Study to Evaluate the Role of Itopride HCI in Patients With Irritable Bowel Syndrome With Predominant Constipation

Launched by ABBOTT · Dec 4, 2009

Keywords

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Gender

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Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female patient fulfilling the Rome III criteria for IBS-C
• • 2. Signed informed consent at screening visit
• Exclusion Criteria:
• • 1. Patients having significant diarrhea at least 25% of the time during the past 3 months
• • 2. Patients having alarm symptoms or signs
• • 3. Chronic diarrhea
• • 4. History of gastrointestinal haemorrhage, mechanical obstruction or perforation
• • 5. Patient with clinically relevant ECG abnormalities (prolonged QT interval)
• • 6. Active psychiatric disorder that would interfere with the study objectives
• • 7. Health conditions (e.g. age related impairment of cognitive functions) that would interfere with the study objectives or might impair the compliance of the patient
• • 8. Severe hepatic, renal, cardiac, metabolic, haematological or malignant diseases (including prolactin dependent tumours) or clinically relevant deviations in laboratory values (AST/ALT greater than twice the upper limit of normal, serum creatinine \* 2 mg/dl \[177 µmol/l\] according to the medical judgement of the investigator
• • 9. Patient with hypokalemia (serum potassium \< 3.5 mmol/l).
• • 10. History of any known hypersensitivity to the ingredients of the investigational drug
• • 11. Pregnancy or lactation
• • 12. Women with childbearing potential who do not apply a medically accepted method of contraception.