acromegaly MedDRA version: 9.1 Level: LLT Classification code 10000599 Term: Acromegaly
Conditions
Interventions
Trade Name: DOSTINEX 2CPR 0,5MG
Pharmaceutical Form: Tablet
INN or Proposed INN: Cabergoline
CAS Number: 81409-90-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number:
Sponsors
NOVARTIS FARMA
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to investigate the efficacy of 8-months treatment of Sandostatin LAR High Dose monotherapy or Sandostatin LAR High Dose in combination either with GH antagonist or dopamine agonist to control both biochemical parameters GH and IGF-I in a large population of acromegalic patients not achieving biochemical normalization after at least 6 months of SSA at conventional regimen. 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.;Secondary Objective: Secondary objectives are to evaluate the efficacy of Sandostatin LAR High Dose 40 mg i.m. to wholly control biochemical parameters after 3 months of monotherapy Visit 2 to evaluate the efficacy of either SandostatinO LARO High Dose monotherapy or combination therapy arms to partially control biochemical parameters after 8- months of treatment to evaluate the effectiveness of either SandostatinO LARO High Dose monotherapy or combination therapies to relieve clinical signs and symptoms of acromegaly to evaluate changes in Quality of Life after either SandostatinO LARO High Dose monotherapy or combination therapies to evaluate the safety and tolerability of either SandostatinO LARO High Dose monotherapy and combination therapies;Primary end point(s): The primary efficacy variable is the Complete Response Rate CRR , defined as the total number of patients who will be Completely Responder at the end of 8-months treatment, whatever was the treatment . | — |
Countries
Italy, Portugal
Outcome results
None listed