Acromegaly MedDRA version: 9.1 Level: LLT Classification code 10000599 Term: Acromegaly
Conditions
Interventions
Product Name: OCTREOTIDE ACETATE
Product Code: C2L-OCT-01 PR , 20mg
Pharmaceutical Form: Powder for suspension for injection
INN or Proposed INN: OCTREOTIDE
CAS Number: 83150769
Concentration unit: mg
Sponsors
Ambrilia Biopharma Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients who have completed the 24 week study C2L-OCT-01 PR-301 (protocol version 3, 8-May-2007). • Women of childbearing potential must have a negative pregnancy test prior to start of study medication. • Having the ability to understand the requirements of the study, provide written informed consent to participate in this study and agree to abide by the study restrictions. 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Female patients of childbearing potential age who are not using adequate contraception. (i.e. oral or trans-dermal contraceptive drugs, intra-uterine device, diaphragm) • Pregnant or lactating female patients. • Having experienced any clinically significant adverse event related to study medication in the C2L-OCT-01 PR-301 (version 3, 8 May 2007). • Patients with uncontrolled Diabetes type II as indicated by the presence of ketoacidosis or HbA1C = 10%. • Presenting clinically significant signs and symptoms potentially related to a tumor compression of the optical chiasm, based on judgment of the investigator. • Patients with symptomatic cholelithiasis. • Presenting clinically serious and/or unstable intercurrent infection, medical illnesses or conditions that are uncontrolled or whose control, in the opinion of the Investigator, may be jeopardized by participation in this study or by the complications of this therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess for an additional 24 weeks, the safety profile of C2L-OCT-01 PR administered intra muscularly every 6 weeks in patients who have completed the C2L-OCT-01 PR-301 study.;Secondary Objective: - To determine the percentage of patients who remain with controlled mean GH and normal (gender and age matched values) IGF-1 serum concentrations. - To measure the octreotide plasma concentrations prior to, and 2 hours after C2L-OCT-01 PR administration. - To assess the acromegaly severity score index and patient's health status. - To evaluate pituitary tumor size during C2L-OCT-01 PR treatment;Primary end point(s): The primary safety endpoints are: • Incidence/severity of treatment-emergent adverse events. • Serial vital signs (blood pressure, heart rate) and ECG monitoring. • Echocardiography and gallbladder ultrasound evaluations. • Serial physical examinations. • Serial laboratory evaluations including fasting glucose two hours after study medication administration. | — |
Countries
Hungary
Outcome results
None listed