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

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2004-000383-27-SE
• Date of registration: 15/06/2004
• Prospective Registration: Yes
• Primary sponsor: AstraZeneca AB
• Public title: 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
• Scientific title: 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
• Date of first enrolment: 28/07/2004
• Target sample size: 48
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-000383-27
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: yes Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Sweden

Key inclusion & exclusion criteria

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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Irritable Bowel Syndrome (IBS)

Intervention(s)

Product Name: AZD7371 ER Tablets 5 mg
Product Code: AZD7371
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: Robalzotan
Current Sponsor code: AZD7371
Other descriptive name: NAD-299
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Prolonged-release tablet
Route of administration of the placebo: Oral use

Product Name: AZD7371 ER Tablets 20 mg
Product Code: AZD7371
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: Robalzotan
Current Sponsor code: AZD7371
Other descriptive name: NAD-299
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Prolonged-release tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Secondary Objective: 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.)

Main Objective: 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).

Primary end point(s): A positive change on a newly developed Sensitivity Index (SI).

Secondary ID(s)

D1803C00002