Efficacy and Safety Study of Octreotide Implant in Patients With Acromegaly

• Status: Terminated
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Evaluate the efficacy, safety and tolerability of the octreotide implant in patients with acromegaly that were previously treated with octreotide depot.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Endo Pharmaceuticals
• Treatments: Octreotide; Somatostatin

Criteria

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