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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

September 4, 2008
April 22, 2013
July 2008
September 2012   (final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT00747500 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
Non Interventional Post Marketing Programme in Acromegaly
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.

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").

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
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Non-Probability Sample

Patients with Acromegaly seen in routine clinic

Acromegaly
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
March 2013
September 2012   (final data collection date for primary outcome measure)

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).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00747500
Y-97-52030-213
No
Ipsen
Ipsen
Not Provided
Study Director: Anne Fairey, MD Ipsen
Ipsen
April 2013

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