acromegaly MedDRA version: 14.1 Level: PT Classification code 10000599 Term: Acromegaly System Organ Class: 10014698 - Endocrine disorders
Conditions
Interventions
Trade Name: Ipstyl 90 mg
Product Name: Ipstyl 90 mg
Pharmaceutical Form: Solution for injection
INN or Proposed INN: LANREOTIDE ACETATE
CAS Number: 127984-74-1
Other descriptive name: LANREOTIDE ACETA
Sponsors
AZIENDA OSPEDALIERA Spedali Civili di Brescia
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age> = 18 years Basal GH> = 1 microg / l, IGF1> 1.2 x ULN (age and sex) Ongoing treatment with lanreotide 120 mg every 4 weeks or octreotide 30 mg every 4 weeks for at least 6 months prior to randomization Reduction of GH> = 50% in the course of therapy with LLSSA to standard doses compared to pretreatment values Written informed consent 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 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: Symptomatic cholelithiasis Unstable angina, sustained ventricular tachycardia, ventricular fibrillation, or a history of acute myocardial infarction in the 3 months prior to enrollment. Liver disorders such as cirrhosis, chronic hepatitis, persistent rise in transaminase levels (AST, ALT, alkaline phosphatase 2 x ULN, total bilirubin 1.5 x ULN) or renal dysfunction (creatinine 1.5 x ULN) evaluated at screening; Radiotherapy performed in the 5 years prior to enrollment and surgery for acromegaly performed in the 6 months prior to enrollment Pregnant or breast-feeding women and women of childbearing age who do not adopt contraceptive methods. For women enrolled in the study, will require a negative urine pregnancy test at enrollment Concomitant treatment with drugs able to modify the secretion of GH or IGF-1, as eg. dopamine agonists and pegvisomant History of hypersensitivity to treatment with lanreotide At the time of screening, and / or enrollment, adverse events being considered related to treatment with SSA of severity greater than grade 1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: confirm efficacy and safety of treatment with lanreoride at doses increased and reduced time intervals between doses in patients with acromegaly poorly responsive to standard treatment;Secondary Objective: na;Primary end point(s): Biochemical control of acromegaly (IGF-I = 1.2 x ULN and basal GH <1 mg / L);Timepoint(s) of evaluation of this end point: After 24 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Number of serious and not serious adverse events ;Timepoint(s) of evaluation of this end point: For the entire duration of the study | — |
Countries
Italy
Contacts
Public ContactReparto Ricerca Clinica
GB Pharma Services & Consulting
Outcome results
None listed