Brief Title
Safety and Efficacy of Octreotide Long Acting Release (LAR) in Treatment Naïve Acromegalic Patients
Official Title
Safety and Efficacy of Octreotide LAR in Treatment Naïve Acromegalic Patients
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. Octreotide LAR is approved for treatment of acromegaly after surgery if the disease is not controlled. This study was aimed to test the safety and efficacy of octreotide LAR in acromegalic patients who did not have 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
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
December 2002
Primary Completion Date
August 2004
Eligibility Criteria
Inclusion Criteria: - Newly diagnosed or previously untreated acromegalic patients - Lack of suppression of growth hormone (GH) nadir to <1.0 µg/L, after oral administration of 75g of glucose (oral glucose tolerance test [OGTT]) - Insulin-like growth factor-I (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
Gender
All
Ages
18 Years - 80 Years
Contacts
Stephan Petersenn, MD, ,
Administrative Informations
NCT ID
NCT00128232
Organization ID
CSMS995B2401
Responsible Party
Sponsor
Study Sponsor
Novartis
Study Sponsor
Stephan Petersenn, MD, Principal Investigator, Universität Duisburg-Essen
Verification Date
April 2012