Non-erosive Reflux DiseasePhase 3NCT03967886
Clinical Trial to Assess the Efficacy and Safety of YYD601 in NERD Patients
A Phase 3 study testing YYD601 20mg and Nexium 20mg in people with Non-erosive Reflux Disease, run by Yooyoung Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial summary
Clinical Trial to Assess the Efficacy and Safety of YYD601 in NERD Patients Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Non-erosive Reflux Disease
- What is being tested?
- YYD601 20mg and Nexium 20mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 170 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Apr 2019to 27 May 2020
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A man or woman over 20 years old less than 70 years old.
- A man or woman who has below all characters and diagnosis as NERD.
- A man or woman who has experienced symptom(hearburn or/and acid regurgitation) over 3month at least.
- A man or woman who has experienced symptom(heartburn or/and acid regurgitation) within 7days before Visit1, meet below 1) or 2) criteria.
- Symptom (heartburn and acid regurgitation) is confirmed by RDQ
- Experienced above 2 days in a week, heartburn of acid regurgitation above the weakness.
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- Experienced above 1 day in a week, heartburn of acid regurgitation above the middle.
- A man or woman who has been made diagnosis as LA grade0(Zero) measured through the dendoscopy which is corried out within 14 days, there is no observed muscosal break.
- A man or woman who has a full understanding of this clinical trial through the detailed explanation, agree in writing to participate in this trial.
Who cannot join
- Who has hyper sensitivity reaction about other drugs, ingredients, components of investigator product or compound of benzimidazole.
- Who has ERD.
- Who get a diagnosis as a IBS within the last 3 months.
- Who have taken drugs about reflux esophagitis (H₂-receptor inhibitor (H2RA) Prostaglandin(PG), Antacid, Prokinetic acid etc.) above 2 times as an usual dose. (* refer to the Concomitant medication in text.)
- Who havbe taken gastric acid secretion inhibitors including PPIs within 2 weeks before the endoscopy.
- Who has been experienced the disease affecting the esophagus(Eosinophilic esophagitis, esophageal varices, cirrhosis, Virus or Fungal infection, Esophageal stricture, primary esophageal motility disorder and gastrointestinal bleeding). Or who has a history of radio therapeutics, freeze treatment about the esophagus.
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- Who has the gastric or duodenal ulcer, Zollinger-Ellison and other acid hypersecretory condition been experienced.
- Who has hyper-sensitivity, reaction about PPIs (ex. Lansoprazole, omeprazole, rabeprazole, pantoprazole or esomeprazole).
- Who has gotten a diagnosis as a cancer within 5 years before participated in this clinical trail (expect the basal cell on the skin), peptic ulcer or benign tumor.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multi-centers Clinical Trial to Assess the Efficacy and Safety of YYD601 in NERD Patients (Phase3).
Clinical Trial to Assess the Efficacy and Safety of YYD601 in NERD Patients
Read the detailed description
This Phase 3 Clinical Trial is Designed as Randomized, Double-blind, Placebo-controlled, Multi-centers Clinical Trial to Assess the Efficacy and Safety of YYD601 in NERD Patients (Phase3).
- Conditions
- Non-erosive Reflux Disease
- Being tested
- YYD601 20mg, Nexium 20mg, Placebos
- 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.
YYD601 20mgDrug
Patients should take drugs an hour before breakfast.
Nexium 20mgDrug
Patients should take drugs an hour before breakfast.
PlacebosDrug
The placebo YYD601 is made from microcrystalline cellulose covered with hard shell. The placebo Nexium is made from microcrystalline cellulose, Crospovidone, Magnesiumstearat and other ingredients.
| Study group | Role | What they receive |
|---|---|---|
| YYD601 20mg | Experimental | Esomeprazole magnesium Dihydrate. Receives: Drug: YYD601 20mg; Drug: Placebos |
| Nexium 20mg | Active comparator | Esomeprazole magnesium trihydrate, a substituted benzimidazole. Receives: Drug: Nexium 20mg; Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovered percentage(%) of the symptom
Recovered percentage(%) of the symptom(heartburn or/and acid regurgitation) measured by RDQ after administration(baseline).
Measured: within 4 weeks
Change of the score about the symptom
Change of the score about the symptom(heartburn or/and acid regurgitation) measured by RDQ after administration(baseline).
Measured: within 4 weeks
Percentage(%) of the patients who have symptom during the daytime
Percentage(%) of the patients who have symptom(heartburn or/and acid regurgitation) during the daytime measured by Patients diary after administration(baseline).
Measured: within 4 weeks
Percentage(%) of the patients who have symptom during the nighttime
Percentage(%) of the patients who have symptom(heartburn or/and acid regurgitation) during the nighttime measured by Patients diary after administration(baseline).
Measured: within 4 weeks
Percentage(%) of the days no symtom
Percentage(%) of the days no symptom(heartburn or/and acid regurgitation) among the patients who have symptom(heartburn or/and acid regurgitation) during the nighttime measured by Patients diary after administration(baseline).
Measured: within 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start10 Apr 2019
- Primary completion20 Dec 2019
- Study completion27 May 2020
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.
- 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
- Who is masked
- Participant, Care provider
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yooyoung Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03967886
- Sponsor's protocol ID
- YYPCT_YYD601_P3(2)
- Status last verified
- May 2021
- First submitted
- 27 May 2019
- Last updated
- 11 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multi-centers Clinical Trial to Assess the Efficacy and Safety of YYD601 in NERD Patients (Phase3).
- ClinicalTrials.gov ID
- NCT03967886
- Acronym / sponsor ID
- YYPCT_YYD601_P3(2)
- Conditions
- Non-erosive Reflux Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Yooyoung Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Apr 2019 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 27 May 2020 (actual)
- First posted
- 30 May 2019 (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.
Clinical Trial to Assess the Efficacy and Safety of YYD601 in NERD Patients
Detailed description
This Phase 3 Clinical Trial is Designed as Randomized, Double-blind, Placebo-controlled, Multi-centers Clinical Trial to Assess the Efficacy and Safety of YYD601 in NERD Patients (Phase3).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| YYD601 20mg | Experimental | Drug: YYD601 20mg, Drug: PlacebosEsomeprazole magnesium Dihydrate. |
| Nexium 20mg | Active comparator | Drug: Nexium 20mg, Drug: PlacebosEsomeprazole magnesium trihydrate, a substituted benzimidazole. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- A man or woman over 20 years old less than 70 years old.
- A man or woman who has below all characters and diagnosis as NERD.
- Symptom (heartburn and acid regurgitation) is confirmed by RDQ
- A man or woman who has a full understanding of this clinical trial through the detailed explanation, agree in writing to participate in this trial.
Key exclusion criteria (9 listed)
- Who has hyper sensitivity reaction about other drugs, ingredients, components of investigator product or compound of benzimidazole.
- Who has ERD.
- Who get a diagnosis as a IBS within the last 3 months.
- Who have taken drugs about reflux esophagitis (H₂-receptor inhibitor (H2RA) Prostaglandin(PG), Antacid, Prokinetic acid etc.) above 2 times as an usual dose. (* refer to the Concomitant medication in text.)
- Who havbe taken gastric acid secretion inhibitors including PPIs within 2 weeks before the endoscopy.
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 |
|---|---|---|
| YYD601 20mgPatients should take drugs an hour before breakfast. | Drug | YYD601 20mg |
| Nexium 20mgPatients should take drugs an hour before breakfast. | Drug | Nexium 20mg |
| PlacebosThe placebo YYD601 is made from microcrystalline cellulose covered with hard shell. The placebo Nexium is made from microcrystalline cellulose, Crospovidone, Magnesiumstearat and other ingredients. | Drug | Nexium 20mg, YYD601 20mg |
Primary outcome
Recovered percentage(%) of the symptom
Time frame: within 4 weeks
Recovered percentage(%) of the symptom(heartburn or/and acid regurgitation) measured by RDQ after administration(baseline).
Change of the score about the symptom
Time frame: within 4 weeks
Change of the score about the symptom(heartburn or/and acid regurgitation) measured by RDQ after administration(baseline).
Percentage(%) of the patients who have symptom during the daytime
Time frame: within 4 weeks
Percentage(%) of the patients who have symptom(heartburn or/and acid regurgitation) during the daytime measured by Patients diary after administration(baseline).
Percentage(%) of the patients who have symptom during the nighttime
Time frame: within 4 weeks
Percentage(%) of the patients who have symptom(heartburn or/and acid regurgitation) during the nighttime measured by Patients diary after administration(baseline).
Percentage(%) of the days no symtom
Time frame: within 4 weeks
Percentage(%) of the days no symptom(heartburn or/and acid regurgitation) among the patients who have symptom(heartburn or/and acid regurgitation) during the nighttime measured by Patients diary after administration(baseline).
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 11 May 2021.
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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.
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 YYD601 20mg and Nexium 20mg in people with Non-erosive Reflux Disease, run by Yooyoung Pharmaceutical Co., Ltd. at 1 site 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 9 inclusion and 9 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 11 May 2021. 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 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 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?
Recovered percentage(%) of the symptom (time frame: within 4 weeks). The study lists 5 primary outcomes in all. 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 11 May 2021.