Gastroesophageal Reflux DiseasePhase 4NCT03128736
Comparing Clinical Efficacy of One-Week Dual Delayed-Release Dexlansoprazole and Esomeprazole for GERD Grade A and B
A Phase 4 study testing Esomeprazole group and Dexlansoprazole group in people with Gastroesophageal Reflux Disease, run by Kaohsiung Medical University Chung-Ho Memorial Hospital.
Trial summary
Rapid onset of proton-pump inhibitors to achieve a fast symptom is an unmet need in treating gastroesophageal reflux disease (GERD) but there was no report on the short-term clinical effects and timing to symptom relief comparing dexlansoprazole 60 mg to esomeprazole 40 mg. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Gastroesophageal Reflux Disease
- What is being tested?
- Esomeprazole group and Dexlansoprazole group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2014to 30 Mar 2016
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 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 were recruited
Who cannot join
- taking antisecretory agents, such as PPIs and histamine-2 receptor antagonists within 2 week prior to the endoscopy
- 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 dexlansoprazole or esomeprazole
- symptom score of a validated questionnaire (Chinese GERDQ) less than 12
About this study
Official title: A Pilot Study Comparing Clinical Efficacy of One-Week Dual Delayed-Release Dexlansoprazole 60 mg and Esomeprazole 40 mg for Gastroesophageal Reflux Disease Grade A and B
Rapid onset of proton-pump inhibitors to achieve a fast symptom is an unmet need in treating gastroesophageal reflux disease (GERD) but there was no report on the short-term clinical effects and timing to symptom relief comparing dexlansoprazole 60 mg to esomeprazole 40 mg. This pilot study aims to compare the one-week clinical effects of single doses of the two drugs in treating GERD patients.
Read the detailed description
A comparative study to different PPIs in pharmacokinetic change showing that after 12-24 hours post dose, mean percentage of time with pH > 4 and average of mean pH were greater for dexlansoprazole than esomeprazole . However, the study did not report the clinical effect after tablets used. There was no report on the short-term clinical effects and timing to symptom relief of gastroesophageal reflux disease (GERD) between dexlansoprazole 60 mg and esomeprazole 40 mg. Therefore, we conducted a randomized controlled, open-label, study to compare the 7-day clinical effects of single doses of dexlansoprazole 60 mg and esomeprazole 40 mg in for GERD.
- Conditions
- Gastroesophageal Reflux Disease
- Being tested
- Esomeprazole group, Dexlansoprazole group
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esomeprazole groupDrug
Also called Nexium
Esomeprazole 40mg qd
Dexlansoprazole groupDrug
Also called Dexilant
Dexlansoprazole 60mg qd
| Study group | Role | What they receive |
|---|---|---|
| dexlansoprazole group | Experimental | dexlansoprazole 60mg Receives: Drug: Dexlansoprazole group |
| esomeprazole group | Experimental | esomeprazole 40mg Receives: Drug: Esomeprazole group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of complete symptom resolution (CSR)
Evaluate the complete symptom resolution by questionnaire
Measured: 1 week after finishing study drug
Secondary outcomes (1)
Rate of symptom relapse
Symptom relapse is defined as (a) two or more episodes of reflux symptoms per week that impair the quality of life
Measured: 12 weeks after finishing study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2017
- Study start1 Apr 2014
- Primary completion28 Feb 2016
- Study completion30 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Deng-Chyang Wu, MD, PhD, Principal investigator, Kaohsiung Medical UniversitySeng-Kee Chuah, MD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03128736
- Sponsor's protocol ID
- KMUHIRB-2014-09-02(I)
- Status last verified
- Apr 2017
- First submitted
- 20 Apr 2017
- Last updated
- 25 Apr 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chiang HH, Wu DC, Hsu PI, Kuo CH, Tai WC, Yang SC, Wu KL, Yao CC, Tsai CE, Liang CM, Wang YK, Wang JW, Huang CF, Chuah SK; Taiwan Acid-Related Disease Study Group. Clinical efficacy of 60-mg dexlansoprazole and 40-mg esomeprazole after 24 weeks for the on-demand treatment of gastroesophageal reflux disease grades A and B: a prospective randomized trial. Drug Des Devel Ther. 2019 Apr 26;13:1347-1356. doi: 10.2147/DDDT.S193559. eCollection 2019.
PubMed 31118571
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Comparing Clinical Efficacy of One-Week Dual Delayed-Release Dexlansoprazole 60 mg and Esomeprazole 40 mg for Gastroesophageal Reflux Disease Grade A and B
- ClinicalTrials.gov ID
- NCT03128736
- Acronym / sponsor ID
- KMUHIRB-2014-09-02(I)
- Conditions
- Gastroesophageal Reflux Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 1 Apr 2014 (actual)
- Primary completion
- 28 Feb 2016 (actual)
- Study completion
- 30 Mar 2016 (actual)
- First posted
- 25 Apr 2017 (actual)
- 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.
Rapid onset of proton-pump inhibitors to achieve a fast symptom is an unmet need in treating gastroesophageal reflux disease (GERD) but there was no report on the short-term clinical effects and timing to symptom relief comparing dexlansoprazole 60 mg to esomeprazole 40 mg. This pilot study aims to compare the one-week clinical effects of single doses of the two drugs in treating GERD patients.
Detailed description
A comparative study to different PPIs in pharmacokinetic change showing that after 12-24 hours post dose, mean percentage of time with pH > 4 and average of mean pH were greater for dexlansoprazole than esomeprazole . However, the study did not report the clinical effect after tablets used. There was no report on the short-term clinical effects and timing to symptom relief of gastroesophageal reflux disease (GERD) between dexlansoprazole 60 mg and esomeprazole 40 mg. Therefore, we conducted a randomized controlled, open-label, study to compare the 7-day clinical effects of single doses of dexlansoprazole 60 mg and esomeprazole 40 mg in for GERD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dexlansoprazole group | Experimental | Drug: Dexlansoprazole groupdexlansoprazole 60mg |
| esomeprazole group | Experimental | Drug: Esomeprazole groupesomeprazole 40mg |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients 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 were recruited
Key exclusion criteria (7 listed)
- taking antisecretory agents, such as PPIs and histamine-2 receptor antagonists within 2 week prior to the endoscopy
- coexistence of peptic ulcer or gastrointestinal malignancies
- pregnancy
- coexistence of serious concomitant illness (for example, decompensated liver cirrhosis and uremia),
- previous gastric surgery
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 groupAlso: NexiumEsomeprazole 40mg qd | Drug | esomeprazole group |
| Dexlansoprazole groupAlso: DexilantDexlansoprazole 60mg qd | Drug | dexlansoprazole group |
Primary outcome
Rate of complete symptom resolution (CSR)
Time frame: 1 week after finishing study drug
Evaluate the complete symptom resolution by questionnaire
1 secondary outcome
Rate of symptom relapse
Time frame: 12 weeks after finishing study drug
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 25 Apr 2017.
- Derived from this study: PubMed 31118571Chiang HH, Wu DC, Hsu PI, Kuo CH, Tai WC, Yang SC, Wu KL, Yao CC, Tsai CE, Liang CM, Wang YK, Wang JW, Huang CF, Chuah SK; Taiwan Acid-Related Disease Study Group. Clinical efficacy of 60-mg dexlansoprazole and 40-mg esomeprazole after 24 weeks for the on-demand treatment of gastroesophageal reflux disease grades A and B: a prospective randomized trial. Drug Des Devel Ther. 2019 Apr 26;13:1347-1356. doi: 10.2147/DDDT.S193559. eCollection 2019.
- Individual participant dataSharing planned: No
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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.
Deng-Chyang Wu, MD, PhD principal investigator
Kaohsiung Medical University
Seng-Kee Chuah, MD principal investigator
Chang Gung Memorial Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Esomeprazole group and Dexlansoprazole group in people with Gastroesophageal Reflux Disease, run by Kaohsiung Medical University Chung-Ho Memorial Hospital.
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 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 25 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Rate of complete symptom resolution (CSR) (time frame: 1 week after finishing study drug). 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 NCT03128736, 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 25 Apr 2017.