- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01295060
Long-term Safety and Efficacy Study of Octreotide Implant in Patients With Acromegaly
September 17, 2013 updated by: Endo Pharmaceuticals
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
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
12
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Colorado
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Denver, Colorado, United States, 80220
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Illinois
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Chicago, Illinois, United States, 60611
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Maryland
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Baltimore, Maryland, United States, 21215
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Ohio
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Cleveland, Ohio, United States, 44195
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Oregon
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Portland, Oregon, United States, 97239
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Washington
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Seattle, Washington, United States, 98122
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Octreotide Implant
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84 mg Octreotide Implant
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Long term safety and tolerability of the Octreotide Implant
Time Frame: every 3 months for up to 2 years
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Subjects will be assessed every 3 months via adverse event reporting and examination of the implantation site
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every 3 months for up to 2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluate the long term efficacy of the Octreotide Implant
Time Frame: every 3 months for up to 2 years
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Patients will have GH and IGF-1 analyzed every 3 months
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every 3 months for up to 2 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2011
Primary Completion (Actual)
April 1, 2012
Study Completion (Actual)
June 1, 2012
Study Registration Dates
First Submitted
February 10, 2011
First Submitted That Met QC Criteria
February 10, 2011
First Posted (Estimate)
February 14, 2011
Study Record Updates
Last Update Posted (Estimate)
September 20, 2013
Last Update Submitted That Met QC Criteria
September 17, 2013
Last Verified
September 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Endocrine System Diseases
- Musculoskeletal Diseases
- Hypothalamic Diseases
- Bone Diseases
- Bone Diseases, Endocrine
- Hyperpituitarism
- Pituitary Diseases
- Acromegaly
- Antineoplastic Agents
- Gastrointestinal Agents
- Antineoplastic Agents, Hormonal
- Octreotide
Other Study ID Numbers
- EN3332-301
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Acromegaly
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Andrea M. IsidoriCompletedAcromegaly CardiomyopathyItaly
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Samsung Medical CenterNot yet recruitingAcromegaly Due to Pituitary AdenomaKorea, Republic of
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Istituto Auxologico ItalianoPolitecnico di MilanoRecruiting
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Camurus ABCompletedAcromegalyUnited States, Spain, United Kingdom, Germany, Russian Federation, Greece, Hungary, Italy, Poland, Turkey
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CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Completed
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IpsenCompletedAcromegalyGermany, Netherlands, Sweden, Czechia, Denmark, France, Greece, Italy, Spain, United Kingdom
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Novartis PharmaceuticalsCompletedAcromegalyItaly, Australia, Belgium, Germany, Switzerland, United States, France
-
Crinetics Pharmaceuticals Inc.CompletedAcromegalyUnited States, United Kingdom, Slovakia, Australia, Italy, Hungary, Brazil, Germany, Greece, New Zealand, Poland, Romania, Serbia
-
Chiasma, Inc.UnknownAcromegalyUnited States, Israel, Canada, Denmark, Netherlands, New Zealand, Australia, United Kingdom, Hungary, Italy, Poland, Bulgaria, Germany, Latvia, Slovenia, Sweden, Turkey
Clinical Trials on Octreotide
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AdventHealthTerminatedAdenomaUnited States
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Aspireo Pharmaceuticals LimitedCompleted
-
Mayo ClinicCompletedCirrhosis | Portal Hypertension | Esophageal Varices
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Chengfeng WangUnknown
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Novartis PharmaceuticalsCompletedChemotherapy-induced DiarrheaBrazil
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Qilu Pharmaceutical Co., Ltd.CompletedHealthy VolunteersChina
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Peking UniversityUnknownEsophageal Neuroendocrine Carcinoma | Gastro-entero-pancreatic CarcinomaChina
-
Qilu Hospital of Shandong UniversityNot yet recruitingNeuroendocrine TumorsChina
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Azidus BrasilSuspended
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Cliniques universitaires Saint-Luc- Université...TerminatedNeuroendocrine Tumors | Carcinoid Syndrome