Assessment of the Ability of Subjects With Acromegaly or Their Partners to Administer Somatuline Autogel
NCT ID: NCT00447499
Last Updated: 2020-11-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
59 participants
INTERVENTIONAL
2007-04-30
2008-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Somatuline Autogel (lanreotide acetate)
Somatuline Autogel (lanreotide acetate) Injection
Somatuline Autogel (lanreotide acetate)
Injections
Home administration
Questionnaire
Interventions
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Somatuline Autogel (lanreotide acetate)
Injections
Home administration
Questionnaire
Eligibility Criteria
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Inclusion Criteria
* The partner, if applicable, must give signed informed consent before administration of Somatuline Autogel.
* The subject must be able to understand the protocol requirements.
* The subject must have a clinical diagnosis of acromegaly due to pituitary tumor.
* The subject must be treated with a long-acting somatostatin analogue with or without a dopamine agonist and have been on the current medical regimen for at least 3 months prior to screening and have IGF-1 levels no higher than 10% above the upper limit of the normal range for age and gender at the screening visit or be somatostatin analogue naïve (if the subject is treated with a dopamine agonist he/she must have been on the current dose for at least 3 months prior to screening).
* Subjects who are treated with a dopamine agonist have to stay on their current dose for the duration of the study.
* Switch subjects must have had their last pre-study routine clinical treatment with Sandostatin LAR between 28 and 35 days before Visit 2 (enrollment).
* The subject must be able to store the study medication in a refrigerator in his/her own or his/her partner's home.
* The subject must be ≥18 years of age.
* Female subjects of childbearing potential must use adequate contraception.
* Female subjects of childbearing potential who are taking oral contraceptives must agree to stay on their current contraceptive dose for the duration of the study.
* The partner, if applicable, must be ≥18 years of age.
Exclusion Criteria
* The subject has received pituitary radiotherapy within 3 years prior to screening.
* The subject has received a GH receptor antagonist within 6 months prior to screening.
* The subject is currently on a higher dose of Sandostatin LAR than 30mg q28d
* The subject is pregnant or breastfeeding.
* The subject has clinically significant renal or hepatic abnormalities.
* The subject has a symptomatic, untreated biliary lithiasis.
* The subject has uncontrolled diabetes or thyroid disease.
* The subject has a known hypersensitivity to any of the test materials or related compounds.
* The subject is unable or unwilling to comply with the protocol.
* The subject has received any investigational drug within 30 days prior to screening.
* The subject has participated in a medical device study within 30 days prior to screening.
* The subject has previously participated in this study.
18 Years
ALL
No
Sponsors
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Ipsen
INDUSTRY
Responsible Party
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Principal Investigators
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Ipsen Medical Director
Role: STUDY_DIRECTOR
Ipsen (formerly Tercica)
Locations
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Diabetes and Endocrine Associates
La Mesa, California, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
Denver VA Medical Center
Denver, Colorado, United States
Northwestern University The Feinberg School of Medicine
Chicago, Illinois, United States
Johns Hopkins University
Baltimore, Maryland, United States
Massachussetts General Hospital
Boston, Massachusetts, United States
NYU School of Medicine
New York, New York, United States
Columbia University
New York, New York, United States
Sisters of Charity Hospital, Buffalo
Williamsville, New York, United States
Oregon Health and Science University
Portland, Oregon, United States
Research Institute of Dallas
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States
Countries
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References
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Salvatori R, Nachtigall LB, Cook DM, Bonert V, Molitch ME, Blethen S, Chang S; SALSA Study Group. Effectiveness of self- or partner-administration of an extended-release aqueous-gel formulation of lanreotide in lanreotide-naive patients with acromegaly. Pituitary. 2010 Jun;13(2):115-22. doi: 10.1007/s11102-009-0207-x.
Other Identifiers
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MS315
Identifier Type: -
Identifier Source: org_study_id