Erosive EsophagitisPhase 4NCT01874535
Rate of Complete Symptom Relief, Prevention of Symptom Relapse: Grades A and B Esophagitis of Esomeprazole Therapy
A Phase 4 study testing Esomeprazole 40 mg in people with Erosive Esophagitis, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
To investigate the impact of initial treatment duration (4-week versus 8-week)of Esomeprazole (40mg) on the rate of symptom relapse and sustained healing of esophagitis in patients with symptomatic erosive esophagitis Read more about this study
- Who is it for?
- Ages 15 to 80 years
- Conditions the study is for
- Erosive Esophagitis
- What is being tested?
- Esomeprazole 40 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 408 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2010to Jun 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 15 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients between the ages of 15 and 80 years
- with clinical symptoms of acid regurgitation, heart burn, or feeling of acidity in the stomach,
- who have Los Angeles Grade A and B erosive esophagitis proven by endoscopy are recruited.
Who cannot join
- coexistence of peptic ulcer or gastrointestinal malignancies,
- pregnancy,
- coexistence of serious concomitant illness (for example, decompensated liver cirrhosis and uremia),
- previous gastric surgery,
- allergy to esomeprazole,
- symptom score of a validated questionnaire (Chinese GERDQ) less than 12, and
- equivocal endoscopic diagnosis of Los Angeles Grade A and B erosive esophagitis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Rates of Complete Symptom Relief,Prevetion of Symptom Relapse and Maintenance of Esophagitis Healing for 4-week Versus 8-week Esomeprazole Therapy Among Los Angeles Grades A and B Erosive Esophagitis
To investigate the impact of initial treatment duration (4-week versus 8-week)of Esomeprazole (40mg) on the rate of symptom relapse and sustained healing of esophagitis in patients with symptomatic erosive esophagitis
Read the detailed description
Patients:
Patients between the ages of 15 and 80 years with clinical symptoms of acid regurgitation, heart burn, or feeling of acidity in the stomach, who have Los Angeles Grade A and B erosive esophagitis proven by endoscopy are recruited. Criteria for exclusions include (1) coexistence of peptic ulcer or gastrointestinal malignancies, (2) pregnancy, (3) coexistence of serious concomitant illness (for example, decompensated liver cirrhosis and uremia), (4) previous gastric surgery, (5) allergy to esomeprazole, (6) symptom score of a validated questionnaire (Chinese GERDQ) less than 12, and (7) equivocal endoscopic diagnosis of Los Angeles Grade A and B erosive esophagitis.
Outcome parameters:
The main outcome measures
- Rate of complete symptom relief (CSR) at the end of initial treatment phase
- rate of symptom relapse within 12 weeks after stopping initial therapy
- Conditions
- Erosive Esophagitis
- Being tested
- Esomeprazole 40 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esomeprazole 40 mgDrug
Also called Nexium 40mg
Comparison of 4-weeks and 8-weeks initial treatment duration of esomeprazole 40 mg per day on the rate of symptom relapse and sustained healing of esophagitis in patients with symptomatic erosive esophagitis
| Study group | Role | What they receive |
|---|---|---|
| GERD Los Angeles A and B-4 week group | Active comparator | Patients with Los Angeles A and B esophagitis prescribed with esomeprazole (40 mg)daily- 4 week group Receives: Drug: Esomeprazole 40 mg |
| GERD Los Angeles A and B-8-week group | Active comparator | Patients with Los Angeles A and B esophagitis prescribed with esomeprazole (40 mg)daily- 8 week group Receives: Drug: Esomeprazole 40 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Rates of Complete Symptom Relief
Rate of complete symptom relief (CSR) at the end of initial treatment phase
Measured: at the 20 weeks after the end of initial treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2013 (estimated)
- Study startJun 2010
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Erosive EsophagitisStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 408 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei-Chen Tai M.D., Chang Gung Memorial Hospital
- Investigators
- Seng-Kee Chuah, M.D, Study chair, Kaohsiung Chang Gung Memorial Hospital,Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01874535
- Sponsor's protocol ID
- GERD A and B
- Status last verified
- Jun 2017
- First submitted
- 4 Nov 2012
- Last updated
- 4 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: The data will be shared in July 2017
Publications
Hsu PI, Lu CL, Wu DC, Kuo CH, Kao SS, Chang CC, Tai WC, Lai KH, Chen WC, Wang HM, Cheng JS, Tsai TJ, Chuah SK. Eight weeks of esomeprazole therapy reduces symptom relapse, compared with 4 weeks, in patients with Los Angeles grade A or B erosive esophagitis. Clin Gastroenterol Hepatol. 2015 May;13(5):859-66.e1. doi: 10.1016/j.cgh.2014.09.033. Epub 2014 Sep 20.
PubMed 25245625
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Rates of Complete Symptom Relief,Prevetion of Symptom Relapse and Maintenance of Esophagitis Healing for 4-week Versus 8-week Esomeprazole Therapy Among Los Angeles Grades A and B Erosive Esophagitis
- ClinicalTrials.gov ID
- NCT01874535
- Acronym / sponsor ID
- GERD A and B
- Conditions
- Erosive Esophagitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 408 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 11 Jun 2013 (estimated)
- Results
- Posted 4 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the impact of initial treatment duration (4-week versus 8-week)of Esomeprazole (40mg) on the rate of symptom relapse and sustained healing of esophagitis in patients with symptomatic erosive esophagitis
Detailed description
Patients:
Patients between the ages of 15 and 80 years with clinical symptoms of acid regurgitation, heart burn, or feeling of acidity in the stomach, who have Los Angeles Grade A and B erosive esophagitis proven by endoscopy are recruited. Criteria for exclusions include (1) coexistence of peptic ulcer or gastrointestinal malignancies, (2) pregnancy, (3) coexistence of serious concomitant illness (for example, decompensated liver cirrhosis and uremia), (4) previous gastric surgery, (5) allergy to esomeprazole, (6) symptom score of a validated questionnaire (Chinese GERDQ) less than 12, and (7) equivocal endoscopic diagnosis of Los Angeles Grade A and B erosive esophagitis.
Outcome parameters:
The main outcome measures
- Rate of complete symptom relief (CSR) at the end of initial treatment phase
- rate of symptom relapse within 12 weeks after stopping initial therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GERD Los Angeles A and B-4 week group | Active comparator | Drug: Esomeprazole 40 mgPatients with Los Angeles A and B esophagitis prescribed with esomeprazole (40 mg)daily- 4 week group |
| GERD Los Angeles A and B-8-week group | Active comparator | Drug: Esomeprazole 40 mgPatients with Los Angeles A and B esophagitis prescribed with esomeprazole (40 mg)daily- 8 week group |
Who may qualify
- Ages
- 15 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- patients between the ages of 15 and 80 years
- with clinical symptoms of acid regurgitation, heart burn, or feeling of acidity in the stomach,
- who have Los Angeles Grade A and B erosive esophagitis proven by endoscopy are recruited.
Key exclusion criteria (7 listed)
- coexistence of peptic ulcer or gastrointestinal malignancies,
- pregnancy,
- coexistence of serious concomitant illness (for example, decompensated liver cirrhosis and uremia),
- previous gastric surgery,
- allergy to esomeprazole,
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 40 mgAlso: Nexium 40mgComparison of 4-weeks and 8-weeks initial treatment duration of esomeprazole 40 mg per day on the rate of symptom relapse and sustained healing of esophagitis in patients with symptomatic erosive esophagitis | Drug | GERD Los Angeles A and B-4 week group, GERD Los Angeles A and B-8-week group |
Primary outcome
The Rates of Complete Symptom Relief
Time frame: at the 20 weeks after the end of initial treatment.
Rate of complete symptom relief (CSR) at the end of initial treatment phase
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25245625Hsu PI, Lu CL, Wu DC, Kuo CH, Kao SS, Chang CC, Tai WC, Lai KH, Chen WC, Wang HM, Cheng JS, Tsai TJ, Chuah SK. Eight weeks of esomeprazole therapy reduces symptom relapse, compared with 4 weeks, in patients with Los Angeles grade A or B erosive esophagitis. Clin Gastroenterol Hepatol. 2015 May;13(5):859-66.e1. doi: 10.1016/j.cgh.2014.09.033. Epub 2014 Sep 20.
- Individual participant dataSharing planned: Yes. The data will be shared in July 2017
Related trials for Erosive Esophagitis
Not yet recruitingPhase 4
PPI Dosing Per CYP2C19 Genotype
Gastroesophageal Reflux Disease With Esophagitis
RecruitingObservational study
A Study of the Safety of Vonoprazan Exposure in Pregnant Women and Their Offspring
Erosive Esophagitis, Heartburn
Recruiting
Neuroregulators for the Treatment of Diseases Associated With Esophageal-brain-gut Axis Communication Abnormalities.
Gut-Brain Disorders, GERD Without Erosive Esophagitis
Recruiting
Cognitive-behavioral Therapy for the Diseases Associated With Esophageal-brain-gut Axis Communication Abnormalities.
Gut-Brain Disorders, GERD Without Erosive Esophagitis
Not yet recruitingPhase 3
Efficacy and Safety of DWP14012 for Long-Term Maintenance Therapy in Patients With Healed Erosive Esophagitis
Healed Erosive Esophagitis
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.
Seng-Kee Chuah, M.D study chair
Kaohsiung Chang Gung Memorial Hospital,Taiwan
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 Esomeprazole 40 mg in people with Erosive Esophagitis, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 3 inclusion and 7 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 4 Sep 2018. 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 Taiwan. 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?
Yes. Results are posted in the registry (first posted 4 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Rates of Complete Symptom Relief (time frame: at the 20 weeks after the end of initial treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01874535, which also lists 1 linked publication.
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 4 Sep 2018.