E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Irritable Bowel Syndrome (IBS) |
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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 primary objective of this study is to evaluate the effect of AZD7371 20 mg bid, AZD7371 5 mg bid and placebo on rectal sensitivity during rectal distension by assessment of discomfort by using a newly developed Sensitivity Index (SI). |
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E.2.2 | Secondary objectives of the trial |
to evaluate the effect of AZD7371 20 mg bid, AZD7371 5 mg bid and placebo on rectal sensitivity during rectal distension by assessment of discomfort and pain using a newly developed Electronic Analogue Scale (EAS). · to evaluate the effect of AZD7371 20 mg bid, AZD7371 5 mg bid and placebo on volumetric measures (maximum volume, compliance, accommodation), on autonomic response (heart rate and blood pressure), and on visceromotor response (EMG and ANS measures) during rectal distension. · to evaluate the effect of AZD7371 20 mg bid, AZD7371 5 mg bid and placebo by assessment of the proportion of patients with complete relief of overall IBS symptoms after one week of treatment · to evaluate the effect of AZD7371 20 mg bid, AZD7371 5 mg bid and placebo by assessment of the proportion of patients with adequate relief of overall IBS symptoms after one week of treatment (etc.) |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Provision of written informed consent 2. Male or female patients aged 20-65 years 3. IBS patients defined by the Rome II criteria 4. Females of childbearing potential must use one of the following acceptable birth control methods: surgical sterilization, intrauterine device or oral contraceptives for at least 14 days prior to the first dose and throughout the study 5. Body Mass Index (BMI) of 19-30. Weight 55-90 kg |
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E.4 | Principal exclusion criteria |
1. Other gastrointestinal (GI) disease of importance 2. Clinically significant haematological, renal, hepatic, cardiovascular, neurological, mental or other serious disease 3. History of GI surgery except minor surgery (e.g. appendectomy, cholecystectomy or gynaecological surgery). 4. Any clinically significant abnormal physical findings relevant for the safety of the patient as judged by the investigator, including ECG or any clinically significant abnormal laboratory value 5. Positive drug screen indicating drug abuse or history of drug addiction or alcohol abuse 6. Pregnancy or lactation 7. Medications known to affect the gastrointestinal tract. If the patient uses any of the medication below or any other medication known to affect the gastrointestinal tract, these should be discontinued at least two weeks prior to visit 2: tricyclic antidepressants selective serotonin reuptake inhibitors gastrointestinal prokinetics (e.g. cisapride, metroclopramide) laxatives antidiarrhoeals antiemetics opioids anticholinergic/antispasmodic drugs analgesics mineral herb medication OTC CYP3A4 inhibitors, including, but not limited to antifungals, HIV antivirals macrolides and mifepristone CYP3A4 inducers, including but not limited to phenobarbital, phenytoin, carbamazepine and rifampin 8. History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity 9. Administration of any investigational product within eight weeks preceding the first dose of the investigational product 10. Previous randomization in the study 11. Blood donation within 12 weeks preceding the first dose of the investigational product 12. A suspected/manifested infection according to WHO risk categories 2, 3 and 4 (see Protocol Appendix D) 13. Involvement in the planning and conduct of the study 14. Previous participation in more than one study with this compound 15. Inability to understand and complete the questionnaires and diary cards 16. Suspected or confirmed poor compliance. |
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E.5 End points |
E.5.1 | Primary end point(s) |
A positive change on a newly developed Sensitivity Index (SI). |
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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 | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Yes |
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 | Yes |
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 | Information not present in EudraCT |
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 | |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 12 |