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Non Interventional Post Marketing Programme in Neuroendocrine Tumours

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00747786
Recruitment Status : Completed
First Posted : September 5, 2008
Last Update Posted : January 7, 2019
Sponsor:
Information provided by (Responsible Party):
Ipsen

Tracking Information
First Submitted Date September 4, 2008
First Posted Date September 5, 2008
Last Update Posted Date January 7, 2019
Study Start Date December 2008
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 12, 2009)
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 ]
Original Primary Outcome Measures
 (submitted: September 4, 2008)
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 ]
Change History Complete list of historical versions of study NCT00747786 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 12, 2009)
  • efficacy of Somatuline Autogel [ Time Frame: End of observational period ]
  • training requirements for patients / partners to perform home injection of Somatuline Autogel [ Time Frame: End of observational period ]
  • acceptability of home injections to patients, partners and healthcare professionals [ Time Frame: End of observational period ]
Original Secondary Outcome Measures
 (submitted: September 4, 2008)
  • To assess the efficacy of the long-term use of Somatuline Autogel [ Time Frame: End of observational period ]
  • To evaluate the training requirements for patients / partners to perform home injection of Somatuline Autogel [ Time Frame: End of observational period ]
  • To evaluate the acceptability of home injections to patients, partners and healthcare professionals [ Time Frame: End of observational period ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with neuroendocrine tumours seen in routine clinic
Condition Neuroendocrine Tumors
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 20, 2011)
40
Original Estimated Enrollment
 (submitted: September 4, 2008)
50
Actual Study Completion Date August 2013
Actual Primary Completion Date April 2013   (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 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).
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT00747786
Other Study ID Numbers Y-97-52030-215
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Ipsen
Study Sponsor Ipsen
Collaborators Not Provided
Investigators
Study Director: Ipsen Medical Director Ipsen
PRS Account Ipsen
Verification Date January 2019