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

This study has been terminated.
(Program was terminated for business reasons)
Sponsor:
Information provided by (Responsible Party):
Endo Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01295060
First received: February 10, 2011
Last updated: September 17, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Acromegaly
Drug: Octreotide
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Endo Pharmaceuticals:

Primary Outcome Measures:
  • Long term safety and tolerability of the Octreotide Implant [ Time Frame: every 3 months for up to 2 years ] [ Designated as safety issue: Yes ]
    Subjects will be assessed every 3 months via adverse event reporting and examination of the implantation site


Secondary Outcome Measures:
  • Evaluate the long term efficacy of the Octreotide Implant [ Time Frame: every 3 months for up to 2 years ] [ Designated as safety issue: No ]
    Patients will have GH and IGF-1 analyzed every 3 months


Enrollment: 12
Study Start Date: February 2011
Study Completion Date: June 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Octreotide Implant Drug: Octreotide
84 mg 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01295060

Locations
United States, Colorado
Denver, Colorado, United States, 80220
United States, Illinois
Chicago, Illinois, United States, 60611
United States, Maryland
Baltimore, Maryland, United States, 21215
United States, Ohio
Cleveland, Ohio, United States, 44195
United States, Oregon
Portland, Oregon, United States, 97239
United States, Washington
Seattle, Washington, United States, 98122
Sponsors and Collaborators
Endo Pharmaceuticals
  More Information

No publications provided

Responsible Party: Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01295060     History of Changes
Other Study ID Numbers: EN3332-301
Study First Received: February 10, 2011
Last Updated: September 17, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Endo Pharmaceuticals:
Acromegaly
Octreotide
IGF-1
Growth Hormone
Implant
Hydrogel

Additional relevant MeSH terms:
Acromegaly
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Octreotide
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 27, 2014