Back to resultsSomatuline Autogel: Acromegaly Self/Partner Injection Study
Primary Purpose
Acromegaly
Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Lanreotide (Autogel formulation)
Sponsored by
About this trial
This is an interventional treatment trial for Acromegaly focused on measuring Growth Hormone
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
Sites / Locations
- Michael White Centre Diabetes & Endocrinology, Hull Royal Infirmary
- Department of Endocrinology, The Royal Free Hospital
- Dept of Endocrinology, Aberdeen Royal Infirmary
- Department of Medicine, Queen Elizabeth Hospital
- Department of Endocrinology, Coventry & Warwickshire Hospital
- Department of Endocrinology, Leicester Royal Infirmary
- Department of Endocrinology, Manchester Royal Infirmary
- The Oxford Centre for Diabetes, Endocrinology and Metabolism, The Churcill Hospital
- Department of Endocrinology, Royal Hallamshire Hospital
- Department of Endocrinology, Sunderland Royal Hospital
Outcomes
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00149188
Brief Title
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
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
August 24, 2005 (Actual)
Study Completion Date
August 24, 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ipsen
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acromegaly
Keywords
Growth Hormone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Lanreotide (Autogel formulation)
Primary Outcome Measure Information:
Title
To assess the ability of patients or their partners to perform unsupervised Somatuline Autogel injections.
Secondary Outcome Measure Information:
Title
To assess whether administration of unsupervised injections of Somatuline Autogel has any effect on GH and IGF-1 control or serum lanreotide levels.
Title
To assess patient/partner and healthcare professional experience with unsupervised injections.
Title
To assess the safety of patients or their partners performance of unsupervised Somatuline Autogel injections.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UK Medical Director, MD
Organizational Affiliation
Ipsen
Official's Role
Study Director
Facility Information:
Facility Name
Michael White Centre Diabetes & Endocrinology, Hull Royal Infirmary
City
Hull
State/Province
East Yorkshire
ZIP/Postal Code
HU3 2JZ
Country
United Kingdom
Facility Name
Department of Endocrinology, The Royal Free Hospital
City
Hampstead
State/Province
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
Dept of Endocrinology, Aberdeen Royal Infirmary
City
Aberdeen
ZIP/Postal Code
AB25 2ZN
Country
United Kingdom
Facility Name
Department of Medicine, Queen Elizabeth Hospital
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
Department of Endocrinology, Coventry & Warwickshire Hospital
City
Coventry
ZIP/Postal Code
CV1 4FH
Country
United Kingdom
Facility Name
Department of Endocrinology, Leicester Royal Infirmary
City
Leicester
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
Department of Endocrinology, Manchester Royal Infirmary
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Facility Name
The Oxford Centre for Diabetes, Endocrinology and Metabolism, The Churcill Hospital
City
Oxford
ZIP/Postal Code
OX3 7LJ
Country
United Kingdom
Facility Name
Department of Endocrinology, Royal Hallamshire Hospital
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom
Facility Name
Department of Endocrinology, Sunderland Royal Hospital
City
Sunderland
ZIP/Postal Code
SR4 7TP
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
17892497
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.
Results Reference
result
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Somatuline Autogel: Acromegaly Self/Partner Injection Study
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