E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Diarrhea-predominant Irritable Bowel Syndrome |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10060845 |
E.1.2 | Term | Diarrhea predominant irritable bowel syndrome |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the efficacy of LACTEOL 340mg in subjects suffering from diarrhea-predominant Irritable Bowel Syndrome (IBS-D) using the subject global assessment of relief. |
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E.2.2 | Secondary objectives of the trial |
- To evaluate safety and tolerability of LACTEOL 340mg in this population - To assess treatment compliance |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Men or non-pregnant, non nursing women, 18 years of age or above.Women of childbearing potential will need to use a medically acceptable contraceptive regimen (systemic contraceptive, intrauterine/intravaginal method or barrier-method). 2. Subjects must meet the Rome III Diagnostic Questionnaire for IBS 3. Subjects having an IBS Symptom Severity Scale (IBS-SSS) score ranging between 100 and 400 4. Subjects having an average Bristol Stool Form Scale score exceeding two (>2) but less than seven (<7) 5. Subject is on a stable diet (no drastic lifestyle changes in the quantity and nature of food) for the duration of the study
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E.4 | Principal exclusion criteria |
1. Diagnosis of Inflammatory Bowel Disease (IBD) 2. Chronic use of systemic steroids (on more than 7 consecutive days) in the month prior to screening 3. Presence of Type 1 or Type 2 diabetes mellitus 4. Suffering from a major psychiatric disorder within the past 2 years prior to screening 5. Diagnosis of autoimmune diseases or disorders (ex: Rheumatoid arthritis, Celiac disease, Multiple sclerosis) 6. Had undergone any invasive abdominal surgery, with the exception of hernia repair or appendectomy or cholecystectomy 7. Presence of current or recent ( within 1 month prior to screening) hematemesis, melena or documented gastrointestinal bleeding or iron-deficiency anemia of clinical signifiance 8. Presence of malignant disease of any kind except for successfully treated skin cancer (basal or squamous cell) or any radiation therapy during the previous 5 years prior to screening 9. Use of antibiotics within 30 days prior to screening 10. Use of any experimental drug within 30 days prior to screening 11. Allergy to active substance or any other ingredient in LACTEOL 340mg 12. Congenital galactosemia, glucose, fructose and/or galactose malabsorption syndrome, lactase deficiency or lactose intolerance 13. Diagnosis of exocrine pancreatic insufficiency |
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E.5 End points |
E.5.1 | Primary end point(s) |
Subject global assessment of relief (SGA): subjects will be considered as being responders if they answer "Yes" at least 50% of the time during the 4-week treatment phase. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 10 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 18 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 18 |
E.8.9.2 | In all countries concerned by the trial days | 0 |