High-dose lanreotide in patients with acromegaly

• Conditions: acromegaly; MedDRA version: 14.1Level: PTClassification code 10000599Term: AcromegalySystem Organ Class: 10014698 - Endocrine disorders; Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

• Registration Number: EUCTR2012-005313-39-IT
• Lead Sponsor: AZIENDA OSPEDALIERA Spedali Civili di Brescia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03-20
• Last Update Posted: 11 April 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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