Trial Outcomes & Findings for Somatuline Autogel Preference and Health Economy Study (NCT NCT00681187)
NCT ID: NCT00681187
Last Updated: 2019-11-22
Results Overview
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
COMPLETED
PHASE4
26 participants
Between week 30 to 34
2019-11-22
Participant Flow
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.
Participant milestones
| Measure |
Group 1 Self or Partner First Then HCP Administration
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.
|
Group 2 HCP Then Self or Partner Administration
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.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
15
|
|
Overall Study
COMPLETED
|
10
|
13
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Group 1 Self or Partner First Then HCP Administration
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.
|
Group 2 HCP Then Self or Partner Administration
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
Somatuline Autogel Preference and Health Economy Study
Baseline characteristics by cohort
| Measure |
Group 1 Self or Partner First Then HCP Administration
n=11 Participants
Self or partner administration followed by HCP administration.
|
Group 2 HCP Then Self or Partner Administration
n=15 Participants
Administration by HCP then self or partner administration.
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Age, Continuous
|
63.2 years
STANDARD_DEVIATION 6.5 • n=99 Participants
|
60.0 years
STANDARD_DEVIATION 12.7 • n=107 Participants
|
61.4 years
STANDARD_DEVIATION 10.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Region of Enrollment
Denmark
|
3 participants
n=99 Participants
|
4 participants
n=107 Participants
|
7 participants
n=206 Participants
|
|
Region of Enrollment
Norway
|
1 participants
n=99 Participants
|
3 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Region of Enrollment
Sweden
|
7 participants
n=99 Participants
|
8 participants
n=107 Participants
|
15 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Between week 30 to 34Population: 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
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
Outcome measures
| Measure |
Group 1 Self or Partner First Then HCP Administration
n=11 Participants
Self or Partner Administration followed by HCP Administration.
|
Group 2 HCP Then Self or Partner Administration
n=14 Participants
Administration by HCP then Self or Partner Administration.
|
HCP Administration
A healthcare administration block included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
|
After HCP Administration
After the healthcare administration block which included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
|
|---|---|---|---|---|
|
Subject Preference for Self or Partner Administration
|
10 participants
Interval 58.7 to 99.8
|
12 participants
Interval 57.2 to 98.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Between baseline to week 32, after each injection (8-9 injections)Population: 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
The subject was asked: 'Does the treatment administration used today interfere with your daily activities?'
Outcome measures
| Measure |
Group 1 Self or Partner First Then HCP Administration
n=25 Participants
Self or Partner Administration followed by HCP Administration.
|
Group 2 HCP Then Self or Partner Administration
n=25 Participants
Administration by HCP then Self or Partner Administration.
|
HCP Administration
n=25 Participants
A healthcare administration block included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
|
After HCP Administration
After the healthcare administration block which included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
|
|---|---|---|---|---|
|
Number of Patients Stating at Least One Injection Interfered With Daily Activities
|
6 Participants
|
2 Participants
|
6 Participants
|
—
|
SECONDARY outcome
Timeframe: Between baseline to week 32, after each injection (8-9 injections)Population: 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
The subject was asked: 'Does the treatment administration used today negatively interfere with your psychological wellbeing?'
Outcome measures
| Measure |
Group 1 Self or Partner First Then HCP Administration
n=25 Participants
Self or Partner Administration followed by HCP Administration.
|
Group 2 HCP Then Self or Partner Administration
n=25 Participants
Administration by HCP then Self or Partner Administration.
|
HCP Administration
n=25 Participants
A healthcare administration block included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
|
After HCP Administration
After the healthcare administration block which included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
|
|---|---|---|---|---|
|
Number of Patients Stating at Least One Injection Negatively Interfered With Psychological Wellbeing
|
4 participants
|
2 participants
|
1 participants
|
—
|
SECONDARY outcome
Timeframe: 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)Population: 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.
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).
Outcome measures
| Measure |
Group 1 Self or Partner First Then HCP Administration
n=6 Participants
Self or Partner Administration followed by HCP Administration.
|
Group 2 HCP Then Self or Partner Administration
n=6 Participants
Administration by HCP then Self or Partner Administration.
|
HCP Administration
A healthcare administration block included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
|
After HCP Administration
After the healthcare administration block which included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
|
|---|---|---|---|---|
|
Days Sick Leave
|
23 days
|
0 days
|
—
|
—
|
SECONDARY outcome
Timeframe: 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)Population: Safety population: all randomised subjects with at least one dose of study medication
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.
Outcome measures
| Measure |
Group 1 Self or Partner First Then HCP Administration
n=12 Participants
Self or Partner Administration followed by HCP Administration.
|
Group 2 HCP Then Self or Partner Administration
n=12 Participants
Administration by HCP then Self or Partner Administration.
|
HCP Administration
A healthcare administration block included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
|
After HCP Administration
After the healthcare administration block which included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
|
|---|---|---|---|---|
|
Total Number of Visits to HCP Due to Carcinoid Symptoms
|
17 visits
|
25 visits
|
—
|
—
|
SECONDARY outcome
Timeframe: 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).Population: 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.
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.
Outcome measures
| Measure |
Group 1 Self or Partner First Then HCP Administration
n=25 Participants
Self or Partner Administration followed by HCP Administration.
|
Group 2 HCP Then Self or Partner Administration
n=25 Participants
Administration by HCP then Self or Partner Administration.
|
HCP Administration
n=25 Participants
A healthcare administration block included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
|
After HCP Administration
After the healthcare administration block which included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
|
|---|---|---|---|---|
|
Perceived Symptom Control Evaluation in Respect to Episodes of Flushing
Worsened
|
0 participants
|
1 participants
|
1 participants
|
—
|
|
Perceived Symptom Control Evaluation in Respect to Episodes of Flushing
Similar
|
24 participants
|
21 participants
|
20 participants
|
—
|
|
Perceived Symptom Control Evaluation in Respect to Episodes of Flushing
Improved
|
1 participants
|
2 participants
|
4 participants
|
—
|
|
Perceived Symptom Control Evaluation in Respect to Episodes of Flushing
Missing
|
0 participants
|
1 participants
|
0 participants
|
—
|
SECONDARY outcome
Timeframe: 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).Population: 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.
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.
Outcome measures
| Measure |
Group 1 Self or Partner First Then HCP Administration
n=25 Participants
Self or Partner Administration followed by HCP Administration.
|
Group 2 HCP Then Self or Partner Administration
n=25 Participants
Administration by HCP then Self or Partner Administration.
|
HCP Administration
n=25 Participants
A healthcare administration block included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
|
After HCP Administration
After the healthcare administration block which included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
|
|---|---|---|---|---|
|
Perceived Symptom Control Evaluation in Respect to Episodes of Diarrhoea
Worsened
|
1 participants
|
4 participants
|
0 participants
|
—
|
|
Perceived Symptom Control Evaluation in Respect to Episodes of Diarrhoea
Similar
|
22 participants
|
17 participants
|
24 participants
|
—
|
|
Perceived Symptom Control Evaluation in Respect to Episodes of Diarrhoea
Missing
|
0 participants
|
1 participants
|
0 participants
|
—
|
|
Perceived Symptom Control Evaluation in Respect to Episodes of Diarrhoea
Improved
|
2 participants
|
3 participants
|
1 participants
|
—
|
SECONDARY outcome
Timeframe: Group 1 - Baseline, week 16 to 20 and 30 to 34. Group 2 - Baseline, week 12 and 30 to 34.Population: ITT population that had hormone levels assessed at each administration block.
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.
Outcome measures
| Measure |
Group 1 Self or Partner First Then HCP Administration
n=22 Participants
Self or Partner Administration followed by HCP Administration.
|
Group 2 HCP Then Self or Partner Administration
n=22 Participants
Administration by HCP then Self or Partner Administration.
|
HCP Administration
n=22 Participants
A healthcare administration block included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
|
After HCP Administration
n=22 Participants
After the healthcare administration block which included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
|
|---|---|---|---|---|
|
Chromogranin A Levels
|
37.48 nmol/l
Standard Deviation 58.35 • Interval 11.61 to 63.35
|
47.85 nmol/l
Standard Deviation 74.89 • Interval 14.65 to 81.05
|
42.05 nmol/l
Standard Deviation 70.74 • Interval 10.69 to 73.41
|
37.42 nmol/l
Standard Deviation 57.96 • Interval 11.72 to 63.11
|
SECONDARY outcome
Timeframe: Group 1 - Baseline, week 16 to 20 and 30 to 34. Group 2 - Baseline, week 12 and 30 to 34.Population: 5-HIAA were assessed as judged necessary by the investigator at each site.
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.
Outcome measures
| Measure |
Group 1 Self or Partner First Then HCP Administration
n=12 Participants
Self or Partner Administration followed by HCP Administration.
|
Group 2 HCP Then Self or Partner Administration
n=12 Participants
Administration by HCP then Self or Partner Administration.
|
HCP Administration
n=12 Participants
A healthcare administration block included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
|
After HCP Administration
n=12 Participants
After the healthcare administration block which included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
|
|---|---|---|---|---|
|
5-hydroxyindoleacetic Acid (5-HIAA) Levels
|
220.17 nmol/l
Standard Deviation 238.32 • Interval 68.75 to 371.59
|
219.17 nmol/l
Standard Deviation 227.64 • Interval 74.53 to 363.8
|
217.08 nmol/l
Standard Deviation 244.32 • Interval 61.85 to 372.32
|
219.58 nmol/l
Standard Deviation 218.51 • Interval 80.75 to 358.42
|
SECONDARY outcome
Timeframe: Between week 30 to 34Population: One HCP from each site who enrolled participants replied to the question
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?
Outcome measures
| Measure |
Group 1 Self or Partner First Then HCP Administration
n=9 Participants
Self or Partner Administration followed by HCP Administration.
|
Group 2 HCP Then Self or Partner Administration
Administration by HCP then Self or Partner Administration.
|
HCP Administration
A healthcare administration block included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
|
After HCP Administration
After the healthcare administration block which included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
|
|---|---|---|---|---|
|
Healthcare Professionals With Positive Response to Specified Questions on Self or Partner Administration Method
|
9 participants
Interval 66.4 to 100.0
|
—
|
—
|
—
|
Adverse Events
Training Period
Self or Partner Administration
HCP Administration
Serious adverse events
| Measure |
Training Period
n=26 participants at risk
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.
|
Self or Partner Administration
n=26 participants at risk
The self or partner administration block (after training period) included three unsupervised injections every 28th day at the subject's home.
|
HCP Administration
n=26 participants at risk
A healthcare administration block included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/26
|
3.8%
1/26 • Number of events 1
|
0.00%
0/26
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/26
|
3.8%
1/26 • Number of events 1
|
0.00%
0/26
|
|
Infections and infestations
Biliary tract infection
|
3.8%
1/26 • Number of events 1
|
0.00%
0/26
|
0.00%
0/26
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/26
|
0.00%
0/26
|
3.8%
1/26 • Number of events 2
|
|
General disorders
Death
|
3.8%
1/26 • Number of events 1
|
0.00%
0/26
|
0.00%
0/26
|
|
General disorders
Disease progression
|
0.00%
0/26
|
3.8%
1/26 • Number of events 1
|
0.00%
0/26
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/26
|
3.8%
1/26 • Number of events 1
|
0.00%
0/26
|
|
Gastrointestinal disorders
Ileus
|
7.7%
2/26 • Number of events 2
|
0.00%
0/26
|
0.00%
0/26
|
|
Infections and infestations
Infection
|
0.00%
0/26
|
0.00%
0/26
|
3.8%
1/26 • Number of events 1
|
|
Gastrointestinal disorders
Peritoneal cyst
|
3.8%
1/26 • Number of events 1
|
0.00%
0/26
|
0.00%
0/26
|
|
Injury, poisoning and procedural complications
Post procedural fistula
|
3.8%
1/26 • Number of events 1
|
0.00%
0/26
|
0.00%
0/26
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/26
|
0.00%
0/26
|
3.8%
1/26 • Number of events 1
|
Other adverse events
| Measure |
Training Period
n=26 participants at risk
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.
|
Self or Partner Administration
n=26 participants at risk
The self or partner administration block (after training period) included three unsupervised injections every 28th day at the subject's home.
|
HCP Administration
n=26 participants at risk
A healthcare administration block included three HCP provided injections according to clinical routine every 28th day at the healthcare provider facility.
|
|---|---|---|---|
|
General disorders
Disease progression
|
0.00%
0/26
|
3.8%
1/26 • Number of events 2
|
7.7%
2/26 • Number of events 2
|
|
Vascular disorders
Flushing
|
0.00%
0/26
|
3.8%
1/26 • Number of events 2
|
7.7%
2/26 • Number of events 2
|
|
Nervous system disorders
Headache
|
11.5%
3/26 • Number of events 4
|
3.8%
1/26 • Number of events 1
|
0.00%
0/26
|
|
General disorders
Injection site pain
|
15.4%
4/26 • Number of events 4
|
3.8%
1/26 • Number of events 3
|
11.5%
3/26 • Number of events 6
|
|
Gastrointestinal disorders
Nausea
|
11.5%
3/26 • Number of events 4
|
3.8%
1/26 • Number of events 1
|
0.00%
0/26
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60