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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-009356-20 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lanreotide (Autogel formulation) Autogel 120mg | Experimental | lanreotide (Autogel formulation) Autogel 120mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lanreotide (Autogel formulation) | Drug | Autogel 120mg |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OLVZ Aalst | Aalst | 9300 | Belgium | |||
| ZNA Antwerpen |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27423779 | Derived | Bisschops R, De Ruyter V, Demolin G, Baert D, Moreels T, Pattyn P, Verhelst H, Lepoutre L, Arts J, Caenepeel P, Ooghe P, Codden T, Maisonobe P, Petrens E, Tack J. Lanreotide Autogel in the Treatment of Idiopathic Refractory Diarrhea: Results of an Exploratory, Controlled, Before and After, Open-label, Multicenter, Prospective Clinical Trial. Clin Ther. 2016 Aug;38(8):1902-1911.e2. doi: 10.1016/j.clinthera.2016.06.012. Epub 2016 Aug 8. |
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This was a multicentered study performed at 18 investigational sites in Belgium of which 11 recruited patients.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lanreotide Autogel 120 mg | Lanreotide Autogel 120 mg one subcutaneous injection on Day 1 and Day 28. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pre-assignment |
|
| |||||||||||||||||||||
| Treatment |
|
The Safety population was defined as all subjects who received at least one injection of the study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Lanreotide Autogel 120 mg | Lanreotide Autogel 120 mg one subcutaneous injection on Day 1 and Day 28. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | 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] | Posted | Number | Percentage of patients | Day 28 |
|
|
Up to Day 56 (± 2)
Treatment Emergent Adverse Events (TEAE)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lanreotide Autogel 120 mg | Lanreotide Autogel 120 mg one subcutaneous injection on Day 1 and Day 28 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 14.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director, Gastroenterology | Ipsen | clinical.trials@ipsen.com | clinical.trials@ipsen.com |
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| ID | Term |
|---|---|
| D003967 | Diarrhea |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C060347 | lanreotide |
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| Baseline (Day 1), Day 21, Day 28, Day 49 and Day 56 |
| 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 | Baseline (day 1), day 28 and day 56 |
| 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 | Normalization of stool frequency in subjects with refractory diarrhoea at Day 28 and Day 56 (mean of last 7 days) compared to Baseline. | Baseline (Day 1), Day 28 and Day 56 |
| Percentage of Patients Having Minimum Reduction of At Least 50% or Normalization of the Mean Number of Stools | Day 56 |
| Antwerp |
| 2060 |
| Belgium |
| AZ Sint Lucas Brugge | Bruges | 8310 | Belgium |
| UZ Antwerpen #2 | Edegem | 2650 | Belgium |
| ZOL | Genk | 3600 | Belgium |
| AZ Maria Middelares | Ghent | 9000 | Belgium |
| UZ Gent | Ghent | 9000 | Belgium |
| UZ Leuven | Leuven | 3000 | Belgium |
| CHC Cliniques Saint Joseph | Liège | 4000 | Belgium |
| CHU A. Vesale | Montigny-le-Tilleul | 6110 | Belgium |
| AZ Sint-Augustinus | Wilrijk | 2610 | Belgium |
|
| Years |
|
| Age, Customized | Number | participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race [Caucasian / White] | Number | Participants |
|
| Quality Of Life (QOL) - Scales | 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. 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 | Mean | Standard Deviation | units on a scale |
|
| Score of Stool Consistency (Bristol Stool Form Scale) | 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 | Median | Full Range | units on a scale |
|
| Mean Number of Stools | Mean | Standard Deviation | Number of Stools |
|
|
| 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 | ITT Population, Analysis based on number (n) of patients with a valid value. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Day 1), Day 21, Day 28, Day 49 and Day 56 |
|
|
|
| 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 | ITT Population; Missing number of subjects = 1 | Posted | Median | Full Range | units on a scale | Baseline (day 1), day 28 and day 56 |
|
|
|
| Secondary | Percent Change in Mean Number of Stools Compared to Baseline | ITT Population; Missing number of subjects = 1 | Posted | Mean | Standard Deviation | Percent change | Baseline (Day 1), Day 28 and Day 56 |
|
|
|
| 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. | ITT Population; Missing number of subjects = 1 | Posted | Mean | Standard Deviation | Percentage of days per Week | Baseline (Day 1), Day 28 and Day 56 |
|
|
|
| Secondary | Percentage of Patients Having Minimum Reduction of At Least 50% or Normalization of the Mean Number of Stools | ITT Population; Missing number of subjects: 1 | Posted | Number | Percentage of participants | Day 56 |
|
|
|
| 5 |
| 36 |
| 30 |
| 36 |
| Steatorrhoea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Bronchopneumonia | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
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| Vaginal fistula | Reproductive system and breast disorders | MedDRA 14.0 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Steatorrhoea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Injection site nodule | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
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| SF36 QOL: Physical Functioning (D56), n=35 |
|
| SF36 QOL: Role Physical (D21), n=33 |
|
| SF36 QOL: Role Physical (D28), n=34 |
|
| SF36 QOL: Role Physical (D49), n=26 |
|
| SF36 QOL: Role Physical (D56), n=35 |
|
| SF36 QOL: Role Emotional (D21), n=33 |
|
| SF36 QOL: Role Emotional (D28), n=34 |
|
| SF36 QOL: Role Emotional (D49), n=25 |
|
| SF36 QOL: Role Emotional (D56), n=35 |
|
| SF36 QOL: Vitality (D21), n=32 |
|
| SF36 QOL: Vitality (D28), n=33 |
|
| SF36 QOL: Vitality (D49), n=24 |
|
| SF36 QOL: Vitality (D56), n=34 |
|
| SF36 QOL: Mental Health (D21), n=32 |
|
| SF36 QOL: Mental Health (D28), n=33 |
|
| SF36 QOL: Mental Health (D49), n=24 |
|
| SF36 QOL: Mental Health (D56), n=34 |
|
| SF36 QOL: Social Functioning (D21), n=31 |
|
| SF36 QOL: Social Functioning (D28), n=33 |
|
| SF36 QOL: Social Functioning (D49), n=24 |
|
| SF36 QOL: Social Functioning (D56), n=33 |
|
| SF36 QOL: Bodily Pain (D21), n=33 |
|
| SF36 QOL: Bodily Pain (D28), n=34 |
|
| SF36 QOL: Bodily Pain (D49), n=26 |
|
| SF36 QOL: Bodily Pain (D56), n=35 |
|
| SF36 QOL: General Health (D21), n=33 |
|
| SF36 QOL: General Health (D28), n=33 |
|
| SF36 QOL: General Health (D49), n=26 |
|
| SF36 QOL: General Health (D56), n=34 |
|
| IBS QOL: Total Score (D21), n=27 |
|
| IBS QOL: Total Score (D28), n=26 |
|
| IBS QOL: Total Score (D49), n=22 |
|
| IBS QOL: Total Score (D56), n=29 |
|