Peptic Ulcer/ErosionsPhase 4NCT00843063
Famotidine Compared With Pantoprazole to Prevent Recurrent Aspirin-Induced Peptic Ulcer/Erosion
A Phase 4 study testing pantoprazole vs famotidine in people with Peptic Ulcer/Erosions, run by Ruttonjee Hospital at 1 site in China.
Trial summary
Low-dose aspirin can prevent cerebral and cardiovascular accidents in individuals with symptomatic atherothrombotic disease, but its use is frequently limited by gastrointestinal side effects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peptic Ulcer/Erosions
- What is being tested?
- pantoprazole vs famotidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- 1 siteChina
- Study dates
- Aug 2004to Dec 2008
- 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
- upper GIB or dyspepsia due to peptic ulcers / erosions while receiving low-dose aspirin with a daily dose ranging from 80 mg to 320 mg
- endoscopy revealed a gastric or duodenal ulcers of 3 mm or more in diameter with unequivocal depth, or more than 5 erosions in the stomach or duodenum
- they required continuous low-dose aspirin for the secondary prevention of coronary heart disease, peripheral vascular disease and ischemic stroke or transient ischemic attacks
- 18 years old or older.
Who cannot join
- concurrent erosive or ulcerative esophagitis
- pyloric stenosis
- previous gastric or duodenal surgery other than oversewing of a perforation
- thrombocytopenia
- renal failure with estimated creatinine clearance less than 10 ml / min
- active cancer
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- known allergic to aspirin, famotidine or pantoprazole
- pregnancy, lactation, child-bearing potential in the absence of contraception
- psychosomatic disorder
- planned co-prescription of nonsteriodal anti-inflammatory drugs corticosteriod, or anticoagulant
- disorders that might modify the absorption of study drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Famotidine vs. Pantoprazole to Prevent Recurrent Aspirin-Induced Peptic Ulcer/Erosion - a Randomized Controlled Study
Low-dose aspirin can prevent cerebral and cardiovascular accidents in individuals with symptomatic atherothrombotic disease, but its use is frequently limited by gastrointestinal side effects.
The position of H2-receptor antagonists as a step-down therapy after healing of peptic ulcer or erosions by proton pump inhibitor is unclear.
The objective of this randomized, double blinded control study was to compare the efficacy of high-dose famotidine with pantoprazole in the prevention of recurrent dyspeptic or complicated ulcer/ erosions in patients taking low-dose aspirin
Read the detailed description
Low-dose aspirin can prevent cerebral and cardiovascular accidents in individuals with symptomatic atherothrombotic disease . Its use is frequently limited by gastrointestinal side effects, ranging from dyspepsia (31%) to life-threatening bleeding or perforation of gastroduodenal ulcers (3.1%) over a period of 4 years .
The best approach for the secondary prevention of low-dose aspirin induced symptomatic peptic ulcer or erosions in patients who need to continue aspirin remain uncertain. At present, eradication of Helicobacter pylori infection and long-term maintenance with proton pump inhibitor PPI appears to be the best options.
The position of H2-receptor antagonists (H2RA) as a step-down therapy after healing of peptic ulcer or erosions is unclear.
The objective of this randomized, double blinded control study was to compare the efficacy of high-dose famotidine with pantoprazole in the prevention of recurrent dyspeptic or complicated ulcer/ erosions in patients taking low-dose aspirin.
- Conditions
- Peptic Ulcer/Erosions
- Being tested
- pantoprazole vs famotidine
- Keywords
- pantoprazole, famotidine, aspirin, dyspepsia, gastrointestinal bleeding, peptic ulcer / erosion
- Medical subject headings
- Peptic Ulcer, Dyspepsia, Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pantoprazole vs famotidineDrug
Also called pantoloc, famotidine
pantoprazole 20 mg om and matching placebo nocte vs. famotidine 40 mg om and nocte
| Study group | Role | What they receive |
|---|---|---|
| pantoprazole | Active comparator | pantoprazole 20 mg om and matching placebo nocte Receives: Drug: pantoprazole vs famotidine |
| famotidine | Active comparator | Famotidine 40 mg om and nocte Receives: Drug: pantoprazole vs famotidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary end-point was the recurrence of dyspeptic or complicated ulcer / erosions.
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2009 (estimated)
- Study startAug 2004
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peptic Ulcer/ErosionsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruttonjee Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Fook Hong Ng, M.D., Principal investigator, Department of Medicine, Ruttonjee Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00843063
- Sponsor's protocol ID
- HKEC 2004-016
- Status last verified
- Feb 2009
- First submitted
- 12 Feb 2009
- Last updated
- 13 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Famotidine vs. Pantoprazole to Prevent Recurrent Aspirin-Induced Peptic Ulcer/Erosion - a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT00843063
- Acronym / sponsor ID
- HKEC 2004-016
- Conditions
- Peptic Ulcer/Erosions
- Keywords
- pantoprazole, famotidine, aspirin, dyspepsia, gastrointestinal bleeding, peptic ulcer / erosion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Ruttonjee HospitalUniversity, hospital or other
- Study start
- Aug 2004
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 13 Feb 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.
Low-dose aspirin can prevent cerebral and cardiovascular accidents in individuals with symptomatic atherothrombotic disease, but its use is frequently limited by gastrointestinal side effects.
The position of H2-receptor antagonists as a step-down therapy after healing of peptic ulcer or erosions by proton pump inhibitor is unclear.
The objective of this randomized, double blinded control study was to compare the efficacy of high-dose famotidine with pantoprazole in the prevention of recurrent dyspeptic or complicated ulcer/ erosions in patients taking low-dose aspirin
Detailed description
Low-dose aspirin can prevent cerebral and cardiovascular accidents in individuals with symptomatic atherothrombotic disease . Its use is frequently limited by gastrointestinal side effects, ranging from dyspepsia (31%) to life-threatening bleeding or perforation of gastroduodenal ulcers (3.1%) over a period of 4 years .
The best approach for the secondary prevention of low-dose aspirin induced symptomatic peptic ulcer or erosions in patients who need to continue aspirin remain uncertain. At present, eradication of Helicobacter pylori infection and long-term maintenance with proton pump inhibitor PPI appears to be the best options.
The position of H2-receptor antagonists (H2RA) as a step-down therapy after healing of peptic ulcer or erosions is unclear.
The objective of this randomized, double blinded control study was to compare the efficacy of high-dose famotidine with pantoprazole in the prevention of recurrent dyspeptic or complicated ulcer/ erosions in patients taking low-dose aspirin.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pantoprazole | Active comparator | Drug: pantoprazole vs famotidinepantoprazole 20 mg om and matching placebo nocte |
| famotidine | Active comparator | Drug: pantoprazole vs famotidineFamotidine 40 mg om and nocte |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- upper GIB or dyspepsia due to peptic ulcers / erosions while receiving low-dose aspirin with a daily dose ranging from 80 mg to 320 mg
- endoscopy revealed a gastric or duodenal ulcers of 3 mm or more in diameter with unequivocal depth, or more than 5 erosions in the stomach or duodenum
- they required continuous low-dose aspirin for the secondary prevention of coronary heart disease, peripheral vascular disease and ischemic stroke or transient ischemic attacks
- 18 years old or older.
Key exclusion criteria (11 listed)
- concurrent erosive or ulcerative esophagitis
- pyloric stenosis
- previous gastric or duodenal surgery other than oversewing of a perforation
- thrombocytopenia
- renal failure with estimated creatinine clearance less than 10 ml / min
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 |
|---|---|---|
| pantoprazole vs famotidineAlso: pantoloc, famotidinepantoprazole 20 mg om and matching placebo nocte vs. famotidine 40 mg om and nocte | Drug | famotidine, pantoprazole |
Primary outcome
The primary end-point was the recurrence of dyspeptic or complicated ulcer / erosions.
Time frame: 48 weeks
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 13 Feb 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.
Fook Hong Ng, M.D. principal investigator
Department of Medicine, Ruttonjee Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing pantoprazole vs famotidine in people with Peptic Ulcer/Erosions, run by Ruttonjee Hospital at 1 site 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 4 inclusion and 11 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 13 Feb 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 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?
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?
The primary end-point was the recurrence of dyspeptic or complicated ulcer / erosions. (time frame: 48 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 13 Feb 2009.