E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Irritable Bowel Syndrome (IBS) |
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E.1.1.1 | Medical condition in easily understood language |
Irritable Bowel Syndrome (IBS) |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nutritional and Metabolic Diseases [C18] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10021192 |
E.1.2 | Term | IBS |
E.1.2 | System Organ Class | 10017947 - Gastrointestinal disorders |
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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 |
Primary Efficacy Endpoint The proportions of subjects who felt adequate relief of IBS symptoms for at least 2 of the 4 weeks of treatment will be served as the primary efficacy endpoint of the study. Adequate relief of IBS symptoms is defined as a response of "YES" to the following weekly (every 7 days) subject global relief question: "In regards to your IBS symptoms, compared to the way you felt before you started to take the study medication, have you, in the past 7 days, had adequate relief of your IBS symptoms? [YES/NO]. Achieving adequate relief is another way of saying that in comparison with your typical experience of the disease before you have started taking the study medication, you feel that the symptoms of IBS have satisfactorily improved during the past 7 days.
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Primary Efficacy Endpoint The proportions of subjects who felt adequate relief of IBS symptoms for at least 2 of the 4 weeks of treatment will be served as the primary efficacy endpoint of the study. Adequate relief of IBS symptoms is defined as a response of "YES" to the following weekly (every 7 days) subject global relief question: "In regards to your IBS symptoms, compared to the way you felt before you started to take the study medication, have you, in the past 7 days, had adequate relief of your IBS symptoms? [YES/NO]. Achieving adequate relief is another way of saying that in comparison with your typical experience of the disease before you have started taking the study medication, you feel that the symptoms of IBS have satisfactorily improved during the past 7 days.
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E.2.2 | Secondary objectives of the trial |
Secondary efficacy Endpoints (a) Change from baseline in IBS symptoms severity as assessed by the IBSSS after 4 weeks of double blind treatment. (b) Change in feeling of relief of individual IBS symptoms after 1,2,3 and 4 weeks of double blind treatment as compared baseline using the IBS symptom visual analogue scale (VAS). (c) Change from baseline in subjects' subjective assessment of quality of life using the IBS-QOL questionnaire after 4 weeks of double blind treatment. (d) Change from baseline in subjects' subjective assessment of quality of sleep using the Pittsburg Sleep Questionnaire Index (PSQI) parameters. (e) The proportions of subjects who felt adequate relief of IBS symptoms in the last 2 weeks of treatment with 20 mg dose as compared to 40 mg dose.
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Secondary efficacy Endpoints (a) Change from baseline in IBS symptoms severity as assessed by the IBSSS after 4 weeks of double blind treatment. (b) Change in feeling of relief of individual IBS symptoms after 1,2,3 and 4 weeks of double blind treatment as compared baseline using the IBS symptom visual analogue scale (VAS). (c) Change from baseline in subjects' subjective assessment of quality of life using the IBS-QOL questionnaire after 4 weeks of double blind treatment. (d) Change from baseline in subjects' subjective assessment of quality of sleep using the Pittsburg Sleep Questionnaire Index (PSQI) parameters. (e) The proportions of subjects who felt adequate relief of IBS symptoms in the last 2 weeks of treatment with 20 mg dose as compared to 40 mg dose.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Subjects age 18-80 years old 2. Male or female Women of childbearing potential must have a negative pregnancy test at the screening visit, on Day 1 of each treatment period, and use a reliable method of contraception during the entire study duration and for at least 3 months after study drug intake. Reliable methods of contraception are: - oral contraception - Double barrier type devices (e.g., male or female condom, diaphragm, contraceptive sponge) only in combination with a spermicide. - Intra-uterine devices in combination with a spermicide. Abstention, rhythm method, and contraception by the partner alone are not acceptable methods of contraception. Women not of childbearing potential are defined as postmenopausal (i.e., amenorrhea for at least 1 year), or surgically or naturally sterile. 3. Subject has IBS confirmed by the Rome III diagnostic criteria:
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E.4 | Principal exclusion criteria |
1. Subject has current evidence of duodenal ulcer, gastric ulcer, diverticulitis, or infectious gastroenteritis. 2. Subject has a history of inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis, celiac disease), GI malignancy, GI obstruction, gastroparesis, carcinoid syndrome, pancreatitis, amyloidosis or ileus 3. Subject is a candidate for GI surgery or has a history of GI surgery except appendectomy and cholecystectomy. 4. Subject has psychiatric disorders which are not controlled (based on the investigator medical judgment); subject with psychosis are excluded regardless of current therapy. 5. Subject has current or recent history (within 12 months of signing on informed consent) of drug or alcohol abuse. 6. Subject is pregnant or lactating 7. Subject has history of human immunodeficiency virus (HIV) or hepatitis (B or C) 8. Subject has any condition or circumstance that could cause noncompliance with treatments or visits 9. Subject has active malignancy within the last 5 years. 10. Subject taking antipsychotic drugs, antispasmodics, antidiarrhaeals (e.g. loperamide, lubiprostone and bismuth subsalicylate), narcotics, prokinetic drugs, drugs indicated for IBS (e.g Alosteron), or warfarin.
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E.5 End points |
E.5.1 | Primary end point(s) |
The proportions of subjects who felt adequate relief of IBS symptoms for at least 2 of the 4 weeks of treatment will be served as the primary efficacy endpoint of the study. Adequate relief of IBS symptoms is defined as a response of "YES" to the following weekly (every 7 days) subject global relief question: "In regards to your IBS symptoms, compared to the way you felt before you started to take the study medication, have you, in the past 7 days, had adequate relief of your IBS symptoms? [YES/NO]. Achieving adequate relief is another way of saying that in comparison with your typical experience of the disease before you have started taking the study medication, you feel that the symptoms of IBS have satisfactorily improved during the past 7 days.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
(a) Change from baseline in IBS symptoms severity as assessed by the IBSSS after 4 weeks of double blind treatment. (b) Change in feeling of relief of individual IBS symptoms after 1,2,3 and 4 weeks of double blind treatment as compared baseline using the IBS symptom visual analogue scale (VAS). (c) Change from baseline in subjects' subjective assessment of quality of life using the IBS-QOL questionnaire after 4 weeks of double blind treatment. (d) Change from baseline in subjects' subjective assessment of quality of sleep using the Pittsburg Sleep Questionnaire Index (PSQI) parameters. (e) The proportions of subjects who felt adequate relief of IBS symptoms in the last 2 weeks of treatment with 20 mg dose as compared to 40 mg dose.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
E.6.5 | Efficacy | No |
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.8.2.4 | Number of treatment arms in the trial | 2 |
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 | No |
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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last visit or patient drop out date |
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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 |