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
  Purpose

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.


Condition Intervention Phase
Neuroendocrine Tumour With Carcinoid Symptoms
Drug: lanreotide (Autogel formulation)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Ipsen:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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?


Enrollment: 26
Study Start Date: June 2008
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: lanreotide (Autogel formulation)
    90 mg or 120 mg once every 28th day
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00681187

Locations
Denmark
Aarhus University Hospital / Medisinsk afd. V
Aarhus, Denmark, 8000
Odense Univeristy Hospital / S-AMB
Odense, Denmark, 5000
Norway
Haukeland University Hospital / Kreftafd
Bergen, Norway, 5021
University Hospital North-Norway / GastroLab
Tromsø, Norway, 9038
S:t Olavs Hospital / Medisinsk Afd
Trondheim, Norway, 7006
Sweden
Sahlgrenska University Hospital / Kirurgkliniken
Gothenburg, Sweden, 413 45
Linköping University Hospital / Onkologen
Linköping, Sweden, 581 85
Karolinska University Hospital, Solna / Kirurgmottagningen
Stockholm, Sweden, 171 76
Karolinska University Hospital, Huddinge / GastroCentrum Medicin
Stockholm, Sweden, 141 86
Akademiska Hospital/ Kliniken f onkologisk endokrinologi
Uppsala, Sweden, 752 85
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Viveka Aberg Ipsen
  More Information

No publications provided

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT00681187     History of Changes
Other Study ID Numbers: A-99-52030-216
Study First Received: May 19, 2008
Results First Received: September 1, 2011
Last Updated: February 9, 2012
Health Authority: Sweden: Medical Products Agency
Norway: Norwegian Medicines Agency
Denmark: Danish Medicines Agency

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Angiopeptin
Lanreotide
Antineoplastic Agents
Cardiovascular Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014