Somatuline Autogel: Acromegaly Self/Partner Injection Study

Acromegaly Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00149188
• Other study ID #: Y-97-52030-150
• Status: Completed
• Phase: Phase 4
• Start date: February 2004
• Est. completion date: August 24, 2005

Study information

• Verified date: August 2019
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 24, 2005
• Est. primary completion date: August 24, 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acromegaly

Intervention

Drug:
• Lanreotide (Autogel formulation)

Locations

Country	Name	City	State
United Kingdom	Dept of Endocrinology, Aberdeen Royal Infirmary	Aberdeen
United Kingdom	Department of Medicine, Queen Elizabeth Hospital	Birmingham
United Kingdom	Department of Endocrinology, Coventry & Warwickshire Hospital	Coventry
United Kingdom	Department of Endocrinology, The Royal Free Hospital	Hampstead	London
United Kingdom	Michael White Centre Diabetes & Endocrinology, Hull Royal Infirmary	Hull	East Yorkshire
United Kingdom	Department of Endocrinology, Leicester Royal Infirmary	Leicester
United Kingdom	Department of Endocrinology, Manchester Royal Infirmary	Manchester
United Kingdom	The Oxford Centre for Diabetes, Endocrinology and Metabolism, The Churcill Hospital	Oxford
United Kingdom	Department of Endocrinology, Royal Hallamshire Hospital	Sheffield
United Kingdom	Department of Endocrinology, Sunderland Royal Hospital	Sunderland

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the ability of patients or their partners to perform unsupervised Somatuline Autogel injections.
Secondary	To assess whether administration of unsupervised injections of Somatuline Autogel has any effect on GH and IGF-1 control or serum lanreotide levels.
Secondary	To assess patient/partner and healthcare professional experience with unsupervised injections.
Secondary	To assess the safety of patients or their partners performance of unsupervised Somatuline Autogel injections.