Long-term Safety and Efficacy Study of Octreotide Implant in Patients With Acromegaly
Long-term Safety and Efficacy Study of Octreotide Implant in Patients With Acromegaly
This is a long term study to evaluate the safety, tolerability and efficacy of an Octreotide
 Implant in patients that were previously treated with an Octreotide implant.
Evaluation on the long-term safety and tolerability, including local tolerability of the
 implant site, of the 84-mg octreotide hydrogel implant in subjects with acromegaly who had
 been successfully treated with the 84-mg octreotide hydrogel implant in the Phase III study
 IP107-001.
Inclusion Criteria:

 -  Currently enrolled in the Extension Phase of Study IP107-001 and received at least one
 84-mg octreotide hydrogel implant prior to enrollment OR previously enrolled in the
 Extension Phase of Study IP107-001 and currently taking lanreotide or octreotide.

 -  Subjects who have been successfully treated with the 84-mg octreotide hydrogel implant
 in Study IP107 001.

 -  In the opinion of the Investigator; subject has no unstable chronic medical conditions
 and no clinically significant findings that would preclude subject's participation in
 the study.

 -  Subjects must be able to communicate, provide and sign written informed consent, and
 be willing to participate and comply with study requirements.

 Exclusion Criteria:

 -  Pituitary surgery less than 3 months prior to enrollment into this study

 -  Liver disease (eg, cirrhosis, chronic active or persistent hepatitis or persistent
 abnormalities of ALT, AST [level >2× normal] or direct bilirubin [level >1.5× normal])

 -  Unstable angina, sustained ventricular arrhythmias or heart failure (NYHA III and IV)

 -  Acute myocardial infarction within 3 months of Screening

 -  Uncontrolled diabetes defined as having an HbA1c ≥9%

 -  Symptomatic cholelithiasis

 -  History of drug or alcohol abuse

 -  Received any investigational drug or participated in another clinical trial except for
 study IP107 001 within 30 days of enrollment into this study

 -  Received radiotherapy for pituitary tumor or any radiotherapy above the neck at any
 time prior to enrollment into this study

 -  Receiving pegvisomant, dopamine agonist or other therapy in combination with
 somatostatin to control GH or IGF-1 levels prior to enrollment into this study

 -  History or presence of significant cardiovascular, hepatic, renal, hematologic,
 gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychiatric
 disease, any other severe coexisting or, terminal systemic disease that limits life
 expectancy, or may interfere with the conduct of the study, or subjects who are
 incarcerated in penal institutions or are committed to mental institutions

 -  Women who are pregnant or lactating. For females of childbearing potential, a positive
 pregnancy test prior to enrollment, or an unwillingness to use accepted forms of
 reliable birth control for study duration (including bilateral tubal ligation, use of
 oral contraceptives, double barrier methods [diaphragm with spermicidal gel or condoms
 with contraceptive foam], Depo-Provera®, hormonal implants, partner vasectomy, and
 total abstinence). Pregnancy tests are not required (indicate "n/a") for males, or for
 females not of childbearing potential (post-menopausal with last menstrual period >1
 year ago or total hysterectomy with bilateral oophorectomy)

 -  An unwillingness on the part of a male subject to abstain from sexual intercourse with
 pregnant or lactating women or an unwillingness to use a condom and spermicide and
 another form of contraception (eg, IUD, birth control pills taken by female partner,
 diaphragm with spermicide) if engaging in sexual intercourse with a woman who could
 become pregnant until discharge from the study