Somatuline Autogel Preference and Health Economy Study (SAPHE)

• 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: Ipsen
• Information provided by (Responsible Party): Ipsen

Study Description

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.

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 26 participants
• 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.
• Study Start Date: June 2008
• Actual Primary Completion Date: August 2010
• Actual Study Completion Date: August 2010

Arms and Interventions

Intervention Details:

• Drug: lanreotide (Autogel formulation)
  90 mg or 120 mg once every 28th day

Outcome Measures

Primary Outcome Measures :

1. 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 :

1. 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?'
2. 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?'
3. 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).
4. 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.
5. 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.
6. 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.
7. 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.

8. 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.

9. 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?

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• 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

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: Ipsen Medical Director; Ipsen

More Information

• Responsible Party: Ipsen
• ClinicalTrials.gov Identifier: NCT00681187
• Other Study ID Numbers: A-99-52030-216; 2007-006514-42 ( EudraCT Number )
• First Posted: May 21, 2008
• Results First Posted: March 13, 2012
• Last Update Posted: November 22, 2019
• Last Verified: November 2019

Additional relevant MeSH terms:

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Lanreotide; Antineoplastic Agents