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

Brief Title

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

Official Title

PHASE IIIB, OPEN-LABEL, MULTICENTER STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF AN 84-MG OCTREOTIDE SUBCUTANEOUS HYDROGEL IMPLANT IN SUBJECTS WITH ACROMEGALY

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.
    

Detailed 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.
    

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

Long term safety and tolerability of the Octreotide Implant

Secondary Outcome

 Evaluate the long term efficacy of the Octreotide Implant

Condition

Acromegaly

Intervention

Octreotide

Study Arms / Comparison Groups

 Octreotide Implant

Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

12

Start Date

February 2011

Completion Date

June 2012

Primary Completion Date

April 2012

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

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Location Countries

United States

Location Countries

United States

NCT ID

NCT01295060

Organization ID

EN3332-301

Responsible Party

Sponsor

Study Sponsor

Endo Pharmaceuticals

Study Sponsor

, , 

Verification Date

September 2013