Non-erosive Reflux DiseasePhase 2NCT01750437
Phase 2 Clinical Trial to Investigate the Safety, Tolerability and Efficacy of YH1885L in Patients With Non-erosive Reflux Disease(NERD)
A Phase 2 study testing YH1885L(Revaprazan) and Esomeprazole 20mg in people with Non-erosive Reflux Disease, run by Yuhan Corporation at 10 sites in South Korea.
Trial summary
Randomized, double-blind, active-controlled, multi-center phase 2 clinical trial to investigate the safety, tolerability and efficacy of YH1885L in patients with non-erosive reflux disease(NERD) Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Non-erosive Reflux Disease
- What is being tested?
- YH1885L(Revaprazan) and Esomeprazole 20mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 149 participants
- Where
- 10 sitesSouth Korea
- Study dates
- Jan 2013to Apr 2014
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- subjects who signed written informed consent form
- more than 20 yr subject
- subjects who agree the use of medically accepted birth control during trial
- grade N, M by EGD test
- subject who experience 2 day out of 1 week during recent 1 month
- subject who experience 2 day out of 1 week during run-in period
Who cannot join
- subjects who can write the diary by himself, herself
- pregnant woman, breastfeeding woman
- allgeric or intolerabiliy to revaprazan or esomeprazole
- feeling of heavy stomach, distention
- surgery history in stomach or esophagus
- active medical history of stomach, esophagus area
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- other system disorder which can disturb this trial
- Hep B, C virus, HIV carrier or patients
- past history of malignant tumor
- any psychiatric past or current history
- abnormal lab test
- abnormal ecg test
- zollinger-ellison disease
- current or past history of substance, drug abuse
- subject who should regulary takes medication which can disturb this trial
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
South Korea10 sites
DongA university hospital
Busan
Kyungbook University hospital
Daegu
Chungnam university hospital
Daejeon
Catholic Incheon hospital
Incheon
Jeonbuk University hospital
Jeonju
Catholic yeouido sungmo hospital
Seoul, Seoul
Asan hospital
Seoul
Konkuk unversity hospital
Seoul
Kyunghee university hospital
Seoul
Seoul university hospital
Seoul
About this study
Official title: Randomized, Double-blind, Active-controlled, Multi-center Phase 2 Clinical Trial to Investigate the Safety, Tolerability and Efficacy of YH1885L in Patients With Non-erosive Reflux Disease(NERD)
Randomized, double-blind, active-controlled, multi-center phase 2 clinical trial to investigate the safety, tolerability and efficacy of YH1885L in patients with non-erosive reflux disease(NERD)
- Conditions
- Non-erosive Reflux Disease
- Being tested
- YH1885L(Revaprazan), Esomeprazole 20mg, placebo
- Keywords
- NERD
- Medical subject headings
- Non-Erosive Reflux Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YH1885L(Revaprazan)Drug
Esomeprazole 20mgDrug
Also called Nexium
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| YH1885L 33.3 mg | Experimental | TID, Subject takes it for 4 week. Receives: Drug: YH1885L(Revaprazan) |
| YH1885L 50mg | Experimental | BID, Subject takes it for 4 week. Receives: Drug: YH1885L(Revaprazan); Drug: placebo |
| YH1885L 66.6 mg | Experimental | TID, Subject takes it for 4 week. Receives: Drug: YH1885L(Revaprazan) |
| YH1885L 100mg | Experimental | BID, Subject takes it for 4 week. Receives: Drug: YH1885L(Revaprazan); Drug: placebo |
| Esomeprazole 20mg | Active comparator | QD, Subject takes it for 4 week. Receives: Drug: Esomeprazole 20mg; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
the rate of subject who had 'complete recovery' of symptom after 4 week administration
'complete recovery' means subjects never experience heartburn or acid regurgitation during last 1 week.
Measured: 4 week
Secondary outcomes (10)
the rate of subject who had 'appropriate recovery' of symptom after 4 week administration
'Appropriate recovery' means subjects experience heartburn or acid regurgitation only 1 or less during last 1 week.
Measured: 4 week
the rate of subject who had 'complete recovery' after 1 week, 2 week, 3 week IP administraion
Measured: 3 week
the rate of subject who had 'appropriate recovery' after 1 week, 2 week, 3 week IP administraion
Measured: 3 week
the number of night symptom-free day after IP administration
Symptoms means "Heartburn or Acid regurgitation"
Measured: 1 week, 2 week, 3 week, 4 week
the rate of subjects who have reduced average symptom score(more than 1) comparing to baseline score
Measured: 1 week, 2 week, 3 week, 4 week
Evalution of Clinical Global Impression of Change
Measured: 4 week
Evaluation of Patient Global Impression of Change
Measured: 4 week
the change of SF-36 Survey score between baseline and completion visit
Measured: 4 week
the change of ESS survey score among baseline, 2 week and 4 week
ESS stands for Epworth sleepiness scale.
Measured: 2, 4 week
Safety
AE, Physical exam, 12-lead ECG, Vital signs, laboratory test
Measured: 4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2012 (estimated)
- Study startJan 2013
- Primary completionOct 2013
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-erosive Reflux DiseaseStudies of the same condition, open and under way.
- More trials run by Yuhan CorporationThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuhan Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01750437
- Sponsor's protocol ID
- YH1885L-201
- Status last verified
- Jul 2014
- First submitted
- 12 Dec 2012
- Last updated
- 10 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Active-controlled, Multi-center Phase 2 Clinical Trial to Investigate the Safety, Tolerability and Efficacy of YH1885L in Patients With Non-erosive Reflux Disease(NERD)
- ClinicalTrials.gov ID
- NCT01750437
- Acronym / sponsor ID
- YH1885L-201
- Conditions
- Non-erosive Reflux Disease
- Keywords
- NERD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Yuhan CorporationIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 17 Dec 2012 (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.
Randomized, double-blind, active-controlled, multi-center phase 2 clinical trial to investigate the safety, tolerability and efficacy of YH1885L in patients with non-erosive reflux disease(NERD)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| YH1885L 33.3 mg | Experimental | Drug: YH1885L(Revaprazan)TID, Subject takes it for 4 week. |
| YH1885L 50mg | Experimental | Drug: YH1885L(Revaprazan), Drug: placeboBID, Subject takes it for 4 week. |
| YH1885L 66.6 mg | Experimental | Drug: YH1885L(Revaprazan)TID, Subject takes it for 4 week. |
| YH1885L 100mg | Experimental | Drug: YH1885L(Revaprazan), Drug: placeboBID, Subject takes it for 4 week. |
| Esomeprazole 20mg | Active comparator | Drug: Esomeprazole 20mg, Drug: placeboQD, Subject takes it for 4 week. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- subjects who signed written informed consent form
- more than 20 yr subject
- subjects who agree the use of medically accepted birth control during trial
- grade N, M by EGD test
- subject who experience 2 day out of 1 week during recent 1 month
Key exclusion criteria (15 listed)
- subjects who can write the diary by himself, herself
- pregnant woman, breastfeeding woman
- allgeric or intolerabiliy to revaprazan or esomeprazole
- feeling of heavy stomach, distention
- surgery history in stomach or esophagus
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 |
|---|---|---|
| YH1885L(Revaprazan) | Drug | YH1885L 100mg, YH1885L 33.3 mg, YH1885L 50mg, YH1885L 66.6 mg |
| Esomeprazole 20mgAlso: Nexium | Drug | Esomeprazole 20mg |
| placebo | Drug | Esomeprazole 20mg, YH1885L 100mg, YH1885L 50mg |
Primary outcome
the rate of subject who had 'complete recovery' of symptom after 4 week administration
Time frame: 4 week
'complete recovery' means subjects never experience heartburn or acid regurgitation during last 1 week.
10 secondary outcomes
the rate of subject who had 'appropriate recovery' of symptom after 4 week administration
Time frame: 4 week
the rate of subject who had 'complete recovery' after 1 week, 2 week, 3 week IP administraion
Time frame: 3 week
the rate of subject who had 'appropriate recovery' after 1 week, 2 week, 3 week IP administraion
Time frame: 3 week
the number of night symptom-free day after IP administration
Time frame: 1 week, 2 week, 3 week, 4 week
the rate of subjects who have reduced average symptom score(more than 1) comparing to baseline score
Time frame: 1 week, 2 week, 3 week, 4 week
Evalution of Clinical Global Impression of Change
Time frame: 4 week
Evaluation of Patient Global Impression of Change
Time frame: 4 week
the change of SF-36 Survey score between baseline and completion visit
Time frame: 4 week
the change of ESS survey score among baseline, 2 week and 4 week
Time frame: 2, 4 week
Safety
Time frame: 4 week
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 10 Jul 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing YH1885L(Revaprazan) and Esomeprazole 20mg in people with Non-erosive Reflux Disease, run by Yuhan Corporation at 10 sites in South Korea.
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 6 inclusion and 15 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 10 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in South Korea. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 rate of subject who had 'complete recovery' of symptom after 4 week administration (time frame: 4 week). 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 10 Jul 2014.