Non Interventional Post Marketing Programme in Acromegaly

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Ipsen

ClinicalTrials.gov Identifier:

NCT00747500

First received: September 4, 2008

Last updated: April 22, 2013

Last verified: April 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

September 4, 2008

Last Updated Date

April 22, 2013

Start Date ^ICMJE

July 2008

Primary Completion Date

September 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

safety and local tolerability of Somatuline Autogel when administered by patients or their partners or from a healthcare professional [ Time Frame: End of observational period ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

To assess the safety and local tolerability of the long-term use of Somatuline Autogel when administered by patients or their partners and the safety and local tolerability in patients receiving their injection from a healthcare professional [ Time Frame: End of observational period ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00747500 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

efficacy of Somatuline Autogel in both groups [ Time Frame: End of observational period ] [ Designated as safety issue: No ]
training requirements for patients / partners to perform home injection of Somatuline Autogel [ Time Frame: End of observational period ] [ Designated as safety issue: No ]
acceptability of home injections to patients, partners and healthcare professionals [ Time Frame: End of observational period ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

To assess the efficacy of the long-term use of Somatuline Autogel in both groups [ Time Frame: End of observational period ] [ Designated as safety issue: No ]
To evaluate the training requirements for patients / partners to perform home injection of Somatuline Autogel [ Time Frame: End of observational period ] [ Designated as safety issue: No ]
To evaluate the acceptability of home injections to patients, partners and healthcare professionals [ Time Frame: End of observational period ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Non Interventional Post Marketing Programme in Acromegaly

Official Title ^ICMJE

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.

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").

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case Control
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Patients with Acromegaly seen in routine clinic

Condition ^ICMJE

Acromegaly

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

March 2013

Primary Completion Date

September 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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).

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00747500

Other Study ID Numbers ^ICMJE

Y-97-52030-213

Has Data Monitoring Committee

Responsible Party

Ipsen

Study Sponsor ^ICMJE

Ipsen

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Anne Fairey, MD

Ipsen

Information Provided By

Ipsen

Verification Date

April 2013

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

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