Safety and Efficacy of Long-acting Repeatable Octreotide Acetate for Injectable Suspension vs. Surgery in Treatment-naïve Patients With Acromegaly
- Registration Number
- NCT00225979
- Lead Sponsor
- Novartis Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SMS995 Octreotide LAR -
- Primary Outcome Measures
Name Time Method Mean GH and IGF-I at baseline, week 12, 24 and 48
- Secondary Outcome Measures
Name Time Method Tumor volume at baseline, week 24 and 48 Signs and symptoms of acromegaly at baseline, week 12, 24 and 48 Quality of life and sleep apnea at baseline, week 12, 24 and 48 Safety and tolerability at any time on treatment