Acromegaly
Conditions
Keywords
Octreotide, Sandostatin LAR, Growth hormone, IGF-1
Brief summary
Evaluate the efficacy, safety and tolerability of the octreotide implant in patients with acromegaly that were previously treated with octreotide depot.
Detailed description
This study will be conducted in 3 phases: Screening, the Primary Treatment Phase (ie, Day 1 to Week 24), and the Extension Phase (Post Week 24 to Week 48). Primary efficacy and safety will be determined from the Primary Treatment Phase. Eligible patients will be randomized during the Primary Treatment Phase; in a 3 to 1 ratio to receive 6 months of open-label treatment with either the 84 mg octreotide implant or monthy Injections of S-LAR. Each patient in this study will return to the investigational center every 4 weeks; safety and efficacy assessments will be performed during these visits. All patients who complete the Primary Treatment Phase and who continue to meet eligibility criteria will be offered the opportunity to enter the Extension Phase; patients entering the Extension Phase will be treated with an octreotide implant for 6 months.During the Extension Phase, patients will return to the investigational center every 4 weeks; safety and efficacy assessments will be performed during these visits.
Interventions
DRUGOctreotide Implant
84 mg octreotide subcutaneous implant for 6 months
Injections of Sandostatin LAR (dose range \ 10-40 mg every 28 days)
Sponsors
Endo 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
* Male and female patients with acromegaly * Confirmed diagnosis of a growth hormone-secreting tumor * Received a stable dose of monthly octreotide depot injections for a minimum of 3 consecutive months immediately prior to screening * Must show a response to octreotide treatment with documented laboratory results at the screening visits defined as follows: IGF-1 \< 20% above the upper limit of normal age and sex-adjusted levels and GH ≤ 2.5 ng/mL
Exclusion criteria
* Patients with pituitary surgery less than 3 months prior to screening * Uncontrolled diabetes defined as having a fasting glucose \> 150 mg/dl and HbA1c \>= 9% * Symptomatic cholelithiasis * Received pegvisomant, Lanreotide, or a dopamine agonist within 3 months of screening, or at any time during the trial * Received radiotherapy for pituitary tumor or any radiotherapy above the neck at any time before Screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy based on IGF-1, GH, signs and symptoms scores, tumor size, QoL and Patient Treatment Assessments | 12 months |
Countries
Czechia, Germany, Hungary, Poland, Russia, Serbia, Slovakia, Spain, United States
Outcome results
None listed