Acromegaly
Conditions
Keywords
Acromegaly, Untreated, Newly diagnosed, Octreotide LAR, Pituitary surgery
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.
Interventions
DRUGOctreotide LAR
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean GH and IGF-I at baseline, week 12, 24 and 48 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Outcome results
None listed