A double-blind randomized placebo controlled crossover study of AZD7371 ER 5 mg bid, 20 mg bid and placebo treatment for one week on visceral perception and symptoms in patients with Irritable Bowel Syndrome

• Conditions: Irritable Bowel Syndrome (IBS)

• Registration Number: EUCTR2004-000383-27-SE
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-06-15
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 48

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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified