Non Interventional Post Marketing Programme in Neuroendocrine Tumours
This study is ongoing, but not recruiting participants.
Sponsor:
Ipsen
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT00747786
First received: September 4, 2008
Last updated: March 31, 2013
Last verified: March 2013
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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 |
| 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 Neuroendocrine Tumours 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 [ 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: | 40 |
| Study Start Date: | December 2008 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | April 2013 (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 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 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
Locations
| United Kingdom | |
| University Hospital of Wales | |
| Cardiff, United Kingdom | |
| Aintree University Hospital | |
| Liverpool, United Kingdom | |
| St. Bartholomew's Hospital | |
| London, United Kingdom | |
| Royal Free Hospital | |
| London, United Kingdom | |
| Royal Hallamshire Hospital | |
| Sheffield, United Kingdom, S10 2JF | |
Sponsors and Collaborators
Ipsen
Investigators
| Study Director: | Anne Fairey, MD | Ipsen |
More Information
No publications provided
| Responsible Party: | Ipsen |
| ClinicalTrials.gov Identifier: | NCT00747786 History of Changes |
| Other Study ID Numbers: | Y-97-52030-215 |
| Study First Received: | September 4, 2008 |
| Last Updated: | March 31, 2013 |
| Health Authority: | United Kingdom: National Health Service |
Additional relevant MeSH terms:
|
Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue |
ClinicalTrials.gov processed this record on June 17, 2013