A Multi Center Open Label Study to Assess the Ability of Subjects With Acromegaly or Their Partners to Administer Somatuline Autogel
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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The Percentage of Subjects or Their Partners That Are Competent to Self-administer Somatuline Autogel at the End of the Study, (Week 24/Early Termination), as Assessed by the Competence Questionnaire Score.
The primary efficacy endpoint was the percentage of patients (Switch and other) or their partners who were competent to self-administer lanreotide at the end of the study (Week 24/Early Termination), as assessed by the Assessment of Competence Questionnaire (0 = 'No' and 1 = 'Yes').
Sandra L Blethen, M.D. PhD
Ipsen (formerly Tercica)
United States: Food and Drug Administration
|Baylor College of Medicine||Houston, Texas 77030|
|Cedars Sinai Medical Center||Los Angeles, California 90048-1804|
|Johns Hopkins University||Baltimore, Maryland 21205|
|Columbia University||New York, New York 10032-3784|
|University of Texas M.D. Anderson Cancer Center||Houston, Texas 77030|
|Oregon Health and Science University||Portland, Oregon 97201|
|NYU School of Medicine||New York, New York 10016|
|Denver Va Medical Center||Denver, Colorado 80220|
|Diabetes and Endocrine Associates||La Mesa, California 91942|
|Northwestern University The Feinberg School of Medicine||Chicago, Illinois 60611|
|Massachussetts General Hospital||Boston, Massachusetts 02114|
|Sisters of Charity Hospital, Buffalo||Williamsville, New York 14221|
|Research Institute of Dallas||Dallas, Texas 75231|