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Sponsors and Collaborators: |
Tercica Ipsen |
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Information provided by: | Tercica |
ClinicalTrials.gov Identifier: | NCT00447499 |
The purpose of this study is to determine whether subjects with acromegaly (or their partners) are able to self administer Somatuline Autogel at home.
Condition | Intervention | Phase |
---|---|---|
Acromegaly |
Drug: Somatuline Autogel (lanreotide acetate) Behavioral: Home administration |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Multi Center Open Label Study to Assess the Ability of Subjects With Acromegaly or Their Partners to Administer Somatuline Autogel |
Enrollment: | 59 |
Study Start Date: | April 2007 |
Study Completion Date: | December 2008 |
Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Clinical experience with Somatuline Autogel to date has raised the possibility of self or partner injection. Previous microparticle somatostatin analogue formulations required careful reconstitution and as a result the cost of the analogues and the inconvenience of reconstitution meant self or partner injection was not a viable option.
Somatuline Autogel does not require reconstitution as it comes ready-mixed in a pre-filled syringe, thus making it more user-friendly than its predecessor and introducing the possibility of self or partner injection.
Patients with acromegaly often travel considerable distances every 28 days in order to receive their somatostatin analogue injections in the clinic. If Somatuline Autogel can be safely administered unsupervised, while maintaining disease control, this could offer patients considerable benefits in terms of reduced frequency of visits to the clinic.
This study is designed to allow suitably motivated patients with acromegaly or their partners to learn how to successfully inject Somatuline Autogel while maintaining their mean GH level control. Disease control in these patients will be assessed by comparing their GH and IGF-1 levels to accepted medical standards for control of acromegaly and by comparing the levels of GH and IGF-1 control achieved with baseline values.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Diabetes and Endocrine Associates | |
La Mesa, California, United States, 91942 | |
Cedars Sinai Medical Center | |
Los Angeles, California, United States, 90048 | |
United States, Colorado | |
Denver VA Medical Center | |
Denver, Colorado, United States, 80220 | |
United States, Illinois | |
Northwestern University The Feinberg School of Medicine | |
Chicago, Illinois, United States, 60611 | |
United States, Maryland | |
Johns Hopkins University | |
Baltimore, Maryland, United States, 21287 | |
United States, Massachusetts | |
Massachussetts General Hospital | |
Boston, Massachusetts, United States, 02114 | |
United States, New York | |
Columbia University | |
New York, New York, United States, 10032 | |
Sisters of Charity Hospital, Buffalo | |
Williamsville, New York, United States, 14221 | |
NYU School of Medicine | |
New York, New York, United States, 10010 | |
United States, Oregon | |
Oregon Health and Science University | |
Portland, Oregon, United States, 97239 | |
United States, Texas | |
Research Institute of Dallas | |
Dallas, Texas, United States, 75231 | |
University of Texas M.D. Anderson Cancer Center | |
Houston, Texas, United States, 77230 | |
Baylor College of Medicine | |
Houston, Texas, United States, 77030 |
Study Director: | Sandra L Blethen, M.D. PhD | Tercica, Inc. |
Responsible Party: | Tercica ( Sandra Blethen, MD, PhD ) |
Study ID Numbers: | MS315 |
Study First Received: | March 12, 2007 |
Last Updated: | December 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00447499 |
Health Authority: | United States: Food and Drug Administration |
Acromegaly Somatostatin Analogs Somatuline® Autogel® lanreotide growth hormone |
IGF-1 Inappropriate Growth Hormone Secretion Syndrome Somatotropin Hypersecretion Syndrome Inappropriate GH Secretion Syndrome |
Bone Diseases, Endocrine Hypothalamic Diseases Pituitary Diseases Central Nervous System Diseases Endocrine System Diseases Angiopeptin Brain Diseases |
Bone Diseases Somatostatin Lanreotide Musculoskeletal Diseases Endocrinopathy Acromegaly |
Hyperpituitarism Antineoplastic Agents Therapeutic Uses |
Nervous System Diseases Cardiovascular Agents Pharmacologic Actions |