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Somatuline Autogel Preference and Health Economy Study (SAPHE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT00681187
First received: May 19, 2008
Last updated: February 9, 2012
Last verified: February 2012

May 19, 2008
February 9, 2012
June 2008
August 2010   (final data collection date for primary outcome measure)
Subject Preference for Self or Partner Administration [ Time Frame: Between week 30 to 34 ] [ Designated as safety issue: No ]
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
A global question will be used to assess the patient's administration method preference [ Time Frame: At the follow-up visit, two weeks after the last administration ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00681187 on ClinicalTrials.gov Archive Site
  • Number of Patients Stating at Least One Injection Interfered With Daily Activities [ Time Frame: Between baseline to week 32, after each injection (8-9 injections) ] [ Designated as safety issue: No ]
    The subject was asked: 'Does the treatment administration used today interfere with your daily activities?'
  • Number of Patients Stating at Least One Injection Negatively Interfered With Psychological Wellbeing [ Time Frame: Between baseline to week 32, after each injection (8-9 injections) ] [ Designated as safety issue: No ]
    The subject was asked: 'Does the treatment administration used today negatively interfere with your psychological wellbeing?'
  • Days Sick Leave [ Time Frame: 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) ] [ Designated as safety issue: No ]
    Health care and patient costs associated with the treatment of carcinoid symptoms in subjects treated with lanreotide Autogel were assessed through recording loss of production for subject through total number of days sick leave of the employed patients (n=6).
  • Total Number of Visits to HCP Due to Carcinoid Symptoms [ Time Frame: 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) ] [ Designated as safety issue: No ]
    Health care and patient costs associated with the treatment of carcinoid symptoms in subjects treated with lanreotide Autogel were assessed by recording the total number of visits made by participants (n=12) to HCP due to carcinoid symptoms.
  • Perceived Symptom Control Evaluation in Respect to Episodes of Flushing [ Time Frame: 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). ] [ Designated as safety issue: No ]
    Participants were asked how they perceived the symptoms in respect to episodes of flushing since the last injection. Participants included in the study were previously treated with lanreotide Autogel and therefore the assessment at baseline was made in comparison to their previous injection outside of the study protocol.
  • Perceived Symptom Control Evaluation in Respect to Episodes of Diarrhoea [ Time Frame: 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). ] [ Designated as safety issue: No ]
    Participants were asked how they perceived the symptoms in respect to episodes of diarrhoea since the last injection. Participants included in the study were previously treated with lanreotide autogel and therefore the assessment at baseline was made in comparison to previous injection outside of the study protocol.
  • Chromogranin A Levels [ Time Frame: Group 1 - Baseline, week 16 to 20 and 30 to 34. Group 2 - Baseline, week 12 and 30 to 34. ] [ Designated as safety issue: No ]

    Biochemical control was assessed by analysing chromogranin A levels at each site visit, which was mandatory for all subjects.

    'Before self or partner administration' was assessed at baseline for group 1 and at week 12 for group 2.

    'After self or partner administration' was assessed at week 16 to 20 for group 1 and at week 12 for group 2.

    'Before HCP administration' was assessed at week 16 to 20 for group 1 and at baseline for group 2.

    'After HCP administration' was assessed at week 30 to 34 for group 1 and week 12 for group 2.

  • 5-hydroxyindoleacetic Acid (5-HIAA) Levels [ Time Frame: Group 1 - Baseline, week 16 to 20 and 30 to 34. Group 2 - Baseline, week 12 and 30 to 34. ] [ Designated as safety issue: No ]

    Biochemical control was assessed by analysing 5-HIAA levels at each site visit, which was judged as necessary by the investigator at each site.

    'Before self or partner administration' was assessed at baseline for group 1 and at week 12 for group 2.

    'After self or partner administration' was assessed at week 16 to 20 for group 1 and at week 12 for group 2.

    'Before HCP administration' was assessed at week 16 to 20 for group 1 and at baseline for group 2.

    'After HCP administration' was assessed at week 30 to 34 for group 1 and week 12 for group 2.

  • Healthcare Professionals With Positive Response to Specified Questions on Self or Partner Administration Method [ Time Frame: Between week 30 to 34 ] [ Designated as safety issue: No ]

    Assessed by the number of HCP with a positive response 'yes' to two questions:

    1. Based on your experience during this trial, did you feel confident in the safety of your patients?
    2. Based on your experience during this trial, would you recommend suitable patients to try self or partner administration?
  • Patient evaluation questions regarding treatment administration experience [ Time Frame: After each injection (8-9 injections). ] [ Designated as safety issue: No ]
  • Health care and patient costs, i.e. selected direct and indirect costs associated with the treatment of carcinoid symptoms [ Time Frame: At each of the 3 study visits ] [ Designated as safety issue: No ]
  • Perceived symptom control evaluation [ Time Frame: At each of the 3 study visits ] [ Designated as safety issue: No ]
  • Hormone level analysis [ Time Frame: At each of the 3 study visits ] [ Designated as safety issue: No ]
  • Adverse events and local tolerance evaluation [ Time Frame: After each injection (8-9 injections) ] [ Designated as safety issue: Yes ]
  • The healthcare professional's administration method preference will be measured by two global questions [ Time Frame: At visit 3 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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.

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Neuroendocrine Tumour With Carcinoid Symptoms
Drug: lanreotide (Autogel formulation)
90 mg or 120 mg once every 28th day
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
August 2010
August 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark,   Norway,   Sweden
 
NCT00681187
A-99-52030-216
No
Ipsen
Ipsen
Not Provided
Study Director: Viveka Aberg Ipsen
Ipsen
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP