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Somatuline Autogel Preference and Health Economy Study (SAPHE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00681187
First Posted: May 21, 2008
Last Update Posted: March 13, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ipsen
  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
Intervention Model: Crossover Assignment
Masking: None (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 ]
    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) ]
    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) ]
    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) ]
    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) ]
    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). ]
    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). ]
    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. ]

    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. ]

    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 ]

    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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, Huddinge / GastroCentrum Medicin
Stockholm, Sweden, 141 86
Karolinska University Hospital, Solna / Kirurgmottagningen
Stockholm, Sweden, 171 76
Akademiska Hospital/ Kliniken f onkologisk endokrinologi
Uppsala, Sweden, 752 85
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Viveka Aberg Ipsen
  More Information

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT00681187     History of Changes
Other Study ID Numbers: A-99-52030-216
First Submitted: May 19, 2008
First Posted: May 21, 2008
Results First Submitted: September 1, 2011
Results First Posted: March 13, 2012
Last Update Posted: March 13, 2012
Last Verified: February 2012

Additional relevant MeSH terms:
Neuroendocrine Tumors
Carcinoid Tumor
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Lanreotide
Angiopeptin
Antineoplastic Agents