Long-term Safety and Efficacy Study of Octreotide Implant in Patients With Acromegaly

Endo Pharmaceuticals

Status and phase

Terminated

Phase 3

Conditions

Acromegaly

Treatments

Drug: Octreotide

Study type

Interventional

Funder types

Industry

Identifiers

NCT01295060

EN3332-301

Details and patient eligibility

About

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.

Full description

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.

Enrollment

12 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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