Effect Of Itopride On Gastric Emptying And Accommodation In Patients With Functional Dyspepsia (EIGEAPFD)
Primary Purpose
Functional Dyspepsia, Gastric Emptying, Gastric Accommodation
Status
Unknown status
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Itopride,
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Functional Dyspepsia focused on measuring Functional Dyspepsia, Itopride, Gastric Emptying, Gastric Accommodation, Dyspeptic Symptoms
Eligibility Criteria
Inclusion Criteria:
- All adult male or non-pregnant female patients who are diagnosed as functional dyspepsia and fulfilling Rome III criteria (1) will be considered
- Patients should be negative for H. pylori on gastric biopsy and Urea Breath Test.
- duodenal biopsy in these patients should be negative for giardiasis or celiac disease or any other established organic pathology
- A normal upper abdominal ultrasound
- Willing to participate and give consent for participation in the study.
Exclusion Criteria:
- Age <18 years
- Helicobacter Pylori positive on gastric biopsy and / or UBT.
Taking other medications that alter gastric motility like macrolide
- anti-emetics and antibiotics .
- Pregnant or breast-feeding females.
Sites / Locations
- Aga Khan UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1.Itopride Group
2.Control placebo group
Arm Description
The itopride group will receive itopride 150mg per day(50mg TDS)for four weeks
The control group will receive placebo tablets for four weeks
Outcomes
Primary Outcome Measures
To assess the effect of Itopride on Gastric Emptying,accommodation and capacity of tolerating a nutrient drink in patients with Functional Dyspepsia
Secondary Outcome Measures
To assess the effect of Itopride on symptom improvement in patient with Functional Dyspepsia
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01226134
Brief Title
Effect Of Itopride On Gastric Emptying And Accommodation In Patients With Functional Dyspepsia
Acronym
EIGEAPFD
Official Title
Effect Of Itopride On Gastric Emptying And Accommodation In Patients With Functional Dyspepsia
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Unknown status
Study Start Date
February 2009 (undefined)
Primary Completion Date
March 2011 (Anticipated)
Study Completion Date
May 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Aga Khan University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
Detailed Description
phase3 clinical trial
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Dyspepsia, Gastric Emptying, Gastric Accommodation
Keywords
Functional Dyspepsia, Itopride, Gastric Emptying, Gastric Accommodation, Dyspeptic Symptoms
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1.Itopride Group
Arm Type
Experimental
Arm Description
The itopride group will receive itopride 150mg per day(50mg TDS)for four weeks
Arm Title
2.Control placebo group
Arm Type
Placebo Comparator
Arm Description
The control group will receive placebo tablets for four weeks
Intervention Type
Drug
Intervention Name(s)
Itopride,
Other Intervention Name(s)
Gananton
Intervention Description
Itopride,50 mg capsules,thrice a day,for Four weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo capsules,thrice a day for four weeks
Primary Outcome Measure Information:
Title
To assess the effect of Itopride on Gastric Emptying,accommodation and capacity of tolerating a nutrient drink in patients with Functional Dyspepsia
Time Frame
18 months
Secondary Outcome Measure Information:
Title
To assess the effect of Itopride on symptom improvement in patient with Functional Dyspepsia
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All adult male or non-pregnant female patients who are diagnosed as functional dyspepsia and fulfilling Rome III criteria (1) will be considered
Patients should be negative for H. pylori on gastric biopsy and Urea Breath Test.
duodenal biopsy in these patients should be negative for giardiasis or celiac disease or any other established organic pathology
A normal upper abdominal ultrasound
Willing to participate and give consent for participation in the study.
Exclusion Criteria:
Age <18 years
Helicobacter Pylori positive on gastric biopsy and / or UBT.
Taking other medications that alter gastric motility like macrolide
anti-emetics and antibiotics .
Pregnant or breast-feeding females.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shahab Abid, MD
Phone
+92 21 4864656
Ext
4656
Email
shahab.abid@aku.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Wasim Jafri, MD
Phone
+92 21 4864659
Ext
4659
Email
wasim.jafri@aku.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shahab Abid, MD
Organizational Affiliation
Aga Khan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aga Khan University
City
Karachi
State/Province
Sindh
ZIP/Postal Code
74800
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shahab Abid, MD
First Name & Middle Initial & Last Name & Degree
Wasim Jafri, MD
First Name & Middle Initial & Last Name & Degree
Maseeh Uzzaman, MD
First Name & Middle Initial & Last Name & Degree
Rakhshanda Bilal
First Name & Middle Initial & Last Name & Degree
Soobia Siddiqui, MD
First Name & Middle Initial & Last Name & Degree
Greger Lindberg, MD,PhD
12. IPD Sharing Statement
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Effect Of Itopride On Gastric Emptying And Accommodation In Patients With Functional Dyspepsia
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