Functional DyspepsiaEEHPDSNCT00772837
Effect of Eradication of Helicobacter Pylori on the Dyspeptic Symptoms
A study testing Omeprazole + Clarithromycin + Amoxycillin in people with Functional Dyspepsia and Helicobacter Pylori Infection, run by Aga Khan University at 1 site in Pakistan.
Trial summary
Helicobacter pylori eradication and its impact on symptoms in patients with non-ulcer dyspepsia remain controversial . Many studies have examined the effect of H. pylori eradication on dyspeptic symptoms, but the results have been conflicting and inconclusive, with as many studies yielding positive as negative… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Functional Dyspepsia, Helicobacter Pylori Infection
- What is being tested?
- Omeprazole + Clarithromycin + Amoxycillin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 370 participants
- Where
- 1 sitePakistan
- Study dates
- Aug 2006to Jan 2009
- 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
- Ambulatory adult males and non-pregnant females.
- Dyspeptic symptoms for at least 3 months.
- Normal endoscopic findings.
- H. Pylori positive on testing.
Who cannot join
- Patients with erosive and non erosive esophagitis.
- Barrette's esophagus.
- Duodenal Ulcer, Gastric Ulcer or gastric erosions.
- Patients with known sensitivity to antibiotics.
- Patients with severe concomitant systemic disease.
- Patients with upper GI surgery except cholecystectomy.
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- Females with pregnancy or breast-feeding.
- Malignancy
- Alarm symptoms such as bleeding per rectum, hematemesis, and severe weight loss.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Eradication of Helicobacter Pylori on the Dyspeptic Symptoms.
Helicobacter pylori eradication and its impact on symptoms in patients with non-ulcer dyspepsia remain controversial . Many studies have examined the effect of H. pylori eradication on dyspeptic symptoms, but the results have been conflicting and inconclusive, with as many studies yielding positive as negative results. Some studies have shown a significant (although weak) symptomatic improvement after H. pylori eradication, and while other yielding negative results. A recent Cochrane review has comprehensively demonstrated that H.pylori eradication therapy has a small but statistically significant effect in H.pylori positive non-ulcer dyspepsia. An economic model suggests this modest benefit may still be cost effective . However it is difficult to reconcile these results in areas with very high prevalence of H. pylori infection such as Pakistan since no such studies have been conducted in developing countries.
The investigators hypothesize that eradication of Helicobacter pylori (H. pylori) leads to a sustained improvement in symptoms of patients diagnosed with H. pylori associated functional (non-ulcer) dyspepsia.
- Being tested
- Omeprazole + Clarithromycin + Amoxycillin, Omeprazole + placebo antibiotics
- Keywords
- Functional Dyspepsia, Helicobacter Pylori eradication, Quality of Life, Dyspeptic Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omeprazole + Clarithromycin + AmoxycillinDrug
Omeprazole 20mg BID for 1 week along with Clarithromycin 500mg BD and Amoxycillin 1g BD for 1 week
Omeprazole + placebo antibioticsDrug
omeprazole 20 mg bid for 1 week along with placebo antibiotics for 1 week
| Study group | Role | What they receive |
|---|---|---|
| 1.H.Pylori Eradication Group | Experimental | The eradication group will receive triple therapy (omeprazole 20mg BID for 1 week along with Clarithromycin 500mg BID and Amoxycillin 1g BID) for 1 week for the eradication of H. pylori Receives: Drug: Omeprazole + Clarithromycin + Amoxycillin |
| 2.Control Placebo Group | Placebo comparator | The control group will receive omeprazole 20 mg BID for 1 week along with placebo antibiotics for 1 week Receives: Drug: Omeprazole + placebo antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Dyspeptic Symptoms after eradication of Helicobacter Pylori in Patients with Functional Dyspepsia
Measured: 1 year
Secondary outcomes (1)
To determine whether eradication of Helicobacter Pylori improves the quality of life in patients with Functional Dyspepsia i.Quality of life (QoL) assessment on the basis of SF-36.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2008 (estimated)
- Study startAug 2006
- Primary completionDec 2008
- Study completionJan 2009
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
- 370 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Investigators
- DR.SHAHAB ABID, MD, Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00772837
- Sponsor's protocol ID
- 602-Med/ERC-06
- Acronym
- EEHPDS
- Status last verified
- Nov 2009
- First submitted
- 14 Oct 2008
- Last updated
- 10 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Eradication of Helicobacter Pylori on the Dyspeptic Symptoms.
- ClinicalTrials.gov ID
- NCT00772837
- Acronym / sponsor ID
- EEHPDS / 602-Med/ERC-06
- Keywords
- Functional Dyspepsia, Helicobacter Pylori eradication, Quality of Life, Dyspeptic Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 370 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 15 Oct 2008 (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.
Helicobacter pylori eradication and its impact on symptoms in patients with non-ulcer dyspepsia remain controversial . Many studies have examined the effect of H. pylori eradication on dyspeptic symptoms, but the results have been conflicting and inconclusive, with as many studies yielding positive as negative results. Some studies have shown a significant (although weak) symptomatic improvement after H. pylori eradication, and while other yielding negative results. A recent Cochrane review has comprehensively demonstrated that H.pylori eradication therapy has a small but statistically significant effect in H.pylori positive non-ulcer dyspepsia. An economic model suggests this modest benefit may still be cost effective . However it is difficult to reconcile these results in areas with very high prevalence of H. pylori infection such as Pakistan since no such studies have been conducted in developing countries.
The investigators hypothesize that eradication of Helicobacter pylori (H. pylori) leads to a sustained improvement in symptoms of patients diagnosed with H. pylori associated functional (non-ulcer) dyspepsia.
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.H.Pylori Eradication Group | Experimental | Drug: Omeprazole + Clarithromycin + AmoxycillinThe eradication group will receive triple therapy (omeprazole 20mg BID for 1 week along with Clarithromycin 500mg BID and Amoxycillin 1g BID) for 1 week for the eradication of H. pylori |
| 2.Control Placebo Group | Placebo comparator | Drug: Omeprazole + placebo antibioticsThe control group will receive omeprazole 20 mg BID for 1 week along with placebo antibiotics for 1 week |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ambulatory adult males and non-pregnant females.
- Dyspeptic symptoms for at least 3 months.
- Normal endoscopic findings.
- H. Pylori positive on testing.
Key exclusion criteria (9 listed)
- Patients with erosive and non erosive esophagitis.
- Barrette's esophagus.
- Duodenal Ulcer, Gastric Ulcer or gastric erosions.
- Patients with known sensitivity to antibiotics.
- Patients with severe concomitant systemic disease.
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 |
|---|---|---|
| Omeprazole + Clarithromycin + AmoxycillinOmeprazole 20mg BID for 1 week along with Clarithromycin 500mg BD and Amoxycillin 1g BD for 1 week | Drug | 1.H.Pylori Eradication Group |
| Omeprazole + placebo antibioticsomeprazole 20 mg bid for 1 week along with placebo antibiotics for 1 week | Drug | 2.Control Placebo Group |
Primary outcome
Improvement in Dyspeptic Symptoms after eradication of Helicobacter Pylori in Patients with Functional Dyspepsia
Time frame: 1 year
1 secondary outcome
To determine whether eradication of Helicobacter Pylori improves the quality of life in patients with Functional Dyspepsia i.Quality of life (QoL) assessment on the basis of SF-36.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2009.
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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.
DR.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 Omeprazole + Clarithromycin + Amoxycillin in people with Functional Dyspepsia and Helicobacter Pylori Infection, 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 4 inclusion and 9 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: finished, as of the sponsor's last update on 10 Nov 2009. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in Dyspeptic Symptoms after eradication of Helicobacter Pylori in Patients with Functional Dyspepsia (time frame: 1 year). 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 10 Nov 2009.