Efficacy and Safety Study of Octreotide Implant in Patients With Acromegaly

Endo Pharmaceuticals

Status and phase

Terminated

Phase 3

Conditions

Acromegaly

Treatments

Drug: Octreotide Implant

Drug: Sandostatin LAR Depot

Study type

Interventional

Funder types

Industry

Identifiers

NCT00765323

IP107-001

Details and patient eligibility

About

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

Full 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.

Enrollment

169 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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