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
  Purpose

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
Acromegaly

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Ipsen:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 42
Study Start Date: July 2008
Study Completion Date: March 2013
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with Acromegaly seen in routine clinic

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00747500

Locations
United Kingdom
Aberdeen Royal Infirmary
Aberdeen, United Kingdom, AB25 2ZN
Barnsley General Hospital
Barnsley, United Kingdom
University Hospital Coventry & Warwickshire
Coventry, United Kingdom
Leeds General Infirmary
Leeds, United Kingdom
St Bartholomew's Hospital
London, United Kingdom
Manchester Royal Infirmary
Manchester, United Kingdom
Churchill Hospital
Oxford, United Kingdom
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Anne Fairey, MD Ipsen
  More Information

No publications provided

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT00747500     History of Changes
Other Study ID Numbers: Y-97-52030-213
Study First Received: September 4, 2008
Last Updated: April 22, 2013
Health Authority: United Kingdom: National Health Service

Additional relevant MeSH terms:
Acromegaly
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 21, 2014