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Somatuline Autogel Preference and Health Economy Study (SAPHE)

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.
 
ClinicalTrials.gov Identifier: NCT00681187
Recruitment Status : Completed
First Posted : May 21, 2008
Results First Posted : March 13, 2012
Last Update Posted : November 22, 2019
Sponsor:
Information provided by (Responsible Party):
Ipsen

Tracking Information
First Submitted Date  ICMJE May 19, 2008
First Posted Date  ICMJE May 21, 2008
Results First Submitted Date  ICMJE September 1, 2011
Results First Posted Date  ICMJE March 13, 2012
Last Update Posted Date November 22, 2019
Study Start Date  ICMJE June 2008
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 9, 2012)
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
Original Primary Outcome Measures  ICMJE
 (submitted: May 20, 2008)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 9, 2012)
  • 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?
Original Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2008)
  • Patient evaluation questions regarding treatment administration experience [ Time Frame: After each injection (8-9 injections). ]
  • 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 ]
  • Perceived symptom control evaluation [ Time Frame: At each of the 3 study visits ]
  • Hormone level analysis [ Time Frame: At each of the 3 study visits ]
  • Adverse events and local tolerance evaluation [ Time Frame: After each injection (8-9 injections) ]
  • The healthcare professional's administration method preference will be measured by two global questions [ Time Frame: At visit 3 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Somatuline Autogel Preference and Health Economy Study
Official Title  ICMJE 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.
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neuroendocrine Tumour With Carcinoid Symptoms
Intervention  ICMJE Drug: lanreotide (Autogel formulation)
90 mg or 120 mg once every 28th day
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 29, 2010)
26
Original Estimated Enrollment  ICMJE
 (submitted: May 20, 2008)
42
Actual Study Completion Date  ICMJE August 2010
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark,   Norway,   Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00681187
Other Study ID Numbers  ICMJE A-99-52030-216
2007-006514-42 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ipsen
Study Sponsor  ICMJE Ipsen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ipsen Medical Director Ipsen
PRS Account Ipsen
Verification Date November 2019

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