Brief Title
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
Official Title
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
Brief Summary
This study will assess the efficacy of 8 months treatment of Sandostatin® LAR® High Dose monotherapy or Sandostatin® LAR® High Dose in combination either with growth hormone antagonist or dopamine agonist to control biochemical parameters (GH and insulin-like growth factor I [IGF I]) of acromegalic patients not achieving biochemical normalization at conventional regimen.
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
The Percentage of Participants With Complete Response (CR) at 8 Months
Secondary Outcome
The Percentage of Participants With Complete Response (CR) At 3 Months
Condition
Acromegaly
Intervention
Sandostatin LAR
Study Arms / Comparison Groups
Sandostatin LAR high dose Alone
Description: All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with controlled GH and IGF-I after 3 months of Sandostatin LAR monotherapy continued to receive Sandostatin LAR 40 mg i.m. every 28 days for an additional 4 months.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
70
Start Date
September 2006
Completion Date
November 2009
Primary Completion Date
November 2009
Eligibility Criteria
Inclusion Criteria: • Patient with a biochemically documented active acromegaly, not adequately controlled by somatostatin-analogues at conventional regimen as follow : mean 1-hour GH > 2.5 ng/mL and elevated IGF-1 (adjusted for age and gender) - Patient with reduction of either mean fasting GH at least 50% or IGF-1 at least 25% from any medical pretreatment level - Patient currently receiving somatostatin-analogues at conventional regimen (maximum registered dose) for at least 6 months before inclusion Exclusion Criteria: - Newly diagnosed or previously medically untreated acromegalic patient - Concomitant treatment with GH-receptor antagonist - Concomitant treatment with dopamine-agonist - Symptomatic cholelithiasis or choledocolithiasis - Liver transaminases (ALT, AST) elevated, but > 3 times upper normal limit (according to local laboratory) - Previous gamma-knife radiotherapy for treatment of acromegaly - Compression of the optic chiasm causing visual field defect - Any medical conditions contraindicated in the Summary of Product Characteristic (SPC) of all drugs Other protocol-defined inclusion/exclusion criteria may apply
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Novartis Pharmaceuticals, ,
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT01278342
Organization ID
CSMS995BIC03
Secondary IDs
2005-005852-42
Study Sponsor
Novartis Pharmaceuticals
Study Sponsor
Novartis Pharmaceuticals, Study Director, Novartis Pharmaceuticals
Verification Date
February 2017