Trial Outcomes & Findings for Lanreotide Autogel in the Symptomatic Treatment of Refractory Diarrhea (NCT NCT00891371)
NCT ID: NCT00891371
Last Updated: 2019-01-15
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
42 participants
Primary outcome timeframe
Day 28
Results posted on
2019-01-15
Participant Flow
This was a multicentered study performed at 18 investigational sites in Belgium of which 11 recruited patients.
Participant milestones
| Measure |
Lanreotide Autogel 120 mg
Lanreotide Autogel 120 mg one subcutaneous injection on Day 1 and Day 28.
|
|---|---|
|
Pre-assignment
STARTED
|
42
|
|
Pre-assignment
COMPLETED
|
36
|
|
Pre-assignment
NOT COMPLETED
|
6
|
|
Treatment
STARTED
|
36
|
|
Treatment
COMPLETED
|
27
|
|
Treatment
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
Lanreotide Autogel 120 mg
Lanreotide Autogel 120 mg one subcutaneous injection on Day 1 and Day 28.
|
|---|---|
|
Pre-assignment
Inclusion/exclusion
|
5
|
|
Pre-assignment
Consent withdrawal
|
1
|
|
Treatment
Lack of Efficacy
|
5
|
|
Treatment
Adverse Event
|
2
|
|
Treatment
Death
|
1
|
|
Treatment
Lost to Follow-up
|
1
|
Baseline Characteristics
Lanreotide Autogel in the Symptomatic Treatment of Refractory Diarrhea
Baseline characteristics by cohort
| Measure |
Lanreotide Autogel 120 mg
n=36 Participants
Lanreotide Autogel 120 mg one subcutaneous injection on Day 1 and Day 28.
|
|---|---|
|
Age, Continuous
|
55.2 Years
STANDARD_DEVIATION 16.4 • n=99 Participants
|
|
Age, Customized
<30 years
|
2 participants
n=99 Participants
|
|
Age, Customized
>=30 to <65 years
|
22 participants
n=99 Participants
|
|
Age, Customized
>=65 years
|
12 participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
|
Race [Caucasian / White]
|
36 Participants
n=99 Participants
|
|
Quality Of Life (QOL) - Scales
SF36 QOL: Physical Functioning
|
60.5 units on a scale
STANDARD_DEVIATION 29.1 • n=99 Participants
|
|
Quality Of Life (QOL) - Scales
SF36 QOL: Role Physical
|
39.6 units on a scale
STANDARD_DEVIATION 30.9 • n=99 Participants
|
|
Quality Of Life (QOL) - Scales
SF36 QOL: Role Emotional
|
52.8 units on a scale
STANDARD_DEVIATION 38.7 • n=99 Participants
|
|
Quality Of Life (QOL) - Scales
SF36 QOL: Vitality
|
38.8 units on a scale
STANDARD_DEVIATION 24.1 • n=99 Participants
|
|
Quality Of Life (QOL) - Scales
SF36 QOL: Mental Health
|
47.6 units on a scale
STANDARD_DEVIATION 23.1 • n=99 Participants
|
|
Quality Of Life (QOL) - Scales
SF36 QOL: Social Functioning
|
41.1 units on a scale
STANDARD_DEVIATION 31.2 • n=99 Participants
|
|
Quality Of Life (QOL) - Scales
SF36 QOL: Bodily Pain
|
48.7 units on a scale
STANDARD_DEVIATION 30.4 • n=99 Participants
|
|
Quality Of Life (QOL) - Scales
SF36 QOL: General Health
|
43.9 units on a scale
STANDARD_DEVIATION 22.8 • n=99 Participants
|
|
Quality Of Life (QOL) - Scales
IBS QOL: Total Score
|
47.4 units on a scale
STANDARD_DEVIATION 18.5 • n=99 Participants
|
|
Score of Stool Consistency (Bristol Stool Form Scale)
|
6.0 units on a scale
n=99 Participants
|
|
Mean Number of Stools
|
5.5 Number of Stools
STANDARD_DEVIATION 2.3 • n=99 Participants
|
PRIMARY outcome
Timeframe: Day 28Population: Intention to Treat (ITT) Population \[All treated subjects with at least 3 Days of available primary efficacy variable data for both Baseline and post Baseline periods\]
Outcome measures
| Measure |
Lanreotide Autogel 120 mg
n=36 Participants
Lanreotide Autogel 120 mg one subcutaneous injection on Day 1 and Day 28
|
|---|---|
|
Percentage of Patients Having Minimum Reduction of 50% or Normalization (≤3 Stools/24hours) in the Mean Number of Stools (Mean of Last 7 Days)
Reduction of at least 50% or normalization - No
|
55.6 Percentage of patients
|
|
Percentage of Patients Having Minimum Reduction of 50% or Normalization (≤3 Stools/24hours) in the Mean Number of Stools (Mean of Last 7 Days)
Reduction of at least 50% or normalization - Yes
|
44.4 Percentage of patients
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 21, Day 28, Day 49 and Day 56Population: ITT Population, Analysis based on number (n) of patients with a valid value.
SF36 QOL includes 1 multi-item scale measuring each of 8 health concepts. These scores are summed to produce raw scale scores for each health concept which are transformed to a 0-100 scale. The lower the score the more disability. The higher the score the less disability. There is in addition a single-item measure of Health Transition IBS-QOL is a self-report QOL measure specific to IBS that can be used to assess impact of IBS and its treatment. This consists of 34 items,each with a 5 point response scale.Individual responses to 34 items are summed and averaged for a total score and transformed to a 0-100 scale with higher scores indicating better IBS specific QOL
Outcome measures
| Measure |
Lanreotide Autogel 120 mg
n=36 Participants
Lanreotide Autogel 120 mg one subcutaneous injection on Day 1 and Day 28
|
|---|---|
|
Change in QOL-Quality of Life {Assess Using Short Form (SF-36) and Irritable Bowel Syndrome (IBS)-QOL} Compared to Baseline
SF36 QOL: General Health (D28), n=33
|
2.8 units on a scale
Standard Deviation 16.8
|
|
Change in QOL-Quality of Life {Assess Using Short Form (SF-36) and Irritable Bowel Syndrome (IBS)-QOL} Compared to Baseline
SF36 QOL: Physical Functioning (D21), n=33
|
-1.3 units on a scale
Standard Deviation 20.5
|
|
Change in QOL-Quality of Life {Assess Using Short Form (SF-36) and Irritable Bowel Syndrome (IBS)-QOL} Compared to Baseline
SF36 QOL: Physical Functioning (D49), n=26
|
2.9 units on a scale
Standard Deviation 18.9
|
|
Change in QOL-Quality of Life {Assess Using Short Form (SF-36) and Irritable Bowel Syndrome (IBS)-QOL} Compared to Baseline
SF36 QOL: Role Physical (D49), n=26
|
6.3 units on a scale
Standard Deviation 28.3
|
|
Change in QOL-Quality of Life {Assess Using Short Form (SF-36) and Irritable Bowel Syndrome (IBS)-QOL} Compared to Baseline
SF36 QOL: Role Emotional (D21), n=33
|
-0.3 units on a scale
Standard Deviation 34.8
|
|
Change in QOL-Quality of Life {Assess Using Short Form (SF-36) and Irritable Bowel Syndrome (IBS)-QOL} Compared to Baseline
SF36 QOL: Role Emotional (D28), n=34
|
3.4 units on a scale
Standard Deviation 40.7
|
|
Change in QOL-Quality of Life {Assess Using Short Form (SF-36) and Irritable Bowel Syndrome (IBS)-QOL} Compared to Baseline
SF36 QOL: Role Emotional (D49), n=25
|
7.0 units on a scale
Standard Deviation 35.2
|
|
Change in QOL-Quality of Life {Assess Using Short Form (SF-36) and Irritable Bowel Syndrome (IBS)-QOL} Compared to Baseline
SF36 QOL: Role Emotional (D56), n=35
|
5.0 units on a scale
Standard Deviation 39.6
|
|
Change in QOL-Quality of Life {Assess Using Short Form (SF-36) and Irritable Bowel Syndrome (IBS)-QOL} Compared to Baseline
SF36 QOL: Vitality (D49), n=24
|
2.1 units on a scale
Standard Deviation 24.6
|
|
Change in QOL-Quality of Life {Assess Using Short Form (SF-36) and Irritable Bowel Syndrome (IBS)-QOL} Compared to Baseline
SF36 QOL: General Health (D49), n=26
|
4.1 units on a scale
Standard Deviation 19.1
|
|
Change in QOL-Quality of Life {Assess Using Short Form (SF-36) and Irritable Bowel Syndrome (IBS)-QOL} Compared to Baseline
IBS QOL: Total Score (D56), n=29
|
16.3 units on a scale
Standard Deviation 22.5
|
|
Change in QOL-Quality of Life {Assess Using Short Form (SF-36) and Irritable Bowel Syndrome (IBS)-QOL} Compared to Baseline
SF36 QOL: Role Physical (D56), n=35
|
11.8 units on a scale
Standard Deviation 23.5
|
|
Change in QOL-Quality of Life {Assess Using Short Form (SF-36) and Irritable Bowel Syndrome (IBS)-QOL} Compared to Baseline
SF36 QOL: Vitality (D21), n=32
|
3.1 units on a scale
Standard Deviation 22.1
|
|
Change in QOL-Quality of Life {Assess Using Short Form (SF-36) and Irritable Bowel Syndrome (IBS)-QOL} Compared to Baseline
SF36 QOL: Physical Functioning (D28), n=34
|
2.4 units on a scale
Standard Deviation 19.6
|
|
Change in QOL-Quality of Life {Assess Using Short Form (SF-36) and Irritable Bowel Syndrome (IBS)-QOL} Compared to Baseline
SF36 QOL: Physical Functioning (D56), n=35
|
1.1 units on a scale
Standard Deviation 23.3
|
|
Change in QOL-Quality of Life {Assess Using Short Form (SF-36) and Irritable Bowel Syndrome (IBS)-QOL} Compared to Baseline
SF36 QOL: Role Physical (D21), n=33
|
4.5 units on a scale
Standard Deviation 19.6
|
|
Change in QOL-Quality of Life {Assess Using Short Form (SF-36) and Irritable Bowel Syndrome (IBS)-QOL} Compared to Baseline
SF36 QOL: Role Physical (D28), n=34
|
12.9 units on a scale
Standard Deviation 21.8
|
|
Change in QOL-Quality of Life {Assess Using Short Form (SF-36) and Irritable Bowel Syndrome (IBS)-QOL} Compared to Baseline
SF36 QOL: Vitality (D28), n=33
|
5.9 units on a scale
Standard Deviation 22.2
|
|
Change in QOL-Quality of Life {Assess Using Short Form (SF-36) and Irritable Bowel Syndrome (IBS)-QOL} Compared to Baseline
SF36 QOL: Vitality (D56), n=34
|
7.2 units on a scale
Standard Deviation 23.9
|
|
Change in QOL-Quality of Life {Assess Using Short Form (SF-36) and Irritable Bowel Syndrome (IBS)-QOL} Compared to Baseline
SF36 QOL: Mental Health (D21), n=32
|
5.8 units on a scale
Standard Deviation 27.9
|
|
Change in QOL-Quality of Life {Assess Using Short Form (SF-36) and Irritable Bowel Syndrome (IBS)-QOL} Compared to Baseline
SF36 QOL: Mental Health (D28), n=33
|
8.3 units on a scale
Standard Deviation 28.2
|
|
Change in QOL-Quality of Life {Assess Using Short Form (SF-36) and Irritable Bowel Syndrome (IBS)-QOL} Compared to Baseline
SF36 QOL: Mental Health (D49), n=24
|
8.3 units on a scale
Standard Deviation 27.1
|
|
Change in QOL-Quality of Life {Assess Using Short Form (SF-36) and Irritable Bowel Syndrome (IBS)-QOL} Compared to Baseline
SF36 QOL: Mental Health (D56), n=34
|
10.1 units on a scale
Standard Deviation 27.7
|
|
Change in QOL-Quality of Life {Assess Using Short Form (SF-36) and Irritable Bowel Syndrome (IBS)-QOL} Compared to Baseline
SF36 QOL: Social Functioning (D21), n=31
|
9.3 units on a scale
Standard Deviation 27.8
|
|
Change in QOL-Quality of Life {Assess Using Short Form (SF-36) and Irritable Bowel Syndrome (IBS)-QOL} Compared to Baseline
SF36 QOL: Social Functioning (D28), n=33
|
16.7 units on a scale
Standard Deviation 29.8
|
|
Change in QOL-Quality of Life {Assess Using Short Form (SF-36) and Irritable Bowel Syndrome (IBS)-QOL} Compared to Baseline
SF36 QOL: Social Functioning (D49), n=24
|
19.3 units on a scale
Standard Deviation 34.8
|
|
Change in QOL-Quality of Life {Assess Using Short Form (SF-36) and Irritable Bowel Syndrome (IBS)-QOL} Compared to Baseline
SF36 QOL: Social Functioning (D56), n=33
|
14.0 units on a scale
Standard Deviation 31.5
|
|
Change in QOL-Quality of Life {Assess Using Short Form (SF-36) and Irritable Bowel Syndrome (IBS)-QOL} Compared to Baseline
SF36 QOL: Bodily Pain (D21), n=33
|
-4.6 units on a scale
Standard Deviation 31.5
|
|
Change in QOL-Quality of Life {Assess Using Short Form (SF-36) and Irritable Bowel Syndrome (IBS)-QOL} Compared to Baseline
SF36 QOL: Bodily Pain (D28), n=34
|
8.3 units on a scale
Standard Deviation 28.6
|
|
Change in QOL-Quality of Life {Assess Using Short Form (SF-36) and Irritable Bowel Syndrome (IBS)-QOL} Compared to Baseline
SF36 QOL: Bodily Pain (D49), n=26
|
8.8 units on a scale
Standard Deviation 29.2
|
|
Change in QOL-Quality of Life {Assess Using Short Form (SF-36) and Irritable Bowel Syndrome (IBS)-QOL} Compared to Baseline
SF36 QOL: Bodily Pain (D56), n=35
|
5.3 units on a scale
Standard Deviation 30.7
|
|
Change in QOL-Quality of Life {Assess Using Short Form (SF-36) and Irritable Bowel Syndrome (IBS)-QOL} Compared to Baseline
SF36 QOL: General Health (D21), n=33
|
-2.8 units on a scale
Standard Deviation 16.0
|
|
Change in QOL-Quality of Life {Assess Using Short Form (SF-36) and Irritable Bowel Syndrome (IBS)-QOL} Compared to Baseline
SF36 QOL: General Health (D56), n=34
|
3.7 units on a scale
Standard Deviation 19.9
|
|
Change in QOL-Quality of Life {Assess Using Short Form (SF-36) and Irritable Bowel Syndrome (IBS)-QOL} Compared to Baseline
IBS QOL: Total Score (D21), n=27
|
9.9 units on a scale
Standard Deviation 21.5
|
|
Change in QOL-Quality of Life {Assess Using Short Form (SF-36) and Irritable Bowel Syndrome (IBS)-QOL} Compared to Baseline
IBS QOL: Total Score (D28), n=26
|
13.9 units on a scale
Standard Deviation 22.0
|
|
Change in QOL-Quality of Life {Assess Using Short Form (SF-36) and Irritable Bowel Syndrome (IBS)-QOL} Compared to Baseline
IBS QOL: Total Score (D49), n=22
|
16.8 units on a scale
Standard Deviation 22.5
|
SECONDARY outcome
Timeframe: Baseline (day 1), day 28 and day 56Population: ITT Population; Missing number of subjects = 1
Each patient scored his/her stool on the Bristol Stool Form Scale: Type 1 - Separate hard lumps, like nuts (hard to pass); Type 2 - Sausage-shaped but lumpy; Type 3 - Like a sausage but with cracks on its surface; Type 4 - Like a sausage or snake, smooth and soft; Type 5 - Soft blobs with clear-cut edges (passed easily); Type 6 - Fluffy pieces with ragged edges, a mushy stool; Type 7 - Water no solid pieces, Entirely liquid
Outcome measures
| Measure |
Lanreotide Autogel 120 mg
n=35 Participants
Lanreotide Autogel 120 mg one subcutaneous injection on Day 1 and Day 28
|
|---|---|
|
Change in Median Score of Stool Consistency (Bristol Stool Form Scale) Compared to Baseline
Change from Baseline to Day 28
|
0.0 units on a scale
Interval -3.0 to 1.0
|
|
Change in Median Score of Stool Consistency (Bristol Stool Form Scale) Compared to Baseline
Change from Baseline to Day 56
|
-0.5 units on a scale
Interval -4.0 to 1.0
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 28 and Day 56Population: ITT Population; Missing number of subjects = 1
Outcome measures
| Measure |
Lanreotide Autogel 120 mg
n=35 Participants
Lanreotide Autogel 120 mg one subcutaneous injection on Day 1 and Day 28
|
|---|---|
|
Percent Change in Mean Number of Stools Compared to Baseline
Change from Baseline to Day 28
|
-25.9 Percent change
Standard Deviation 36.7
|
|
Percent Change in Mean Number of Stools Compared to Baseline
Change from Baseline to Day 56
|
-30.7 Percent change
Standard Deviation 38.0
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 28 and Day 56Population: ITT Population; Missing number of subjects = 1
Normalization of stool frequency in subjects with refractory diarrhoea at Day 28 and Day 56 (mean of last 7 days) compared to Baseline.
Outcome measures
| Measure |
Lanreotide Autogel 120 mg
n=35 Participants
Lanreotide Autogel 120 mg one subcutaneous injection on Day 1 and Day 28
|
|---|---|
|
Change From Baseline in Relative Frequency of Normalization (≤3 Stools) in Subjects
Change from Baseline to Day 28
|
27.5 Percentage of days per Week
Standard Deviation 34.7
|
|
Change From Baseline in Relative Frequency of Normalization (≤3 Stools) in Subjects
Change from Baseline to Day 56
|
33.0 Percentage of days per Week
Standard Deviation 34.3
|
SECONDARY outcome
Timeframe: Day 56Population: ITT Population; Missing number of subjects: 1
Outcome measures
| Measure |
Lanreotide Autogel 120 mg
n=35 Participants
Lanreotide Autogel 120 mg one subcutaneous injection on Day 1 and Day 28
|
|---|---|
|
Percentage of Patients Having Minimum Reduction of At Least 50% or Normalization of the Mean Number of Stools
Reduction of at least 50% or normalization - Yes
|
54.3 Percentage of participants
|
|
Percentage of Patients Having Minimum Reduction of At Least 50% or Normalization of the Mean Number of Stools
Reduction of at least 50% or normalization - No
|
45.7 Percentage of participants
|
Adverse Events
Lanreotide Autogel 120 mg
Serious events: 5 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lanreotide Autogel 120 mg
n=36 participants at risk
Lanreotide Autogel 120 mg one subcutaneous injection on Day 1 and Day 28
|
|---|---|
|
Blood and lymphatic system disorders
Pancytopenia
|
2.8%
1/36 • Number of events 1 • Up to Day 56 (± 2)
Treatment Emergent Adverse Events (TEAE)
|
|
Gastrointestinal disorders
Steatorrhoea
|
2.8%
1/36 • Number of events 1 • Up to Day 56 (± 2)
Treatment Emergent Adverse Events (TEAE)
|
|
Infections and infestations
Bronchopneumonia
|
2.8%
1/36 • Number of events 1 • Up to Day 56 (± 2)
Treatment Emergent Adverse Events (TEAE)
|
|
Infections and infestations
Pneumonia
|
2.8%
1/36 • Number of events 1 • Up to Day 56 (± 2)
Treatment Emergent Adverse Events (TEAE)
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
2.8%
1/36 • Number of events 1 • Up to Day 56 (± 2)
Treatment Emergent Adverse Events (TEAE)
|
|
Nervous system disorders
Syncope
|
2.8%
1/36 • Number of events 1 • Up to Day 56 (± 2)
Treatment Emergent Adverse Events (TEAE)
|
|
Psychiatric disorders
Depression
|
2.8%
1/36 • Number of events 1 • Up to Day 56 (± 2)
Treatment Emergent Adverse Events (TEAE)
|
|
Reproductive system and breast disorders
Vaginal fistula
|
2.8%
1/36 • Number of events 1 • Up to Day 56 (± 2)
Treatment Emergent Adverse Events (TEAE)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.8%
1/36 • Number of events 1 • Up to Day 56 (± 2)
Treatment Emergent Adverse Events (TEAE)
|
Other adverse events
| Measure |
Lanreotide Autogel 120 mg
n=36 participants at risk
Lanreotide Autogel 120 mg one subcutaneous injection on Day 1 and Day 28
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
9/36 • Number of events 10 • Up to Day 56 (± 2)
Treatment Emergent Adverse Events (TEAE)
|
|
Gastrointestinal disorders
Constipation
|
5.6%
2/36 • Number of events 2 • Up to Day 56 (± 2)
Treatment Emergent Adverse Events (TEAE)
|
|
Gastrointestinal disorders
Nausea
|
11.1%
4/36 • Number of events 4 • Up to Day 56 (± 2)
Treatment Emergent Adverse Events (TEAE)
|
|
Gastrointestinal disorders
Steatorrhoea
|
5.6%
2/36 • Number of events 2 • Up to Day 56 (± 2)
Treatment Emergent Adverse Events (TEAE)
|
|
General disorders
Fatigue
|
11.1%
4/36 • Number of events 4 • Up to Day 56 (± 2)
Treatment Emergent Adverse Events (TEAE)
|
|
General disorders
Influenza like illness
|
5.6%
2/36 • Number of events 3 • Up to Day 56 (± 2)
Treatment Emergent Adverse Events (TEAE)
|
|
General disorders
Injection site nodule
|
8.3%
3/36 • Number of events 5 • Up to Day 56 (± 2)
Treatment Emergent Adverse Events (TEAE)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
8.3%
3/36 • Number of events 3 • Up to Day 56 (± 2)
Treatment Emergent Adverse Events (TEAE)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.6%
2/36 • Number of events 2 • Up to Day 56 (± 2)
Treatment Emergent Adverse Events (TEAE)
|
|
Nervous system disorders
Headache
|
11.1%
4/36 • Number of events 5 • Up to Day 56 (± 2)
Treatment Emergent Adverse Events (TEAE)
|
|
Vascular disorders
Hypertension
|
5.6%
2/36 • Number of events 2 • Up to Day 56 (± 2)
Treatment Emergent Adverse Events (TEAE)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place