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

September 7, 2005
June 18, 2012
February 2004
Not Provided
To assess the ability of patients or their partners to perform unsupervised Somatuline Autogel injections.
Same as current
Complete list of historical versions of study NCT00149188 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Somatuline Autogel: Acromegaly Self/Partner Injection Study
A Phase IV, Multicentre, Open Label, Controlled Study to Assess the Ability of Patients With Acromegaly, or Their Partners, to Administer Somatuline Autogel.

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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Acromegaly
Drug: Lanreotide (Autogel formulation)
Not Provided
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. Epub 2007 Sep 24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
Not Provided
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00149188
Y-97-52030-150
Not Provided
Ipsen
Ipsen
Not Provided
Study Director: UK Medical Director, MD Ipsen
Ipsen
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP