Diarrhea
Conditions
Keywords
symptomatic treatment of patients with refractory diarrhea
Brief summary
The purpose of this study, is to assess the effect of lanreotide Autogel 120mg on stool frequency in subjects with refractory diarrhea at day 28 (mean of last 7 days) compared to baseline.
Interventions
Autogel 120mg
Sponsors
Ipsen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male/female with refractory diarrhea for at least 1 month, after normal extended work-up to exclude causes of diarrhea, not or not enough responding to standard anti-diuretics as evaluated by the investigator * Patient mentally fit for completing a diary
Exclusion criteria
* Has already received a treatment with somatostatin analogues for the treatment of refractory diarrhea * Had a weight of stool \< 600g in a 72hrs stool collection * Has received a treatment with laxatives within the last week before study entry * Suffers from IBS with alternating bowel habits and predominant constipation, suffers from infectious and/or inflammatory gastro-enteritis (colitis ulcerosa, crohn's disease and macroscopic colitis)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Patients Having Minimum Reduction of 50% or Normalization (≤3 Stools/24hours) in the Mean Number of Stools (Mean of Last 7 Days) | Day 28 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in QOL-Quality of Life {Assess Using Short Form (SF-36) and Irritable Bowel Syndrome (IBS)-QOL} Compared to Baseline | Baseline (Day 1), Day 21, Day 28, Day 49 and Day 56 | 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 |
| Change in Median Score of Stool Consistency (Bristol Stool Form Scale) Compared to Baseline | Baseline (day 1), day 28 and day 56 | 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 |
| Percent Change in Mean Number of Stools Compared to Baseline | Baseline (Day 1), Day 28 and Day 56 | — |
| Change From Baseline in Relative Frequency of Normalization (≤3 Stools) in Subjects | Baseline (Day 1), Day 28 and Day 56 | Normalization of stool frequency in subjects with refractory diarrhoea at Day 28 and Day 56 (mean of last 7 days) compared to Baseline. |
| Percentage of Patients Having Minimum Reduction of At Least 50% or Normalization of the Mean Number of Stools | Day 56 | — |
Countries
Belgium
Participant flow
Recruitment details
This was a multicentered study performed at 18 investigational sites in Belgium of which 11 recruited patients.
Participants by arm
| Arm | Count |
|---|---|
| Lanreotide Autogel 120 mg Lanreotide Autogel 120 mg one subcutaneous injection on Day 1 and Day 28. | 36 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Pre-assignment | Consent withdrawal | 1 |
| Pre-assignment | Inclusion/exclusion | 5 |
| Treatment | Adverse Event | 2 |
| Treatment | Death | 1 |
| Treatment | Lack of Efficacy | 5 |
| Treatment | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Lanreotide Autogel 120 mg |
|---|---|
| Age, Continuous | 55.2 Years STANDARD_DEVIATION 16.4 |
| Age, Customized >=30 to <65 years | 22 participants |
| Age, Customized <30 years | 2 participants |
| Age, Customized >=65 years | 12 participants |
| Mean Number of Stools | 5.5 Number of Stools STANDARD_DEVIATION 2.3 |
| Quality Of Life (QOL) - Scales IBS QOL: Total Score | 47.4 units on a scale STANDARD_DEVIATION 18.5 |
| Quality Of Life (QOL) - Scales SF36 QOL: Bodily Pain | 48.7 units on a scale STANDARD_DEVIATION 30.4 |
| Quality Of Life (QOL) - Scales SF36 QOL: General Health | 43.9 units on a scale STANDARD_DEVIATION 22.8 |
| Quality Of Life (QOL) - Scales SF36 QOL: Mental Health | 47.6 units on a scale STANDARD_DEVIATION 23.1 |
| Quality Of Life (QOL) - Scales SF36 QOL: Physical Functioning | 60.5 units on a scale STANDARD_DEVIATION 29.1 |
| Quality Of Life (QOL) - Scales SF36 QOL: Role Emotional | 52.8 units on a scale STANDARD_DEVIATION 38.7 |
| Quality Of Life (QOL) - Scales SF36 QOL: Role Physical | 39.6 units on a scale STANDARD_DEVIATION 30.9 |
| Quality Of Life (QOL) - Scales SF36 QOL: Social Functioning | 41.1 units on a scale STANDARD_DEVIATION 31.2 |
| Quality Of Life (QOL) - Scales SF36 QOL: Vitality | 38.8 units on a scale STANDARD_DEVIATION 24.1 |
| Race [Caucasian / White] | 36 Participants |
| Score of Stool Consistency (Bristol Stool Form Scale) | 6.0 units on a scale |
| Sex: Female, Male Female | 24 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 30 / 36 |
| serious Total, serious adverse events | 5 / 36 |
Outcome results
Primary
Percentage of Patients Having Minimum Reduction of 50% or Normalization (≤3 Stools/24hours) in the Mean Number of Stools (Mean of Last 7 Days)
Time frame: Day 28
Population: Intention to Treat (ITT) Population \[All treated subjects with at least 3 Days of available primary efficacy variable data for both Baseline and post Baseline periods\]
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
Secondary
Change From Baseline in Relative Frequency of Normalization (≤3 Stools) in Subjects
Normalization of stool frequency in subjects with refractory diarrhoea at Day 28 and Day 56 (mean of last 7 days) compared to Baseline.
Time frame: Baseline (Day 1), Day 28 and Day 56
Population: ITT Population; Missing number of subjects = 1
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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
Change in Median Score of Stool Consistency (Bristol Stool Form Scale) Compared to Baseline
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
Time frame: Baseline (day 1), day 28 and day 56
Population: ITT Population; Missing number of subjects = 1
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
Secondary
Change in QOL-Quality of Life {Assess Using Short Form (SF-36) and Irritable Bowel Syndrome (IBS)-QOL} Compared to Baseline
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
Time frame: Baseline (Day 1), Day 21, Day 28, Day 49 and Day 56
Population: ITT Population, Analysis based on number (n) of patients with a valid value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
Secondary
Percentage of Patients Having Minimum Reduction of At Least 50% or Normalization of the Mean Number of Stools
Time frame: Day 56
Population: ITT Population; Missing number of subjects: 1
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lanreotide Autogel 120 mg | 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 |
| Lanreotide Autogel 120 mg | 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 |
Secondary
Percent Change in Mean Number of Stools Compared to Baseline
Time frame: Baseline (Day 1), Day 28 and Day 56
Population: ITT Population; Missing number of subjects = 1
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lanreotide Autogel 120 mg | Percent Change in Mean Number of Stools Compared to Baseline | Change from Baseline to Day 28 | -25.9 Percent change | Standard Deviation 36.7 |
| Lanreotide Autogel 120 mg | Percent Change in Mean Number of Stools Compared to Baseline | Change from Baseline to Day 56 | -30.7 Percent change | Standard Deviation 38 |