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

Study Overview
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Brief Summary
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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

Official Title
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A Randomized, Placebo Controlled Study on the Efficacy of Itopride HCI on Irritable Bowel in Patients of Irritable Bowel Syndrome With Constipation (IBS-C)

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Drug: Itopride HCI 50 mg
* Drug: Itopride HCI 100 mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patient fulfilling the Rome III criteria for IBS-C Signed informed consent at screening visit Exclusion Criteria: Patients having significant diarrhea at least 25% of the time during the past 3 months Patients having alarm symptoms or signs Chronic diarrhea 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Itopride 50 mg<br> | Drug: Itopride HCI 50 mg<br>* Variable dosing<br>* Other names: Ganaton;|
| Active Comparator: Itopride 100 mg<br> | Drug: Itopride HCI 100 mg<br>* Variable dosing<br>* Other names: Ganaton;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Variable dosing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients will be asked a simple but well validated question If there is a satisfactory relief of the symptoms |  | 2 weeks and 4 weeks after the start of the treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjects will be assessed based on Irritable Bowel Syndrome Severity Score (IBSSS). |  | 2 weeks and 4 weeks after the start of the treatment | 
| Safety based on the laboratory tests before and at the end of the treatment. |  | 4 weeks during the treatment period and 4 weeks following post- therapy period. |