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A Phase IV, International, Open-label, Randomised, Cross-over Study to Assess Patient Preference and Health Economy in Patients With Neuroendocrine Tumours, Treated With Lanreotide Autogel Given as Self Administration.


Phase 4
18 Years
N/A
Not Enrolling
Both
Neuroendocrine Tumour With Carcinoid Symptoms

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Trial Information

A Phase IV, International, Open-label, Randomised, Cross-over Study to Assess Patient Preference and Health Economy in Patients With Neuroendocrine Tumours, Treated With Lanreotide Autogel Given as Self Administration.


Inclusion Criteria:



- Provision of written informed consent from the patient and their partner (if the
partner will be administering the lanreotide Autogel injections during the self
administration period)

- Male or female aged 18 years of age or older

- Treated with lanreotide Autogel 90 or 120 mg every 28th day for carcinoid symptoms on
a stable dose for at least 3 months prior to inclusion. The patient is presumed to be
clinically stable during the coming months

- Neuroendocrine tumour confirmed by biopsy and visible on radiology

Exclusion Criteria:

- Has a history of hypersensitivity to the Investigational Medicinal Product or drugs
with a similar chemical structure

- Has abnormal baseline findings, any other medical condition(s) or laboratory findings
that, in the opinion of the Investigator, might jeopardise the patient's safety or
decrease the chance of obtaining satisfactory data needed to achieve the objective(s)
of the study

- Has a life expectancy less than a year, as judged by the Investigator

- The patient or their partner is not considered competent in injection technique, as
judged by the Investigator

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Subject Preference for Self or Partner Administration

Outcome Description:

A global question was asked: 'If you could choose, which administration method would you like to use on a regular basis?' A) Healthcare professional provided injection B) Self/ partner administered injection

Outcome Time Frame:

Between week 30 to 34

Safety Issue:

No

Principal Investigator

Viveka Aberg

Investigator Role:

Study Director

Investigator Affiliation:

Ipsen

Authority:

Sweden: Medical Products Agency

Study ID:

A-99-52030-216

NCT ID:

NCT00681187

Start Date:

June 2008

Completion Date:

August 2010

Related Keywords:

  • Neuroendocrine Tumour With Carcinoid Symptoms
  • Carcinoid Tumor
  • Neuroendocrine Tumors

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