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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Neuroendocrine Tumour With Carcinoid Symptoms
Intervention Drug: lanreotide (Autogel formulation)
Enrollment 26
Recruitment Details Data from ninety-four subjects was reviewed in hospital clinics in Denmark, Norway and Sweden. Of which 32 were ineligible, 36 were eligible but chose not to participate due to lack of motivation, satisfaction with current form of administration or fear of self-injection and 26 were included. Patients were recruited from Jun-08 to Jan-10.
Pre-assignment Details  
Arm/Group Title Group 1 Self or Partner First Then HCP Administration Group 2 HCP Then Self or Partner Administration
Hide Arm/Group Description Started with a training period where the subject or partner performed two or three training injections under supervision of a Healthcare Professional (HCP) at a healthcare provider facility. The training injections were followed by a self administration block of three subsequent unsupervised injections every 28th day at the subject’s home. A healthcare administration block followed the self administration block with three HCP provided injections according to clinical routine every 28th day. Started with a healthcare administration block with three HCP provided injections according to clinical routine every 28th day. A training period followed the healthcare administration block with two or three training injections performed by the subject or partner under supervision at the healthcare provider facilities. A self-administration block followed the training injections with 3 subsequent unsupervised injections every 28th day at the subject’s home. The subject visited the clinic for a follow-up visit 14 days after the last self-partner administered injection.
Period Title: Overall Study
Started 11 15
Completed 10 13
Not Completed 1 2
Reason Not Completed
Withdrawal by Subject             1             0
Death             0             1
Adverse Event             0             1
Arm/Group Title Group 1 Self or Partner First Then HCP Administration Group 2 HCP Then Self or Partner Administration Total
Hide Arm/Group Description Self or partner administration followed by HCP administration. Administration by HCP then self or partner administration. Total of all reporting groups
Overall Number of Baseline Participants 11 15 26
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 15 participants 26 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
6
  54.5%
8
  53.3%
14
  53.8%
>=65 years
5
  45.5%
7
  46.7%
12
  46.2%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants 15 participants 26 participants
63.2  (6.5) 60.0  (12.7) 61.4  (10.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 15 participants 26 participants
Female
4
  36.4%
8
  53.3%
12
  46.2%
Male
7
  63.6%
7
  46.7%
14
  53.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 11 participants 15 participants 26 participants
Denmark 3 4 7
Norway 1 3 4
Sweden 7 8 15
1.Primary Outcome
Title Subject Preference for Self or Partner Administration
Hide Description 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
Time Frame Between week 30 to 34
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Intention to Treat population defined as all randomised subjects with ≥ 1 dose of study medication and with a preference assessment recorded
Arm/Group Title Group 1 Self or Partner First Then HCP Administration Group 2 HCP Then Self or Partner Administration
Hide Arm/Group Description:
Self or Partner Administration followed by HCP Administration.
Administration by HCP then Self or Partner Administration.
Overall Number of Participants Analyzed 11 14
Measure Type: Number
Unit of Measure: participants
10 12
2.Secondary Outcome
Title Number of Patients Stating at Least One Injection Interfered With Daily Activities
Hide Description The subject was asked: 'Does the treatment administration used today interfere with your daily activities?'
Time Frame Between baseline to week 32, after each injection (8-9 injections)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Intention to Treat population defined as all randomised subjects with ≥ 1 dose of study medication and with a preference assessment recorded
Arm/Group Title Training Period Self or Partner Administration HCP Administration
Hide Arm/Group Description:
The training period was where the subject or partner performed two or three training injections under supervision of a HCP at a healthcare provider facility.
The self or partner administration block (after training period) included three unsupervised injections every 28th day at the subject’s home.
A healthcare administration block included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
Overall Number of Participants Analyzed 25 25 25
Measure Type: Number
Unit of Measure: Participants
6 2 6
3.Secondary Outcome
Title Number of Patients Stating at Least One Injection Negatively Interfered With Psychological Wellbeing
Hide Description The subject was asked: 'Does the treatment administration used today negatively interfere with your psychological wellbeing?'
Time Frame Between baseline to week 32, after each injection (8-9 injections)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Intention to Treat population defined as all randomised subjects with ≥ 1 dose of study medication and with a preference assessment recorded
Arm/Group Title Training Period Self or Partner Administration HCP Administration
Hide Arm/Group Description:
The training period was where the subject or partner performed two or three training injections under supervision of a HCP at a healthcare provider facility.
The self or partner administration block (after training period) included three unsupervised injections every 28th day at the subject’s home.
A healthcare administration block included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
Overall Number of Participants Analyzed 25 25 25
Measure Type: Number
Unit of Measure: participants
4 2 1
4.Secondary Outcome
Title Days Sick Leave
Hide Description 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).
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)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population: all randomised subjects with at least one dose of study medication. Two of the six subjects reported sick leave during the study. One subject was absent for one day due to unknown reason, the other was absent for 22 days due to surgery of metastasis.
Arm/Group Title Self or Partner Administration HCP Administration
Hide Arm/Group Description:
The self or partner administration block (after the training period) included three unsupervised injections every 28th day at the subject's home.
A healthcare administration block included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
Overall Number of Participants Analyzed 6 6
Measure Type: Number
Unit of Measure: days
23 0
5.Secondary Outcome
Title Total Number of Visits to HCP Due to Carcinoid Symptoms
Hide Description 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.
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)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population: all randomised subjects with at least one dose of study medication
Arm/Group Title Self or Partner Administration HCP Administration
Hide Arm/Group Description:
The self or partner administration block (after the training) included three unsupervised injections every 28th day at the subject's home.
A healthcare administration block included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
Overall Number of Participants Analyzed 12 12
Measure Type: Number
Unit of Measure: visits
17 25
6.Secondary Outcome
Title Perceived Symptom Control Evaluation in Respect to Episodes of Flushing
Hide Description 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.
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).
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Intention to Treat population defined as all randomised subjects with ≥ 1 dose of study medication and with a preference assessment recorded.
Arm/Group Title Baseline Self or Partner Administration HCP Administration
Hide Arm/Group Description:
Baseline refers to the last non-study visit at the clinic.
The self or partner administration block (after training period) included three unsupervised injections every 28th day at the subject's home.
A healthcare administration block included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
Overall Number of Participants Analyzed 25 25 25
Measure Type: Number
Unit of Measure: participants
Worsened 0 1 1
Similar 24 21 20
Improved 1 2 4
Missing 0 1 0
7.Secondary Outcome
Title Perceived Symptom Control Evaluation in Respect to Episodes of Diarrhoea
Hide Description 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.
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).
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Intention to Treat population defined as all randomised subjects with ≥ 1 dose of study medication and with a preference assessment recorded.
Arm/Group Title Baseline Self or Partner Administration HCP Administration
Hide Arm/Group Description:
Baseline refers to the last non-study visit at the clinic.
The self or partner administration block (after training period) included three unsupervised injections every 28th day at the subject's home.
A healthcare administration block included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
Overall Number of Participants Analyzed 25 25 25
Measure Type: Number
Unit of Measure: participants
Worsened 1 4 0
Similar 22 17 24
Improved 2 3 1
Missing 0 1 0
8.Secondary Outcome
Title Chromogranin A Levels
Hide Description

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.
Time Frame Group 1 - Baseline, week 16 to 20 and 30 to 34. Group 2 - Baseline, week 12 and 30 to 34.
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population that had hormone levels assessed at each administration block.
Arm/Group Title Before Self or Partner Administration After Self or Partner Administration Before HCP Administration After HCP Administration
Hide Arm/Group Description:
Before self or partner administration block (after training period) which included three unsupervised injections every 28th day at the subject's home.
After the self or partner administration block which included three unsupervised injections every 28th day at the subject's home.
Before the healthcare administration block which included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
After the healthcare administration block which included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
Overall Number of Participants Analyzed 22 22 22 22
Mean (Standard Deviation)
Unit of Measure: nmol/l
37.48  (58.35) 47.85  (74.89) 42.05  (70.74) 37.42  (57.96)
9.Secondary Outcome
Title 5-hydroxyindoleacetic Acid (5-HIAA) Levels
Hide Description

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.
Time Frame Group 1 - Baseline, week 16 to 20 and 30 to 34. Group 2 - Baseline, week 12 and 30 to 34.
Hide Outcome Measure Data
Hide Analysis Population Description
5-HIAA were assessed as judged necessary by the investigator at each site.
Arm/Group Title Before Self or Partner Administration After Self or Partner Administration Before HCP Administration After HCP Administration
Hide Arm/Group Description:
Before self or partner administration block (after training period) which included three unsupervised injections every 28th day at the subject's home.
After the self or partner administration block which included three unsupervised injections every 28th day at the subject's home.
Before the healthcare administration block which included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
After the healthcare administration block which included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
Overall Number of Participants Analyzed 12 12 12 12
Mean (Standard Deviation)
Unit of Measure: nmol/l
220.17  (238.32) 219.17  (227.64) 217.08  (244.32) 219.58  (218.51)
10.Secondary Outcome
Title Healthcare Professionals With Positive Response to Specified Questions on Self or Partner Administration Method
Hide Description

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?
Time Frame Between week 30 to 34
Hide Outcome Measure Data
Hide Analysis Population Description
One HCP from each site who enrolled participants replied to the question
Arm/Group Title Overall Study Group
Hide Arm/Group Description:
One HCP from each site who enrolled participants answered the questions
Overall Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: participants
9
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Training Period Self or Partner Administration HCP Administration
Hide Arm/Group Description The training period was where the subject or partner performed two or three training injections under supervision of a HCP at a healthcare provider facility. The self or partner administration block (after training period) included three unsupervised injections every 28th day at the subject’s home. A healthcare administration block included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
All-Cause Mortality
Training Period Self or Partner Administration HCP Administration
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
Training Period Self or Partner Administration HCP Administration
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/26 (15.38%)      4/26 (15.38%)      3/26 (11.54%)    
Cardiac disorders       
Atrial fibrillation *  0/26 (0.00%)  0 1/26 (3.85%)  1 0/26 (0.00%)  0
Gastrointestinal disorders       
Abdominal pain *  0/26 (0.00%)  0 1/26 (3.85%)  1 0/26 (0.00%)  0
Ileus *  2/26 (7.69%)  2 0/26 (0.00%)  0 0/26 (0.00%)  0
Peritoneal cyst *  1/26 (3.85%)  1 0/26 (0.00%)  0 0/26 (0.00%)  0
Subileus *  0/26 (0.00%)  0 0/26 (0.00%)  0 1/26 (3.85%)  1
General disorders       
Death *  1/26 (3.85%)  1 0/26 (0.00%)  0 0/26 (0.00%)  0
Disease progression *  0/26 (0.00%)  0 1/26 (3.85%)  1 0/26 (0.00%)  0
Hepatobiliary disorders       
Cholangitis *  0/26 (0.00%)  0 0/26 (0.00%)  0 1/26 (3.85%)  2
Infections and infestations       
Biliary tract infection *  1/26 (3.85%)  1 0/26 (0.00%)  0 0/26 (0.00%)  0
Infection *  0/26 (0.00%)  0 0/26 (0.00%)  0 1/26 (3.85%)  1
Injury, poisoning and procedural complications       
Post procedural fistula *  1/26 (3.85%)  1 0/26 (0.00%)  0 0/26 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Dyspnoea *  0/26 (0.00%)  0 1/26 (3.85%)  1 0/26 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Training Period Self or Partner Administration HCP Administration
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/26 (26.92%)      4/26 (15.38%)      7/26 (26.92%)    
Gastrointestinal disorders       
Nausea *  3/26 (11.54%)  4 1/26 (3.85%)  1 0/26 (0.00%)  0
General disorders       
Disease progression *  0/26 (0.00%)  0 1/26 (3.85%)  2 2/26 (7.69%)  2
Injection site pain *  4/26 (15.38%)  4 1/26 (3.85%)  3 3/26 (11.54%)  6
Nervous system disorders       
Headache *  3/26 (11.54%)  4 1/26 (3.85%)  1 0/26 (0.00%)  0
Vascular disorders       
Flushing *  0/26 (0.00%)  0 1/26 (3.85%)  2 2/26 (7.69%)  2
*
Indicates events were collected by non-systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Director, Endocrinology
Organization: Ipsen
Phone: clinical.trials@ipsen.com
EMail: clinical.trials@ipsen.com
Layout table for additonal information
Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT00681187    
Other Study ID Numbers: A-99-52030-216
2007-006514-42 ( EudraCT Number )
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: November 22, 2019