Functional DyspepsiaEIGEAPFDNCT01226134
Effect Of Itopride On Gastric Emptying And Accommodation In Patients With Functional Dyspepsia
A study testing Itopride, in people with Functional Dyspepsia and Gastric Emptying, run by Aga Khan University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Functional Dyspepsia, Gastric Emptying, Gastric Accommodation
- What is being tested?
- Itopride,
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- Feb 2009to May 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Aga Khan University
Karachi, Sindh, 74800
Shahab Abid, MD
Wasim Jafri, MD
About this study
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.
Read more
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
Read the detailed description
phase3 clinical trial
- Being tested
- Itopride,, Placebo
- Keywords
- Functional Dyspepsia, Itopride, Gastric Emptying, Gastric Accommodation, Dyspeptic Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Itopride,Drug
Also called Gananton
Itopride,50 mg capsules,thrice a day,for Four weeks
PlaceboDrug
placebo capsules,thrice a day for four weeks
| Study group | Role | What they receive |
|---|---|---|
| 1.Itopride Group | Experimental | The itopride group will receive itopride 150mg per day(50mg TDS)for four weeks Receives: Drug: Itopride, |
| 2.Control placebo group | Placebo comparator | The control group will receive placebo tablets for four weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the effect of Itopride on Gastric Emptying,accommodation and capacity of tolerating a nutrient drink in patients with Functional Dyspepsia
Measured: 18 months
Secondary outcomes (1)
To assess the effect of Itopride on symptom improvement in patient with Functional Dyspepsia
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2010 (estimated)
- Study startFeb 2009
- Primary completionMar 2011 (estimated)
- Study completionMay 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional DyspepsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Investigators
- Shahab Abid, MD, Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01226134
- Sponsor's protocol ID
- 965-Med/ERC-08
- Acronym
- EIGEAPFD
- Status last verified
- Jul 2010
- First submitted
- 21 Oct 2010
- Last updated
- 22 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Itopride On Gastric Emptying And Accommodation In Patients With Functional Dyspepsia
- ClinicalTrials.gov ID
- NCT01226134
- Acronym / sponsor ID
- EIGEAPFD / 965-Med/ERC-08
- Keywords
- Functional Dyspepsia, Itopride, Gastric Emptying, Gastric Accommodation, Dyspeptic Symptoms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Mar 2011 (estimated)
- Study completion
- May 2011 (estimated)
- First posted
- 22 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1.Itopride Group | Experimental | Drug: Itopride,The itopride group will receive itopride 150mg per day(50mg TDS)for four weeks |
| 2.Control placebo group | Placebo comparator | Drug: PlaceboThe control group will receive placebo tablets for four weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Itopride,Also: GanantonItopride,50 mg capsules,thrice a day,for Four weeks | Drug | 1.Itopride Group |
| Placeboplacebo capsules,thrice a day for four weeks | Drug | 2.Control placebo group |
Primary outcome
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
1 secondary outcome
To assess the effect of Itopride on symptom improvement in patient with Functional Dyspepsia
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2010.
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Body Surface Gastric Mapping to Evaluate Patients With Upper Gastrointestinal Symptoms and Controls
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Efficacy of Clostridium Butyricum in Alleviating Anxiety and Depression in Patients With Functional Dyspepsia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shahab Abid, MD principal investigator
Aga Khan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Itopride, in people with Functional Dyspepsia and Gastric Emptying, run by Aga Khan University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shahab Abid, MD (+92 21 4864656 ext. 4656, shahab.abid@aku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2010.