Erosive EsophagitisPhase 3NCT03943992
Clinical Trial to Assess the Efficacy and Safety of YYD601 in the Treatment of Esophageal Reflux Disease (ERD)
A Phase 3 study testing YYD601 40mg and Nexium 40mg in people with Erosive Esophagitis, run by Yooyoung Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial summary
A randomized, double-blind, double-dummy, active comparator, multi-centers, non-inferiority design clinical trial to assess the efficacy and safety of YYD601 in ERD patients (phase 3). Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Erosive Esophagitis
- What is being tested?
- YYD601 40mg and Nexium 40mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 170 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 Jan 2019to 1 Jul 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 experienced symptom (heartburn and acid regurgitation) within 7 days before Visit 1, meet below 1) or 2) criteria, who has been made diagnosis as Erosive esophagitis(LA grade A~D) measured through the endoscopy which is carried out within (-2W±D2)
- Symptom (heartburn and acid regurgitation) is confirmed by RDQ.
- Experienced above 2 days in 1 week, Heartburn of acid regurgitation above the weakness.
- Experienced above 1 day in 1 week, Heartburn of acid regurgitation above the middle.
- 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 NERD
- Who get a diagnosis as a IBS within the last 3 months.
- Who have taken gastric acid secretion inhibitors including PPIs within 2 weeks before the endoscopy.
- 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 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 clinically significant abnormal result of ECG.
- Abnormal result of Major arrhythmia, Multifocal PVS, 2 AV-blcok etc.
- Who has the Schatzki near the LES(lower esophageal sphincter) except the Barret's esophagus.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Double-dummy, Active Comparator, Multi-centers, Non-inferiority Design Clinical Trial to Assess the Efficacy and Safety of YYD601 in the Treatment of Esophageal Reflux Disease (ERD) (Phase3).
A randomized, double-blind, double-dummy, active comparator, multi-centers, non-inferiority design clinical trial to assess the efficacy and safety of YYD601 in ERD patients (phase 3).
Read the detailed description
This phase 3 clinical trial is designed as randomized, active-comparator, double-dummy, multi-center for ERD patients, who take YYD601 40mg or Nexium 40mg for 8 weeks. Each part is assessed by 'LA grade' measured through the endoscopy, target goal is to confirm the non-inferiority of YYD601 40mg to Nexium 40mg.
- Conditions
- Erosive Esophagitis
- Being tested
- YYD601 40mg, Nexium 40mg, Placebos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YYD601 40mgDrug
Patients should take druges 30 minutes before breakfast.
Nexium 40mgDrug
Patients should take druges 30 minutes 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 40mg | Experimental | Esomeprazole magnesium Dihydrate. Receives: Drug: YYD601 40mg; Drug: Placebos |
| Nexium 40mg | Active comparator | Esomeprazole magnesium trihydrate, a substituted benzimidazole. Receives: Drug: Nexium 40mg; Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
LA grade 0(zero)
Percentage of patients(%) who's erosive esophagitis has been recovered to LA grade 0(zero) within week 8.
Calculation of the sample size was based on a margin of non-inferiority by Normal approximation.
Measured: within 8 weeks
Secondary outcomes (5)
LA grade 0(zero)
Percentage of patients(%) who's erosive esophagitis has been recovered to LA grade 0(zero) by Normal approximation and Fisher's exact test.
Measured: at 4 weeks
Frequency variation of the Heartburn and acid regurgitation by RDQ(questionnaire).
Change in frequency of the symptom(heartburn and acid regurgitation) by Shapiro-Wilk test and Wilcoxon's rank sum test.
Measured: at week 4 and 8 from baseline
Frequency variation of the Heartburn in daytime by patients diary
Percentage of patients(%) who have the symptom(heartburn and acid regurgitation) by Chi-square test and Fisher's exact test.
Measured: at 4 week and 8 week from baseline
Frequency variation of the Heartburn in nighttime by patients diary
Percentage of patients(%) who have the symptom(heartburn and acid regurgitation) by Chi-square test and Fisher's exact test.
Measured: at 4 week and 8 week from baseline
Days percentage(%) of no symptoms about the Heartburn and acid regurgitation
Patients who have experienced the heartburn and acid regurgitation in nighttime by patients diary.
Measured: at week 4 and 8 from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2019
- Study start29 Jan 2019
- Primary completion31 Jan 2020
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erosive EsophagitisStudies 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
- NCT03943992
- Sponsor's protocol ID
- YYPCT_YYD601_P3
- Status last verified
- May 2021
- First submitted
- 25 Mar 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, Double-dummy, Active Comparator, Multi-centers, Non-inferiority Design Clinical Trial to Assess the Efficacy and Safety of YYD601 in the Treatment of Esophageal Reflux Disease (ERD) (Phase3).
- ClinicalTrials.gov ID
- NCT03943992
- Acronym / sponsor ID
- YYPCT_YYD601_P3
- Conditions
- Erosive Esophagitis
- 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
- 29 Jan 2019 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 9 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.
A randomized, double-blind, double-dummy, active comparator, multi-centers, non-inferiority design clinical trial to assess the efficacy and safety of YYD601 in ERD patients (phase 3).
Detailed description
This phase 3 clinical trial is designed as randomized, active-comparator, double-dummy, multi-center for ERD patients, who take YYD601 40mg or Nexium 40mg for 8 weeks. Each part is assessed by 'LA grade' measured through the endoscopy, target goal is to confirm the non-inferiority of YYD601 40mg to Nexium 40mg.
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 40mg | Experimental | Drug: YYD601 40mg, Drug: PlacebosEsomeprazole magnesium Dihydrate. |
| Nexium 40mg | Active comparator | Drug: Nexium 40mg, 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 (6 listed)
- A man or woman over 20 years old less than 70 years old.
- A man or woman who has experienced symptom (heartburn and acid regurgitation) within 7 days before Visit 1, meet below 1) or 2) criteria, who has been made diagnosis as Erosive esophagitis(LA grade A~D) measured through the endoscopy which is carried out within (-2W±D2)
- 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 NERD
- Who get a diagnosis as a IBS within the last 3 months.
- Who have taken gastric acid secretion inhibitors including PPIs within 2 weeks before the endoscopy.
- 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.)
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 40mgPatients should take druges 30 minutes before breakfast. | Drug | YYD601 40mg |
| Nexium 40mgPatients should take druges 30 minutes before breakfast. | Drug | Nexium 40mg |
| 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 40mg, YYD601 40mg |
Primary outcome
LA grade 0(zero)
Time frame: within 8 weeks
Percentage of patients(%) who's erosive esophagitis has been recovered to LA grade 0(zero) within week 8. Calculation of the sample size was based on a margin of non-inferiority by Normal approximation.
5 secondary outcomes
LA grade 0(zero)
Time frame: at 4 weeks
Frequency variation of the Heartburn and acid regurgitation by RDQ(questionnaire).
Time frame: at week 4 and 8 from baseline
Frequency variation of the Heartburn in daytime by patients diary
Time frame: at 4 week and 8 week from baseline
Frequency variation of the Heartburn in nighttime by patients diary
Time frame: at 4 week and 8 week from baseline
Days percentage(%) of no symptoms about the Heartburn and acid regurgitation
Time frame: at week 4 and 8 from 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 40mg and Nexium 40mg in people with Erosive Esophagitis, 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 6 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?
LA grade 0(zero) (time frame: within 8 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 11 May 2021.