Clinical trial · Interventional
Somatuline Autogel Preference and Health Economy Study
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroendocrine Tumour With Carcinoid Symptoms | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| lanreotide (Autogel formulation) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Subject Preference for Self or Partner Administration
- timeFrame
- Between week 30 to 34
- 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
Secondary outcomes (9)
- measure
- Number of Patients Stating at Least One Injection Interfered With Daily Activities
- timeFrame
- Between baseline to week 32, after each injection (8-9 injections)
- description
- The subject was asked: 'Does the treatment administration used today interfere with your daily activities?'
- measure
- Number of Patients Stating at Least One Injection Negatively Interfered With Psychological Wellbeing
- timeFrame
- Between baseline to week 32, after each injection (8-9 injections)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available