Non Interventional Post Marketing Programme in Acromegaly

Sponsor

Ipsen (Industry)

Overall Status

Completed

CT.gov ID

NCT00747500

Collaborator

(none)

Enrollment

Locations

Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study, is to assess the safety and local tolerability of the long-term use of Somatuline Autogel when administered by patients or their partners ("Home Injection Group") and the safety and local tolerability in patients receiving their injection from a healthcare professional (HCP) ("Reference Group").

Condition or Disease	Intervention/Treatment	Phase
Acromegaly

Study Design

Study Type:

Observational

Actual Enrollment :

42 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

An Observational, Multicentre, Open Label, Non Interventional Programme to Assess the Long-term Safety and Efficacy of Somatuline® Autogel® in the Treatment of Acromegaly When Administered by Patients or Their Partners ("Home Injection Group") or Administered by Healthcare Professionals.

Study Start Date :

Jul 1, 2008

Actual Primary Completion Date :

Sep 1, 2012

Actual Study Completion Date :

Mar 1, 2013

Outcome Measures

Primary Outcome Measures

safety and local tolerability of Somatuline Autogel when administered by patients or their partners or from a healthcare professional [End of observational period]

Secondary Outcome Measures

efficacy of Somatuline Autogel in both groups [End of observational period]
training requirements for patients / partners to perform home injection of Somatuline Autogel [End of observational period]
acceptability of home injections to patients, partners and healthcare professionals [End of observational period]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

The patient must give written (personally signed and dated) informed consent for their data to be included in the database for this post-marketing surveillance programme and any subsequent analysis.
The patient must have been receiving treatment with Somatuline Autogel at a stable dose for at least 4 months.
The patient must have a diagnosis of acromegaly.
The patient must be at least 18 years of age.
For patients receiving or intending to receive Somatuline Autogel by home injection:
The patient must be able to store Somatuline Autogel safely in a refrigerator in their own home and either collect it from their general practitioner/pharmacy on a monthly basis, or receive the medication by a home delivery service.

Exclusion Criteria:

The patient is pregnant or breast-feeding, unless continued treatment with Somatuline Autogel is clearly needed (as determined by the treating clinician).

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Aberdeen Royal Infirmary	Aberdeen	United Kingdom	AB25 2ZN
2	Barnsley General Hospital	Barnsley	United Kingdom
3	University Hospital Coventry & Warwickshire	Coventry	United Kingdom
4	Leeds General Infirmary	Leeds	United Kingdom
5	St Bartholomew's Hospital	London	United Kingdom
6	Manchester Royal Infirmary	Manchester	United Kingdom
7	Churchill Hospital	Oxford	United Kingdom

Sponsors and Collaborators

Ipsen

Investigators

Study Director: Ipsen Medical Director, Ipsen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ipsen

ClinicalTrials.gov Identifier:

NCT00747500

Other Study ID Numbers:

Y-97-52030-213

First Posted:

Sep 5, 2008

Last Update Posted:

Jan 7, 2019

Last Verified:

Jan 1, 2019

Additional relevant MeSH terms:

Acromegaly

Study Results

No Results Posted as of Jan 7, 2019