NCT00681187CompletedPhase 4
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.
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Ipsen
- Enrollment
- 26
- Locations
- 20
- Primary Endpoint
- Subject Preference for Self or Partner Administration
Study Overview
Brief Summary
The primary aim of this study is to assess which method of lanreotide Autogel administration patients with neuroendocrine tumours prefer - self/partner administrations or healthcare provided administrations. The study will also assess if self/partner administration can be performed without loss of efficacy and with a preserved safety profile. The impact of self/partner administration on resource utilisation and costs will be studied. In addition, we will also assess the healthcare provider's experience of the two administration practices.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Subject Preference for Self or Partner Administration
Time Frame: Between week 30 to 34
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
Secondary Outcomes
- Number of Patients Stating at Least One Injection Interfered With Daily Activities(Between baseline to week 32, after each injection (8-9 injections))
- Number of Patients Stating at Least One Injection Negatively Interfered With Psychological Wellbeing(Between baseline to week 32, after each injection (8-9 injections))
- Days Sick Leave(Group 1 - between week 8 to 20 (self or partner administration), between week 20 to 32 (HCP administration). Group 2 - between week 20 to 32 (self or partner administration), between week 0 to week 12 (HCP administration))
- Total Number of Visits to HCP Due to Carcinoid Symptoms(Group 1 - between week 8 to 20 (self or partner administration), between week 20 to 32 (HCP administration). Group 2 - between week 20 to 32 (self or partner administration), between week 0 to week 12 (HCP administration))
- Perceived Symptom Control Evaluation in Respect to Episodes of Flushing(Group 1 - baseline, week 16 to 20 (self or partner administration) and week 30 to 34 (HCP administration). Group 2 - baseline, week 12 (HCP administration) and week 30 (self or partner administration).)
- Perceived Symptom Control Evaluation in Respect to Episodes of Diarrhoea(Group 1 - baseline, week 16 to 20 (self or partner administration) and week 30 to 34 (HCP administration). Group 2 - baseline, week 12 to 16 (HCP administration) and week 30 to 34 (self or partner administration).)
- Chromogranin A Levels(Group 1 - Baseline, week 16 to 20 and 30 to 34. Group 2 - Baseline, week 12 and 30 to 34.)
- 5-hydroxyindoleacetic Acid (5-HIAA) Levels(Group 1 - Baseline, week 16 to 20 and 30 to 34. Group 2 - Baseline, week 12 and 30 to 34.)
- Healthcare Professionals With Positive Response to Specified Questions on Self or Partner Administration Method(Between week 30 to 34)
Investigators
Study Sites (20)
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