Brief Title
Safety and Efficacy of Long-acting Repeatable Octreotide Acetate for Injectable Suspension vs. Surgery in Treatment-naïve Patients With Acromegaly
Official Title
Safety and Efficacy of Long-acting Repeatable Octreotide Acetate for Injectable Suspension vs. Surgery in Treatment-naïve Patients With Acromegaly
Brief Summary
Currently, the first line treatment for acromegaly is surgery, in order to remove the adenoma causing overproduction of growth hormone which leads to acromegaly. The objective of this study is to assess the safety and efficacy of long-acting repeatable formulation of octreotide and to compare it to the safety and efficacy of surgery in patients with acromegaly who have not had any previous treatment for acromegaly.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Mean GH and IGF-I at baseline, week 12, 24 and 48
Secondary Outcome
Tumor volume at baseline, week 24 and 48
Condition
Acromegaly
Intervention
Octreotide LAR
Study Arms / Comparison Groups
SMS995
Description:
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
100
Start Date
November 2002
Completion Date
March 2005
Primary Completion Date
March 2005
Eligibility Criteria
Inclusion Criteria: - Newly diagnosed or previously untreated acromegalic patients - Lack of suppression of GH nadir to <1.0 µg/L, after oral administration of 75 g of glucose (OGTT) - IGF-I levels above the upper limits of normal, i.e. 97th percentile (adjusted for age and gender) Exclusion Criteria: - Requires surgery for recent significant deterioration in visual fields or other neurological signs, which are related to the pituitary tumor mass - No evidence of pituitary adenoma on Magnetic Resonance Imaging (MRI) - Symptomatic cholelithiasis Other protocol-defined exclusion criteria may apply.
Gender
All
Ages
18 Years - 80 Years
Accepts Healthy Volunteers
No
Contacts
Novartis Pharmaceuticals, ,
Administrative Informations
NCT ID
NCT00225979
Organization ID
CSMS995B2402
Responsible Party
Sponsor
Study Sponsor
Novartis Pharmaceuticals
Study Sponsor
Novartis Pharmaceuticals, Study Director, Novartis Pharmaceuticals
Verification Date
April 2012