Gastroesophageal Reflux DiseasePhase 3NCT00164840
Symptomatic Gastroesophageal Reflux Disease: Double Blind Randomized Controlled Study of On-demand Therapy Versus Maintenance Therapy
A Phase 3 study testing Esomeprazole in people with Gastroesophageal Reflux Disease, run by Chinese University of Hong Kong at 1 site in China.
Trial summary
Maintenance treatment with proton pump inhibitor (PPI) is the most widely recommended modality of treatment for long-term management of gastroesophageal reflux disease (GERD). Yet in clinical practice treatment is commonly given in short courses on as required basis during symptom flare up, particularly for patients… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastroesophageal Reflux Disease
- What is being tested?
- Esomeprazole
- How many people
- 244 participants
- Where
- 1 siteChina
- Study dates
- May 2003to Nov 2008
- Phase
- Phase 3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Weekly symptoms of heartburn or acid regurgitation of moderate severity as predominant complaint for at least 6 months
Who cannot join
- Erosive esophagitis
- Concomitant peptic ulcer disease
- Use of NSAID in recent 4 weeks (Low dose aspirin < 300 mg is allowed)
- Pregnant or lactating female
- Illiterate patient (who cannot administer questionnaire)
- Known hypersensitivity to PPI
Trial locations and contacts
1 site in 1 country.
About this study
Maintenance treatment with proton pump inhibitor (PPI) is the most widely recommended modality of treatment for long-term management of gastroesophageal reflux disease (GERD). Yet in clinical practice treatment is commonly given in short courses on as required basis during symptom flare up, particularly for patients with mild to moderate GERD.
On-demand therapy also has the potential advantage that patient does not need to take regular medications, thereby improving the quality of life. However, whether on-demand PPI therapy achieves similar efficacy of symptom control is uncertain.
The aim of this study is to compare the efficacy and quality of life of on-demand and maintenance PPI regimens in long-term management of non-erosive GERD patients. The investigators hypothesize that on-demand PPI treatment is as effective as maintenance PPI.
- Conditions
- Gastroesophageal Reflux Disease
- Being tested
- Esomeprazole
- Keywords
- GERD
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsomeprazoleDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment failure
Measured: 26 Weeks
Secondary outcomes (3)
Symptom score
Measured: 26 weeks
Quality of Life
Measured: 1 year
Number of days off treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startMay 2003
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 244 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Investigators
- Justin CY WU, MD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00164840
- Sponsor's protocol ID
- OG Study
- Status last verified
- Mar 2010
- First submitted
- 9 Sep 2005
- Last updated
- 30 Mar 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptomatic Gastroesophageal Reflux Disease: Double Blind Randomized Controlled Study of On-demand Therapy Versus Maintenance Therapy
- ClinicalTrials.gov ID
- NCT00164840
- Acronym / sponsor ID
- OG Study
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- GERD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 244 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- May 2003
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 14 Sep 2005 (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.
Maintenance treatment with proton pump inhibitor (PPI) is the most widely recommended modality of treatment for long-term management of gastroesophageal reflux disease (GERD). Yet in clinical practice treatment is commonly given in short courses on as required basis during symptom flare up, particularly for patients with mild to moderate GERD.
On-demand therapy also has the potential advantage that patient does not need to take regular medications, thereby improving the quality of life. However, whether on-demand PPI therapy achieves similar efficacy of symptom control is uncertain.
The aim of this study is to compare the efficacy and quality of life of on-demand and maintenance PPI regimens in long-term management of non-erosive GERD patients. The investigators hypothesize that on-demand PPI treatment is as effective as maintenance PPI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Weekly symptoms of heartburn or acid regurgitation of moderate severity as predominant complaint for at least 6 months
Key exclusion criteria (6 listed)
- Erosive esophagitis
- Concomitant peptic ulcer disease
- Use of NSAID in recent 4 weeks (Low dose aspirin < 300 mg is allowed)
- Pregnant or lactating female
- Illiterate patient (who cannot administer questionnaire)
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 |
|---|---|---|
| Esomeprazole | Drug | – |
Primary outcome
Treatment failure
Time frame: 26 Weeks
3 secondary outcomes
Symptom score
Time frame: 26 weeks
Quality of Life
Time frame: 1 year
Number of days off treatment
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 30 Mar 2010.
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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.
Justin CY WU, MD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Esomeprazole in people with Gastroesophageal Reflux Disease, run by Chinese University of Hong Kong 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 1 inclusion and 6 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 30 Mar 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 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Treatment failure (time frame: 26 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 30 Mar 2010.