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Somatuline Autogel: Acromegaly Self/Partner Injection Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT00149188
First received: September 7, 2005
Last updated: June 18, 2012
Last verified: June 2012
History of Changes
  Purpose

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 Intervention Phase
Acromegaly
 Drug: Lanreotide (Autogel formulation)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ipsen:

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

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

Estimated Enrollment: 30
Study Start Date: February 2004
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00149188

Locations
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
Ipsen
Investigators
Study Director: UK Medical Director, MD Ipsen
  More Information

Publications:

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT00149188     History of Changes
Other Study ID Numbers: Y-97-52030-150
Study First Received: September 7, 2005
Last Updated: June 18, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Ipsen:
Growth Hormone

Additional relevant MeSH terms:
Acromegaly
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Lanreotide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013