A PHASE IV, 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

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2007-006514-42-SE
• Date of registration: 21/12/2007
• Prospective Registration: Yes
• Primary sponsor: Institut Produits Synthèse (IPSEN) AB
• Public title: A PHASE IV, 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
• Scientific title: A PHASE IV, 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
• Date of first enrolment: 23/01/2008
• Target sample size: 42
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-006514-42
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: yes Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: Administration by health care professional vs self/partner administration

Countries of recruitment

Denmark, Sweden

Key inclusion & exclusion criteria

Inclusion criteria:
(1) Provision of written informed consent. Provision of written informed consent by the patient’s partner if he/she will be administering the Somatuline Autogel injections during the self administration block.,
(2) Male or female aged 18 years of age or older,
(3) Treated with Somatuline Autogel 90 mg or120mg 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,
(4) Neuroendocrine tumour confirmed by biopsy and visible on radiology,
(5) Ability to store the study medication in a refrigerator at home.


Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
The presence of any of the following will exclude a patient from inclusion in the study:
(1) Has a history of hypersensitivity to lanreotide or drugs with a similar chemical structure,
(2) Has been treated with any other investigational medicinal product (IMP) within the last 3 months before study entry,
(3) Has a risk of pregnancy or performing lactation, or is likely to father a child during the study. Females of childbearing potential must provide a negative pregnancy test at start of study and must be using oral, double barrier or injectable contraception. (Non childbearing potential is defined as post-menopause for at least 1 year, surgical sterilisation or hysterectomy at least three months before the start of the study),
(4) Has a history of, or known current, problems with substance or alcohol abuse,
(5) Has any mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude,
(6) 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,
(7) Has a life expectancy less than a year, as judged by the Investigator,
(8) The patient or their partner is not considered competent in injection technique, as judged by the Investigator,
(9) The patient has previously entered this study.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Symptoms associated with carcinoid syndrome in patients with neuroendocrine tumours
MedDRA version: 9.1 Level: LLT Classification code 10007270 Term: Carcinoid syndrome

Intervention(s)

Trade Name: Somatuline Autogel
Pharmaceutical Form: Injection*
INN or Proposed INN: lanreotide
CAS Number: 108736352
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 90-
INN or Proposed INN: lanreotide
CAS Number: 108736352
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 120-

Primary Outcome(s)

Secondary Objective: To compare the two treatment administration groups with respect to:
-Health Economy
-Efficacy (symptom & biochemical control)
-Safety
-The healthcare provider´s experience of the patient’s lanreotide Autogel administration.

Main Objective: To assess the patient preference of two lanreotide Autogel administration practices; self/partner or healthcare professional administration.

Primary end point(s): The proportion of patients preferring self/partner administration healthcare professional administration at the last visit. A global question will be used. The question will be answered and recorded in the diary card by the patient.
The following question will be answered:
“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
Please give main reason:_____________________________________

Secondary ID(s)

A-99-52030-216