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Administrative reasons
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Irritable bowel syndrome is a complex condition with a high unmet medical need for effective and safe treatment options. Lacteol® is a lactobacillus product used for adjunctive and symptomatic treatment of diarrhea. In this study, Lacteol® 340 mg will be evaluated as a potential therapy for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D).
This study will include the following phases: Screening Phase, Run-In Phase, Double-Blind Treatment Phase and Open-Label Treatment Phase.
Screening: Eligibility of subjects will be evaluated following informed consent signature. Screening procedures/evaluations (physical exam, concomitant medications, clinical laboratory tests) and confirmation of eligibility following Rome III Diagnostic questionnaire will be performed.
Run-In: Subjects will enter a 2-week Run-In Phase during which IBS Symptoms and Stool Characteristics will be recorded. At the end of the Run-In Phase, data collected over the last week will be reviewed. Upon confirmation of IBS-D severity status, subjects may be randomized.
Double-Blind Treatment: Subjects will take study medication (either LACTEOL® 340 mg or Placebo) for 28 days. During this time, IBS Symptoms and Stool Characteristics and global assessment of relief will be recorded, and clinical laboratory tests will be performed. HAD score will be assessed at the end of the double blind treatment.
Open-Label Treatment: All study completers will be eligible for a second 28 day Open-Label Treatment in the event that IBS-D symptoms remain or recur within the month following the end of Double-Blind Treatment. Subjects will take the study medication (LACTEOL® 340 mg) for 28 days. During this time, IBS Symptoms and Stool Characteristics and global assessment of relief will be recorded, and clinical laboratory tests will be performed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LACTEOL® 340 mg | Experimental |
| |
| PLACEBO | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LACTEOL® 340 mg | Drug | LACTEOL® 340 mg will be taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Global Assessment of Relief During the Double-Blind Treatment Phase Using the Subject Global Assessment (SGA) | Subjects were considered as responders if they had answered "Yes" to the following question at least 50% of the time during the 4-week treatment phase: "Over the past week, do you consider that you have had satisfactory relief from your IBS symptoms?" | Weekly Assessment (every 7 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Global Assessment of Relief During the Open-Label Treatment Phase Using the Subject Global Assessment (SGA) | Subjects were considered as responders if they had answered "Yes" to the following question at least 50% of the time during the 4-week treatment phase: "Over the past week, do you consider that you have had satisfactory relief from your IBS symptoms?" | Weekly Assessment (every 7 days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ivan T Shaw, PhD | Axcan Pharma Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bordeaux | France | |||||
Inclusion criteria related to symptom severity and stool characteristics assessed during 2nd week of Run-In Phase; ≥ 5 days of symptom data necessary for randomization; Double-Blind Phase completers eligible for a 28-day open-label treatment with LACTEOL® if symptoms not improved or recurring within 1 month after end of blinded treatment.
First subject in: 22 June 2010; last subject out: 12 September 2011; ten (10) sites were recruited to participate in this trial and 7 of these (4 in France and 3 in Germany) enrolled subjects.
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| ID | Title | Description |
|---|---|---|
| FG000 | LACTEOL® 340 mg | LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening. |
| FG001 | PLACEBO | Matched LACTEOL® placebo was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Double-Blind Treatment Phase |
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| Open-Label Treatment Phase |
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Analysis conducted on the Intent-to-Treat population defined as all randomized subjects
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| ID | Title | Description |
|---|---|---|
| BG000 | LACTEOL® 340 mg | LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening. |
| BG001 | PLACEBO |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Global Assessment of Relief During the Double-Blind Treatment Phase Using the Subject Global Assessment (SGA) | Subjects were considered as responders if they had answered "Yes" to the following question at least 50% of the time during the 4-week treatment phase: "Over the past week, do you consider that you have had satisfactory relief from your IBS symptoms?" | Analysis conducted on the Intent-to-Treat population defined as all randomized subjects; observed case (OC) data with no imputation made | Posted | Number | percentage of participants | Weekly Assessment (every 7 days) |
|
From Informed Consent Form signature up to 28 days following the end of double-blind treatment (symptom recurrence observation period) or up to End of Open-Label Treatment Phase Visit (Days 29 to 38) for subjects continuing with open-label treatment
Adverse events collected during study visits as well as via an interactive voice response system (IVRS) while at home; clinical labs performed at baseline and end of each period; only treatment-emergent adverse events are displayed, ie. events that occurred or worsened in intensity on or after the first dose of study medication in each period.
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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 | LACTEOL® 340 mg Double-Blind Period | LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal infection | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
Because of early termination of this trial, the number of subjects analyzed was too small to perform statistical analyses and draw conclusions relative to the efficacy and safety of LACTEOL®.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Winkler MD, VP, Clinical Development and Operations | Aptalis Pharma US, Inc. | (908) 429-4479 | 4175 | rwinkler@aptalispharma.com |
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| ID | Term |
|---|---|
| C100843 | Lacteol |
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| PLACEBO | Drug | Matched LACTEOL® 340 mg Placebo will be taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening. |
|
| Symptom Severity During the Double-Blind Treatment Phase Using the IBS Symptom Severity Scale (IBS-SSS) Total Score | The IBS-SSS has five questions related to four domains: abdominal pain severity and duration, abdominal distension, dissatisfaction with bowel habit and quality of life. The IBS-SSS score ranges from 0 (best outcome) to 500 (worst outcome). | Weekly assessment (every 7 days) |
| Stool Characteristics During the Double-Blind Treatment Phase Using the Bristol Stool Form Scale | The Bristol Stool Form Scale score ranges from 1 to 7 from hard (score of 1) to watery (score of 7). Data are presented as the mean of daily assessments over a week. | Daily assessment |
| Hospital Anxiety and Depression Scale (HADS) Score During the Double-Blind Phase | The HADS has 14 questions related to 2 domains: Anxiety subscale (7 questions) and Depression subscale (7 questions). Each question is graded from 0 (best outcome) to 3 (worst outcome), for a total score ranging from 0 (best outcome) to 42 (worst outcome). | At Screening and End of Double-Blind Treatment Phase |
| Symptom Severity During the Open-Label Treatment Phase Using the IBS Symptom Severity Scale (IBS-SSS) Total Score | The IBS-SSS has five questions related to four domains: abdominal pain severity and duration, abdominal distension, dissatisfaction with bowel habit and quality of life. The IBS-SSS score ranges from 0 (best outcome) to 500 (worst outcome). | Weekly assessment (every 7 days) |
| Stool Characteristics During the Open-Label Treatment Phase Using the BSFS | The Bristol Stool Form Scale (BSFS) score ranges from 1 to 7 from hard (score of 1) to watery (score of 7). Data are presented as the mean of daily assessments over a week. | Daily assessment |
| Use of Rescue Medication During the Double-Blind and Open-Label Treatment Phases of the Study | Number of subjects using rescue medication (bisacodyl or loperamide) during each treatment phase of the study | 8 weeks |
| Colombes |
| France |
| Marseille | France |
| Nice | France |
| Rouen | France |
| Berlin | Germany |
| Hamburg | Germany |
| Mannheim | Germany |
| NOT COMPLETED |
|
Matched LACTEOL® placebo was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| PLACEBO |
Matched LACTEOL® placebo was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening. |
|
|
| Secondary | Global Assessment of Relief During the Open-Label Treatment Phase Using the Subject Global Assessment (SGA) | Subjects were considered as responders if they had answered "Yes" to the following question at least 50% of the time during the 4-week treatment phase: "Over the past week, do you consider that you have had satisfactory relief from your IBS symptoms?" | Analysis conducted on the Intent-to-Treat population defined as all subjects randomized to double-blind treatment and who subsequently entered the Open-Label Treatment Phase; observed case (OC) data with no imputation made; SGA data not available for one patient so that the analysis was performed on 16 rather than 17 patients | Posted | Number | percentage of participants | Weekly Assessment (every 7 days) |
|
|
|
| Secondary | Symptom Severity During the Double-Blind Treatment Phase Using the IBS Symptom Severity Scale (IBS-SSS) Total Score | The IBS-SSS has five questions related to four domains: abdominal pain severity and duration, abdominal distension, dissatisfaction with bowel habit and quality of life. The IBS-SSS score ranges from 0 (best outcome) to 500 (worst outcome). | Analysis conducted on the Intent-to-Treat population defined as all randomized subjects; observed case (OC) data with no imputation made. Number of participants analyzed refers to number of participants at Baseline. | Posted | Mean | Standard Deviation | units on a scale (from 0 to 500) | Weekly assessment (every 7 days) |
|
|
|
| Secondary | Stool Characteristics During the Double-Blind Treatment Phase Using the Bristol Stool Form Scale | The Bristol Stool Form Scale score ranges from 1 to 7 from hard (score of 1) to watery (score of 7). Data are presented as the mean of daily assessments over a week. | Analysis conducted on the Intent-to-Treat population defined as all randomized subjects; observed case (OC) data with no imputation made. Number of participants analyzed refers to number of participants at Baseline. | Posted | Mean | Standard Deviation | units on a scale (from 1 ato 7) | Daily assessment |
|
|
|
| Secondary | Hospital Anxiety and Depression Scale (HADS) Score During the Double-Blind Phase | The HADS has 14 questions related to 2 domains: Anxiety subscale (7 questions) and Depression subscale (7 questions). Each question is graded from 0 (best outcome) to 3 (worst outcome), for a total score ranging from 0 (best outcome) to 42 (worst outcome). | Analysis conducted on the Intent-to-Treat population defined as all randomized subjects; observed case (OC) data with no imputation made | Posted | Mean | Standard Deviation | units on a scale (from 0 to 42) | At Screening and End of Double-Blind Treatment Phase |
|
|
|
| Secondary | Symptom Severity During the Open-Label Treatment Phase Using the IBS Symptom Severity Scale (IBS-SSS) Total Score | The IBS-SSS has five questions related to four domains: abdominal pain severity and duration, abdominal distension, dissatisfaction with bowel habit and quality of life. The IBS-SSS score ranges from 0 (best outcome) to 500 (worst outcome). | Analysis conducted on the Intent-to-Treat population defined as all subjects randomized to double-blind treatment and who subsequently entered the Open-Label Treatment Phase; observed case (OC) data with no imputation made; baseline defined as the last non-missing assessment prior to the first dose of double-blind medication. | Posted | Mean | Standard Deviation | units on a scale (from 0 to 500) | Weekly assessment (every 7 days) |
|
|
|
| Secondary | Stool Characteristics During the Open-Label Treatment Phase Using the BSFS | The Bristol Stool Form Scale (BSFS) score ranges from 1 to 7 from hard (score of 1) to watery (score of 7). Data are presented as the mean of daily assessments over a week. | Analysis conducted on the Intent-to-Treat population defined as all subjects randomized to double-blind treatment and who subsequently entered the Open-Label Treatment Phase ; observed case (OC) data with no imputation made; baseline defined as the last non-missing assessment prior to the first dose of double-blind study medication | Posted | Mean | Standard Deviation | units on a scale (from 1 to 7) | Daily assessment |
|
|
|
| Secondary | Use of Rescue Medication During the Double-Blind and Open-Label Treatment Phases of the Study | Number of subjects using rescue medication (bisacodyl or loperamide) during each treatment phase of the study | Analysis conducted on the Intent-to-Treat population for both treatment phases | Posted | Number | participants | 8 weeks |
|
|
|
| 0 |
| 13 |
| 2 |
| 13 |
| EG001 | PLACEBO Double-Blind Period | Matched LACTEOL® placebo was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening. | 0 | 13 | 2 | 13 |
| EG002 | LACTEOL® 340 mg Open-Label Period | LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening. | 0 | 17 | 2 | 17 |
| Influenza | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
|
Restrictions vary in accordance with each agreement with the individual investigators. Sponsor will allow publication after a multi-center publication has been published or after an agreed period of time if no such multi-center publication is submitted for publication. Sponsor can ask that Sponsor's confidential information be removed from any publication and can defer publication for a period of time to allow for Sponsor to obtain patent or other intellectual property right protection.
| IBS-SSS score at end of Week 2 (Day 14) |
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| IBS-SSS score at end of Week 3 (Day 21) |
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| IBS-SSS score at end of Week 4 (Day 28) |
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| Bristol Stool Form Score during Week 2 |
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| Bristol Stool Form Score during Week 3 |
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| Bristol Stool Form Score during Week 4 |
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| IBS-SSS score at end of Week 3 (Day 21) |
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| IBS-SSS score at end of Week 4 (Day 28) |
|
| Title | Measurements |
|---|---|
|
| BSFS score during Week 3 |
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| BSFS score during Week 4 |
|