Non Interventional Post Marketing Programme in Neuroendocrine Tumours - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 4, 2008

Last Updated Date

March 12, 2009

Start Date ^†

December 2008

Current 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: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00747786 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

efficacy of Somatuline Autogel [ 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 ^†

Same as current

Descriptive Information

Brief Title ^†

Non Interventional Post Marketing Programme in Neuroendocrine Tumours

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

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

Study Phase

Study Type ^†

Observational

Study Design ^†

Case Control, Prospective

Condition ^†

Neuroendocrine Tumors

Intervention ^†

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Estimated Enrollment ^†

Estimated Completion Date

March 2013

Estimated Primary Completion Date

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

Eligibility 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).

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Contact: Ipsen Recruitment Enquiries

clinical.trials@ipsen.com

Location Countries ^†

United Kingdom

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00747786

Responsible Party

Dr Robin Kingswell, Ipsen

Secondary IDs ^††

Study Sponsor ^†

Ipsen

Collaborators ^††

Investigators ^†

Study Director:

Robin Kingswell, MD

Ipsen

Information Provided By

Ipsen

Verification Date

March 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.