E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
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 |
The main efficacy variable will be; Responder Rates for adequate relief of abdominal pain/discomfortesponder Rates for adequate relief of IBS symptoms |
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E.2.2 | Secondary objectives of the trial |
Global Improvement based on a 7 -point Likert scale performed on amonthly basis. Composite score Individual scores for the primary IBS symptoms; Bloating Diarrhoea Constipation An IBS -specific QOL and HADs score |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Be female and between 18 and 65 years of age;
2. Be able to give written informed consent;
3. Be willing to comply with the study requirements;
4. Be post-menopausal or, if of child-bearing potential, agree to use an adequate form of contraception (e.g., surgical sterilization, birth control pills, birth control implants, condoms AND spermicide, abstinence) as approved by the Investigator;
5. Be willing to refrain from taking any dietary supplements or other foods that contain fermented live bacteria during the study;
6. Be willing to refrain from taking any medications or preparations used in the therapy of IBS (herbal, dietary supplements, homeopathic preparations, etc.) during the study;
7. If using fiber supplements (e.g., Trifyba, Fybogel, Konsyl, Isogel, Regulan, Ispagel, Celevac, Normacol), the dose and regimen have remained stable for at least 30 days and the subject will continue the same dose and regimen throughout the length of the trial.
8. If using anti-depressants, the dose and regimen have remained stable for at least 90 days and the subject will continue the same dose and regimen throughout the length of the trial;
9. If using products that contain nicotine or caffeine, agrees to continue current usage levels throughout the length of the trial;
10. Have not participated in a clinical drug study or used an investigational new drug during the previous 30 days;
11. Be in generally good health as determined by the Investigator, except for IBS symptoms;
12. Have symptoms supportive of IBS: altered stool form, altered stool frequency, abnormal stool passage, passage of mucus, feeling of bloating or abdominal distension; and
13. Satisfy the essential features of the Rome III diagnostic criteria for IBS which are: Recurrent abdominal pain or discomfort For at least 3 days/month in last 3 months associated with two or more of the following: a. Improvement with defecation, b. Onset associated with a change in frequency of stool, c. Onset associated with a change in form [appearance] of stool.
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E.4 | Principal exclusion criteria |
1. Are pregnant or nursing (lactating) females;
2. Have IBS symptoms predominantly related to menstruation;
3. Have alarm symptoms suggestive of an underlying organic disease (weight loss, nocturnal symptoms, blood in stools, family history of colorectal cancer, relevant abnormalities on physical examinations, short duration of symptoms, progressive deterioration of symptoms, abnormal laboratory test, positive stool cultures in subjects with diarrhoea-predominant IBS or abnormalities on colonoscopy/sigmoidoscopy or abdominal ultrasound which require further investigation);
4. Have undergone prior gastrointestinal surgery (apart from appendectomy and hernia repair);
5. Subjects over 55 years of age who have not had a sigmoidoscopy/colonoscopy performed in the previous 5 years;
6. Have a significant acute or chronic coexisting illness (cardiovascular, gastrointestinal, immunological, etc.) or condition (excluding IBS) which, in the Investigator’s judgment, contraindicates administration of the study medication or participation in the study;
7. Have evidence of or history of t of malignancy (other than localized basal cell, squamous cell skin cancer or cancer in situ that has been resected) within the previous five years;
8. Use of anti-psychotics in the prior three months;
9. Use of systemic steroids within the prior month;
10. Have a condition, or are taking a medication, that the investigator believes would interfere with the objectives of the study, pose a safety risk or confound the interpretation of the study results;
11. Have evidence of immunodeficiency;
12. Major psychiatric disorder (DSM-III-R or DSM-IV), including major depression, psychoses, alcohol or substance abuse within the past 2 years;
13. Subject is participating in a psychological IBS treatment approach that was initiated within the past 6 months (behavioural therapy, hypnosis, etc);
14. Individuals who, in the opinion of the Investigator, are considered to be poor clinical attendees or unlikely for any reason to be able to comply with the trial;
15. Subjects who were previously screened for participation in this study and failed to meet entry criteria.
16. Subjects who have had a previous cholescystectomy.
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary Efficacy Variables The primary efficacy variables will be:
• Responder Rates for adequate relief of abdominal pain/discomfort. • Responder Rates for adequate relief of IBS symptoms.
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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 | No |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
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 | Yes |
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 | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |