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Pathogenesis of functional dyspepsia is poorly understood. Gastrointestinal motor abnormalities, Helicobacter pylori infection, impaired gastric accommodation to a meal, hypersensitivity of the afferent nerves of the gut, psychological disturbances and central nervous system dysfunction have been proposed.
Pharmacological treatments for patients with functional dyspepsia remain unsatisfactory. Only small benefits relative to placebo have been found with histamine H2 receptor antagonists, proton pump inhibitor and Helicobacter pylori eradication.
Itopride is a dopamine antagonist with acetylcholinesterase inhibitory actions. This agent is currently indicated for patients with various upper GI symptoms.
This study is aimed to evaluate the effect of Itopride on gastric emptying(by 13-C Octanoic acid breath Test), accommodation (by Gastric Scintigraphy SPECT and slow nutrient drinking test)and symptoms in FD patients
phase3 clinical trial
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1.Itopride Group | Experimental | The itopride group will receive itopride 150mg per day(50mg TDS)for four weeks |
|
| 2.Control placebo group | Placebo Comparator | The control group will receive placebo tablets for four weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Itopride, | Drug | Itopride,50 mg capsules,thrice a day,for Four weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess the effect of Itopride on Gastric Emptying,accommodation and capacity of tolerating a nutrient drink in patients with Functional Dyspepsia | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the effect of Itopride on symptom improvement in patient with Functional Dyspepsia | 18 months |
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Inclusion Criteria:
Exclusion Criteria:
Age <18 years
Helicobacter Pylori positive on gastric biopsy and / or UBT.
Taking other medications that alter gastric motility like macrolide
Pregnant or breast-feeding females.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shahab Abid, MD | Contact | +92 21 4864656 | 4656 | shahab.abid@aku.edu |
| Wasim Jafri, MD | Contact | +92 21 4864659 | 4659 | wasim.jafri@aku.edu |
| Name | Affiliation | Role |
|---|---|---|
| Shahab Abid, MD | Aga Khan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aga Khan University | Recruiting | Karachi | Sindh | 74800 | Pakistan |
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| ID | Term |
|---|---|
| C102254 | itopride |
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| Placebo | Drug | placebo capsules,thrice a day for four weeks |
|