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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Itopride 50 mg | Active Comparator |
| |
| Itopride 100 mg | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Itopride HCI 50 mg | Drug | Variable dosing |
|
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 5870 | Karachi | 74800 | Pakistan | |||
| Site Reference ID/Investigator# 21441 |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| Itopride HCI 100 mg | Drug | Variable dosing |
|
|
| Placebo | Drug | Variable dosing |
|
| Karachi |
| Pakistan |
| Site Reference ID/Investigator# 6130 | Lahore | Pakistan |
| Site Reference ID/Investigator# 8535 | Rawalpindi | Pakistan |
| D004066 | Digestive System Diseases |