AspirinPhase 4NCT00978159
Esomeprazole or Famotidine in the Management of Aspirin Related Non-Ulcer Dyspepsia
A Phase 4 study testing esomeprazole and Famotidine in people with Aspirin and Dyspepsia, run by Ruttonjee Hospital at 2 sites in China.
Trial summary
Aspirin can prevent ischemic vascular disease but is commonly complicated by dyspepsia in 30% of patients. Patients, who have aspirin related dyspepsia, commonly underwent upper endoscopy to exclude peptic ulcer disease or gastric cancers. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- esomeprazole and Famotidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 2 sitesChina
- Study dates
- Sep 2009to Dec 2013
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- at least moderate pain or discomfort (or both) centered in the upper abdomen as their predominant symptoms for 7 days before randomization; taking low dose aspirin (80-300 mg daily),and insignificant upper endoscopic finding. At least moderate pain or discomfort is defined if the HKDI was more than or equal to 16.
- H. Pylori: In patients with have successful eradication of H. pylori and had dyspepsia with HKDI >=16 at the 6th week after eradication therapy can be recruited.In patients without H. pylori infection, they can be recruited immediately.
Who cannot join
- non-Chinese speaking
- significant endoscopic finding
- typical biliary colic
- predominant heartburn or symptoms of the irritable bowel syndrome
- a history of peptic ulcer or gastroesophageal reflux
- unintentional weight loss previous gastric or duodenal surgery
Show all 16Show fewer
- thrombocytopenia
- renal failure with estimated creatinine clearance less than 10 ml/min
- active cancer
- known allergic to aspirin, famotidine or esomeprazole
- pregnancy, lactation, child-bearing potential in the absence of contraception
- planned co-prescription of nonsteroidal anti-inflammatory drugs
- corticosteroid, clopidogrel or anticoagulant
- anxiety neurosis, depression, psychosomatic disorder
- investigation for dyspepsia with endoscopy or barium series before aspirin therapy or disorders that might modify the absorption of study drugs
- ongoing treatment with a histamine H2-receptor antagonist, a prostaglandin, or a prokinetic drug during the 7 days before enrollment was not permitted, nor was treatment with a proton-pump inhibitor, or bismuth in the 30 days before enrollment
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Ruttonjee Hospital
Hong Kong
FH Ng, MD, 22911743
- Recruiting
Queen Mary Hospital
Pokfulam, Hong Kong
Ivan Hung, 28551111
About this study
Official title: Esomeprazole or Famotidine in the Management of Aspirin Related Non-ulcer Dyspepsia - a Double Blind Randomized Control Study
Aspirin can prevent ischemic vascular disease but is commonly complicated by dyspepsia in 30% of patients. Patients, who have aspirin related dyspepsia, commonly underwent upper endoscopy to exclude peptic ulcer disease or gastric cancers. For those without significant lesions in the stomach and duodenum (non-ulcer dyspepsia), the best approach in the management is unclear. The objective of this study is to compare the efficacy of esomeprazole and famotidine in the control of dyspeptic symptom. After giving consent, patients will be randomised to receive either esomeprazole 20 mg daily or famotidine 40 mg daily in a double blinded manner. The patient will be followed-up at the 2nd and 4th week. The study will be completed at the 4th week. The primary analysis will be the efficacy in the control of dyspepsia symptom between the two groups.
Read the detailed description
The objective of this double blinded randomized controlled study is to compare the efficacy of esomeprazole with famotidine in the control of dyspepsia in patients with aspirin related nonulcer dyspepsia NUD.
Method
The study shall be applied for approval from the Ethic Committee of Hong Kong West and East Cluster and shall be registered to the Clinical Trial Governance before the recruitment of the first patient.
Measuring instruments \& Definitions
Hong Kong Dyspepsia Index (HKDI)
The presence or absence of dyspepsia was measured by the validated Hong Kong index of dyspepsia . This questionnaire could be used in epidemiological studies assessing the frequency and severity of dyspepsia in patient populations and also in interventional studies in functional dyspepsia.This index consisted of 12 questions on the severity of gastrointestinal symptoms, graded according to a five-point Likert scale (1- 5, from asymptomatic to very severe symptoms). A cut-off score of equal to or greater than 16 was determined to discriminate between controls and dyspeptic patients.
Global Dyspepsia Score
The global severity of dyspepsia will be measured by the Global Dyspepsia Score, which was a four-point scale in which a score of 0 indicated no pain or discomfort, a score of 1 mild pain or discomfort, a score of 2 moderate (annoying but not interfering with the daily routine) pain or discomfort, and a score of 3 severe (markedly interfering with the daily routine) pain or discomfort over the last 7 days . This scale is reliable, valid, and responsive and provides global assessment of symptoms in the western population . Significant dyspepsia was defined when Global Dyspepsia Score was more than or equal to 2 moderate.
Definition of significant endoscopic finding
Significant finding was defined as the presence of reflux esophagitis, Barrett's esophagus, gastric or duodenal ulceration, duodenal or esophageal erosions, or cancer and those with more than five gastric erosions on upper endoscopy. (Tally N, NEJM 1999)
- Being tested
- esomeprazole, Famotidine
- Keywords
- esomeprazole, famotidine, aspirin, dyspepsia
- Medical subject headings
- Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
esomeprazoleDrug
esomeprazole 20 mg po for 4 weeks
FamotidineDrug
Famotidine 40 mg po for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| esomeprazole | Active comparator | esomeprazole 20 mg Receives: Drug: esomeprazole |
| Famotidine | Active comparator | famotidine 40 mg Receives: Drug: Famotidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment success : The HKDI is less than 16. Treatment was considered to have failed if a patient had taken medication for dyspepsia (other than antacids) during the study period
Measured: 4 weeks
Secondary outcomes (1)
Treatment success: no significant dyspepsia defined by the Global Dyspepsia Score
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AspirinStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruttonjee Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Queen Mary Hospital, Hong Kong
- Responsible party
- Principal investigator, Fook-Hong Ng, Ruttonjee Hospital
- Investigators
- FH Ng, MD, Principal investigator, Ruttonjee Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00978159
- Sponsor's protocol ID
- HKEC 2009-058
- Status last verified
- Jun 2012
- First submitted
- 15 Sep 2009
- Last updated
- 6 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Esomeprazole or Famotidine in the Management of Aspirin Related Non-ulcer Dyspepsia - a Double Blind Randomized Control Study
- ClinicalTrials.gov ID
- NCT00978159
- Acronym / sponsor ID
- HKEC 2009-058
- Keywords
- esomeprazole, famotidine, aspirin, dyspepsia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Ruttonjee HospitalUniversity, hospital or other
- Collaborators
- Queen Mary Hospital, Hong Kong
- Study start
- Sep 2009
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 16 Sep 2009 (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.
Aspirin can prevent ischemic vascular disease but is commonly complicated by dyspepsia in 30% of patients. Patients, who have aspirin related dyspepsia, commonly underwent upper endoscopy to exclude peptic ulcer disease or gastric cancers. For those without significant lesions in the stomach and duodenum (non-ulcer dyspepsia), the best approach in the management is unclear. The objective of this study is to compare the efficacy of esomeprazole and famotidine in the control of dyspeptic symptom. After giving consent, patients will be randomised to receive either esomeprazole 20 mg daily or famotidine 40 mg daily in a double blinded manner. The patient will be followed-up at the 2nd and 4th week. The study will be completed at the 4th week. The primary analysis will be the efficacy in the control of dyspepsia symptom between the two groups.
Detailed description
The objective of this double blinded randomized controlled study is to compare the efficacy of esomeprazole with famotidine in the control of dyspepsia in patients with aspirin related nonulcer dyspepsia NUD.
Method
The study shall be applied for approval from the Ethic Committee of Hong Kong West and East Cluster and shall be registered to the Clinical Trial Governance before the recruitment of the first patient.
Measuring instruments \& Definitions
Hong Kong Dyspepsia Index (HKDI)
The presence or absence of dyspepsia was measured by the validated Hong Kong index of dyspepsia . This questionnaire could be used in epidemiological studies assessing the frequency and severity of dyspepsia in patient populations and also in interventional studies in functional dyspepsia.This index consisted of 12 questions on the severity of gastrointestinal symptoms, graded according to a five-point Likert scale (1- 5, from asymptomatic to very severe symptoms). A cut-off score of equal to or greater than 16 was determined to discriminate between controls and dyspeptic patients.
Global Dyspepsia Score
The global severity of dyspepsia will be measured by the Global Dyspepsia Score, which was a four-point scale in which a score of 0 indicated no pain or discomfort, a score of 1 mild pain or discomfort, a score of 2 moderate (annoying but not interfering with the daily routine) pain or discomfort, and a score of 3 severe (markedly interfering with the daily routine) pain or discomfort over the last 7 days . This scale is reliable, valid, and responsive and provides global assessment of symptoms in the western population . Significant dyspepsia was defined when Global Dyspepsia Score was more than or equal to 2 moderate.
Definition of significant endoscopic finding
Significant finding was defined as the presence of reflux esophagitis, Barrett's esophagus, gastric or duodenal ulceration, duodenal or esophageal erosions, or cancer and those with more than five gastric erosions on upper endoscopy. (Tally N, NEJM 1999)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| esomeprazole | Active comparator | Drug: esomeprazoleesomeprazole 20 mg |
| Famotidine | Active comparator | Drug: Famotidinefamotidine 40 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- at least moderate pain or discomfort (or both) centered in the upper abdomen as their predominant symptoms for 7 days before randomization; taking low dose aspirin (80-300 mg daily),and insignificant upper endoscopic finding. At least moderate pain or discomfort is defined if the HKDI was more than or equal to 16.
- H. Pylori: In patients with have successful eradication of H. pylori and had dyspepsia with HKDI >=16 at the 6th week after eradication therapy can be recruited.In patients without H. pylori infection, they can be recruited immediately.
Key exclusion criteria (16 listed)
- non-Chinese speaking
- significant endoscopic finding
- typical biliary colic
- predominant heartburn or symptoms of the irritable bowel syndrome
- a history of peptic ulcer or gastroesophageal reflux
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 |
|---|---|---|
| esomeprazoleesomeprazole 20 mg po for 4 weeks | Drug | esomeprazole |
| FamotidineFamotidine 40 mg po for 4 weeks | Drug | Famotidine |
Primary outcome
Treatment success : The HKDI is less than 16. Treatment was considered to have failed if a patient had taken medication for dyspepsia (other than antacids) during the study period
Time frame: 4 weeks
1 secondary outcome
Treatment success: no significant dyspepsia defined by the Global Dyspepsia Score
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2012.
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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.
FH Ng, MD principal investigator
Ruttonjee Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing esomeprazole and Famotidine in people with Aspirin and Dyspepsia, run by Ruttonjee Hospital at 2 sites in China.
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 2 inclusion and 16 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 6 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 FH Ng, M.D. (22911743, ngfhong@hkucc.hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment success : The HKDI is less than 16. Treatment was considered to have failed if a patient had taken medication for dyspepsia (other than antacids) during the study period (time frame: 4 weeks). 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 6 Jun 2012.