Study to Evaluate the Role of Itopride HCI in Patients With Irritable Bowel Syndrome With Predominant Constipation
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Patients suffering from Irritable Bowel Syndrome with predominant constipation will be provided with the study medication. The study medication will be evaluated for its efficacy in relieving the symptoms
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Ages Eligible for Study:
18 Years to 50 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Male or female patient fulfilling the Rome III criteria for IBS-C
Signed informed consent at screening visit
Patients having significant diarrhea at least 25% of the time during the past 3 months
Patients having alarm symptoms or signs
History of gastrointestinal haemorrhage, mechanical obstruction or perforation
Patient with clinically relevant ECG abnormalities (prolonged QT interval)
Active psychiatric disorder that would interfere with the study objectives
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
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
Patient with hypokalemia (serum potassium < 3.5 mmol/l).
History of any known hypersensitivity to the ingredients of the investigational drug
Pregnancy or lactation
Women with childbearing potential who do not apply a medically accepted method of contraception.