreolin therapy on Growth Hormone (GH) levels To assess the safety and tolerability of Octreolin in subjects with acromegaly ;Primary end point(s): The primary efficacy endpoint is the IGF-1 concentration at the end of the Core Treatment Period. ;Timepoint(s) of evaluation of this end point: End of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary efficacy endpoints is the GH concentration at the completion of the Treatment Period. The secondary safety endpoint is the safety and tolerability during the Treatment Period.;Timepoint(s) of evaluation of this end point: End of treatment | — |
Countries
Germany, Hungary, Israel, Italy, Lithuania, Mexico, Netherlands, Poland, Romania, Serbia, Slovakia, Slovenia, United Kingdom
Contacts
Public ContactMedpace Regulatory Submissions
Medpace, Inc.
Outcome results
None listed