Clinical trial NCT00149188: Somatuline Autogel: Acromegaly Self/Partner Injection Study
Official title: A Phase IV, Multicentre, Open Label, Controlled Study to Assess the Ability of Patients With Acromegaly, or Their Partners, to Administer Somatuline Autogel.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acromegaly
Keywords: Growth Hormone
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2005-09-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: To assess the ability of patients or their partners to perform unsupervised Somatuline Autogel injections.
Secondary outcomes:
measure: To assess whether administration of unsupervised injections of Somatuline Autogel has any effect on GH and IGF-1 control or serum lanreotide levels.
measure: To assess patient/partner and healthcare professional experience with unsupervised injections.
measure: To assess the safety of patients or their partners performance of unsupervised Somatuline Autogel injections.
Other outcomes:
Locations:
city: Hull
country: United Kingdom
facility: Michael White Centre Diabetes & Endocrinology, Hull Royal Infirmary
state: East Yorkshire
city: Hampstead
country: United Kingdom
facility: Department of Endocrinology, The Royal Free Hospital
state: London
city: Aberdeen
country: United Kingdom
facility: Dept of Endocrinology, Aberdeen Royal Infirmary
city: Birmingham
country: United Kingdom
facility: Department of Medicine, Queen Elizabeth Hospital
city: Coventry
country: United Kingdom
facility: Department of Endocrinology, Coventry & Warwickshire Hospital
city: Leicester
country: United Kingdom
facility: Department of Endocrinology, Leicester Royal Infirmary
city: Manchester
country: United Kingdom
facility: Department of Endocrinology, Manchester Royal Infirmary
city: Oxford
country: United Kingdom
facility: The Oxford Centre for Diabetes, Endocrinology and Metabolism, The Churcill Hospital
city: Sheffield
country: United Kingdom
facility: Department of Endocrinology, Royal Hallamshire Hospital
city: Sunderland
country: United Kingdom
facility: Department of Endocrinology, Sunderland Royal Hospital
Study officials:
affiliation: Ipsen
name: UK Medical Director, MD
role: STUDY_DIRECTOR
References:
citation: Bevan JS, Newell-Price J, Wass JA, Atkin SL, Bouloux PM, Chapman J, Davis JR, Howlett TA, Randeva HS, Stewart PM, Viswanath A. Home administration of lanreotide Autogel by patients with acromegaly, or their partners, is safe and effective. Clin Endocrinol (Oxf). 2008 Mar;68(3):343-9. doi: 10.1111/j.1365-2265.2007.03044.x. Epub 2007 Sep 24.