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

NCT01295060 | Terminated Phase 3

• 1 other identifier: EN3332-301
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Acromegaly

Keywords

Acromegaly; Octreotide; IGF-1; Growth Hormone; Implant; Hydrogel

Outcome Measures

Primary Outcomes (1)

• Long term safety and tolerability of the Octreotide Implant

  Subjects will be assessed every 3 months via adverse event reporting and examination of the implantation site

  every 3 months for up to 2 years

Secondary Outcomes (1)

• Evaluate the long term efficacy of the Octreotide Implant

  every 3 months for up to 2 years

Study Arms (1)

Octreotide Implant

EXPERIMENTAL

Drug: Octreotide

Interventions

Octreotide DRUG

84 mg Octreotide Implant

Octreotide Implant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Endo Pharmaceuticals: lead

Study Sites (6)

Unknown Facility

Denver, Colorado, 80220, United States

Location

Unknown Facility

Chicago, Illinois, 60611, United States

Location

Unknown Facility

Baltimore, Maryland, 21215, United States

Location

Unknown Facility

Cleveland, Ohio, 44195, United States

Location

Unknown Facility

Portland, Oregon, 97239, United States

Location

Unknown Facility

Seattle, Washington, 98122, United States

Location

MeSH Terms

Conditions

Acromegaly

Interventions

Octreotide

Condition Hierarchy (Ancestors)

Bone Diseases, Endocrine; Bone Diseases; Musculoskeletal Diseases; Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2011
• First Posted: February 14, 2011
• Study Start: February 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: June 1, 2012
• Last Updated: September 20, 2013

Record last verified: 2013-09

Locations

US (6)