Somatuline Autogel: Acromegaly Self/Partner Injection Study

Ipsen

Status and phase: Completed; Phase 4

Conditions: Acromegaly

Treatments: Drug: Lanreotide (Autogel formulation)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00149188

Y-97-52030-150

Details and patient eligibility

About

The purpose of this study is to allow patients with acromegaly, or their partners, to learn how to successfully inject Somatuline Autogel at home. Ability to perform unsupervised injections whilst maintaining adequate disease control will be assessed.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The patient must have a clinical diagnosis of acromegaly
• The patient must have been tested and shown to have a GH level less than or equal to 10 micrograms/L within 28 days prior to the baseline visit
• The patient must be currently treated with Somatuline Autogel and have been stable on their current dose for at least 6 months immediately prior to screening
• The patient must be able to store study medication in a refrigerator in their own home

Exclusion criteria

• The patient has had pituitary surgery (adenomectomy) within 6 months prior to screening
• The patient has received pituitary radiotherapy within one year prior to screening
• The patient is likely to require pituitary surgery (adenomectomy) or to receive radiotherapy during the study period
• The patient is currently receiving a GH antagonist or a somatostatin analogue other than Somatuline Autogel

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)