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

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ipsen
• Treatments: Angiopeptin; Lanreotide; Somatostatin

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.