Somatuline Autogel: Acromegaly Self/Partner Injection Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00149188
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : June 19, 2012
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Acromegaly Drug: Lanreotide (Autogel formulation) Phase 4

Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : February 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. To assess the ability of patients or their partners to perform unsupervised Somatuline Autogel injections.

Secondary Outcome Measures :
  1. To assess whether administration of unsupervised injections of Somatuline Autogel has any effect on GH and IGF-1 control or serum lanreotide levels.
  2. To assess patient/partner and healthcare professional experience with unsupervised injections.
  3. To assess the safety of patients or their partners performance of unsupervised Somatuline Autogel injections.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00149188

United Kingdom
Michael White Centre Diabetes & Endocrinology, Hull Royal Infirmary
Hull, East Yorkshire, United Kingdom, HU3 2JZ
Department of Endocrinology, The Royal Free Hospital
Hampstead, London, United Kingdom, NW3 2QG
Dept of Endocrinology, Aberdeen Royal Infirmary
Aberdeen, United Kingdom, AB25 2ZN
Department of Medicine, Queen Elizabeth Hospital
Birmingham, United Kingdom, B15 2TH
Department of Endocrinology, Coventry & Warwickshire Hospital
Coventry, United Kingdom, CV1 4FH
Department of Endocrinology, Leicester Royal Infirmary
Leicester, United Kingdom, LE1 5WW
Department of Endocrinology, Manchester Royal Infirmary
Manchester, United Kingdom, M13 9WL
The Oxford Centre for Diabetes, Endocrinology and Metabolism, The Churcill Hospital
Oxford, United Kingdom, OX3 7LJ
Department of Endocrinology, Royal Hallamshire Hospital
Sheffield, United Kingdom, S10 2JF
Department of Endocrinology, Sunderland Royal Hospital
Sunderland, United Kingdom, SR4 7TP
Sponsors and Collaborators
Study Director: UK Medical Director, MD Ipsen

Publications of Results:
Responsible Party: Ipsen Identifier: NCT00149188     History of Changes
Other Study ID Numbers: Y-97-52030-150
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: June 19, 2012
Last Verified: June 2012

Keywords provided by Ipsen:
Growth Hormone

Additional relevant MeSH terms:
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Antineoplastic Agents