Assessment of the Ability of Subjects With Acromegaly or Their Partners to Administer Somatuline Autogel

Completed · Phase 3

Conditions studied: Acromegaly

In brief

The purpose of this study is to determine whether subjects with acromegaly (or their partners) are able to self administer Somatuline Autogel at home.

Key facts

Study ID

NCT00447499

Run by

Ipsen

People needed

59

Starts

2007-04-01

Expected to finish

2008-12-01

Last updated by the study team

2020-11-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The subject must give signed informed consent before any study-related activities.
• 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.

You may not qualify if…

• The subject has had pituitary surgery (adenomectomy) within 3 months prior to screening.
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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