Non Interventional Post Marketing Programme in Neuroendocrine Tumours - Full Text View

Sponsored by:	Ipsen
Information provided by:	Ipsen
ClinicalTrials.gov Identifier:	NCT00747786

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
Neuroendocrine Tumors

MedlinePlus related topics: Cancer

Drug Information available for: Lanreotide acetate

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, 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 Neuroendocrine Tumours When Administered by Patients or Their Partners ("Home Injection Group") or Administered by Healthcare Professionals

Further study details as provided by Ipsen:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

To assess the efficacy of the long-term use of Somatuline Autogel [ 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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	50
Study Start Date:	September 2008
Estimated Study Completion Date:	March 2013
Estimated Primary Completion Date:	August 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 neuroendocrine tumours 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 PMS 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 neuroendocrine tumours
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 GP/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: NCT00747786

Contacts

Contact: Ipsen Recruitment Enquiries

clinical.trials@ipsen.com

Locations

United Kingdom
Royal Hallamshire Hospital
Sheffield, United Kingdom, S10 2JF

Sponsors and Collaborators

Ipsen

Investigators

Study Director:

Robin Kingswell, MD

Ipsen

More Information

Responsible Party:	Ipsen ( Dr Robin Kingswell )
Study ID Numbers:	Y-97-52030-215
Study First Received:	September 4, 2008
Last Updated:	September 4, 2008
ClinicalTrials.gov Identifier:	NCT00747786
Health Authority:	United Kingdom: National Health Service

Study placed in the following topic categories:

Neuroectodermal Tumors
Lanreotide
Neoplasms, Germ Cell and Embryonal

Angiopeptin
Neuroepithelioma
Neuroendocrine Tumors

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on January 14, 2009