An open-label, two-step, multicenter European study to evaluate the efficacy and safety of Sandostatin LAR at High Dose or in combination either with GH-receptor antagonist or dopamine-agonist in acromegalic patients not adequately controlled by conventional regimen - ND

• Conditions: acromegaly; MedDRA version: 9.1Level: LLTClassification code 10000599Term: Acromegaly

• Registration Number: EUCTR2005-005852-42-IT
• Lead Sponsor: OVARTIS FARMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07-04
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Male or female patients aged 18 years. 2. Patient with biochemically documented active acromegaly, not adequately controlled by conventional regimen, as follows o mean 1-h GH 2.5 mg/L, according to Central Laboratory and o IGF-I above the upper limit of normal range, adjusted for age and gender, according to Central Laboratory range. Both tests should be documented by Central Laboratories and not older than 3-weeks from entry. 3. Patient has been receiving SSA at conventional regimen for at least 6 months prior to entry 8 Note for the purpose of this study, the definition of SSA at conventional regimen is - Sandostatin LAR octreotide at 30 mg every 28 days - Autogel lanreotide at 120 mg every 28 days 4. Patient with the reduction of either mean fasting GH at least 50 or IGF-I at least 25 from any medical pretreatment level 5. Patient with diagnosis of pituitary micro- or macroadenoma and independently from previous surgery 6. Written voluntary 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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Newly diagnosed or previously medically untreated acromegalic patient 2. Concomitant treatment with GH-receptor antagonist Note prior treatment with GH-antagonist is allowed providing a wash-out period of at least 8 weeks before inclusion 3. Concomitant treatment with dopamine-agonist Note prior treatment with dopamine-agonist is allowed providing a washout period of at least 6 weeks before inclusion 4. Symptomatic cholelithiasis or choledocolithiasis 5. Liver transaminases ALT, AST elevated, but 3 times upper normal limit according to local laboratory 6. Previous gamma-knife radiotherapy for treatment of acromegaly 8 Note previous conventional radiotherapy is allowed providing that it was stopped at least 3 weeks before inclusion 7. Compression of the optic chiasm causing visual field defect 8. Known hypersensitivity to any of the study drugs or to drugs with similar chemical structures 9. Any medical conditions contraindicated in the Summary of Product Characteristic SPC of all study drugs 10. Any current or prior medical condition that, in the judgment of the Investigator, may interfere with the conduct of the study or the evaluation of the study results. 11. Female patients who are pregnant or lactating or are of childbearing potential and not practicing a medically acceptable method for birth control. 12. Participation in investigational drug study within 30 days before inclusion. Patient must have recovered from all side effects of other investigational therapy 13. History of non-compliance to medical regimens, or patient who is considered potentially unreliable, or any circumstance at the time of study inclusion that would preclude completion of the entire study or the required follow up

Study & Design

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