Non-erosive Gastroesphageal Reflux DiseasePhase 3NCT04325620
Safety to Evaluate the Efficacy and Safety of HIP1601 in Patients With Non Erosive Reflux Disease
A Phase 3 study testing HIP1601 and HGP1805 in people with Non-erosive Gastroesphageal Reflux Disease, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.
Trial summary
The purpose of this study is to investigate the safety and clinical efficacy of HIP1601 in patients with Non-erosive gastroesphageal reflux disease. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Non-erosive Gastroesphageal Reflux Disease
- What is being tested?
- HIP1601 and HGP1805
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 208 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Jun 2019to 3 Aug 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 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 19≤ age ≤ 75
- Patients who were not observed mucosal break('not present') according to the LA classification(LA grade) on the EGDEsophago-Gastro-Duodenoscopy
- Patients who had experienced major symptom within 3 months Patients experienced heartburn or acid regurgitation within 7 days of screening day
- Patients who had experienced major symptom within 7 days before randomization. Entry into study also required that patients had experienced at least mild symptoms on at least 2 days/week or at least moderate symptoms on at least 1 day/week based on RDQ
- Patients understood the consents and purpose of this trial and signed consent form
Who cannot join
- Patients who have erosive GERD, Barrett's esophagus(other significant dysplasia of esophagus), gastroesophageal varicose veins, active peptic ulcer, gastrointestinal bleeding or malignant GI tumor confirmed by endoscopy
- Patients who have a history of gastric or gastroesophageal surgery
- Patients who have Zollinger-Ellison syndrome, eosinophilic esophagitis, primary esophageal motility disorder, acute upper gastrointestinal bleeding, Functional dyspepsia, IBS, IBD within 3 months before Visit 1
- Patients with clinically significant liver, kidney, nervous system, respiratory, endocrine, hematologic, cardiovascular, urinary system disease.
- Patients Has a severe liver disorder(AST or ALT level exceeds 3 times more than normal upper range at Visit 1)
- Has a clinically significant renal failure(MDRD eGFR ≤ 59 mL/min/1.73m2 or Serum creatinine >2.0mg/dL at Visit 1)
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
About this study
Official title: A Multicenter, Randomized, Parallel, Double-Blinded, Placebo-controlled Phase 3 Study to Compare Efficacy and Safety of HIP1601 in Patients With Non-Erosive Gastroesophageal Reflux Disease(NERD)
The purpose of this study is to investigate the safety and clinical efficacy of HIP1601 in patients with Non-erosive gastroesphageal reflux disease.
Read the detailed description
A Multicenter, Randomized, Parallel, Double-Blinded, Placebo-controlled Phase Ⅲ Study to Compare Efficacy and Safety of HIP1601 in Patients with Non-Erosive Gastroesophageal Reflux Disease(NERD)
- Being tested
- HIP1601, HGP1805
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIP1601Drug
HIP1601
HGP1805Drug
Placebo of HIP1601
| Study group | Role | What they receive |
|---|---|---|
| HIP1601 Amg | Experimental | The participants will receive tretment of HIP1601 Amg, orally, once daily for 4weeks. Receives: Drug: HIP1601 |
| HGP1805 | Placebo comparator | The participants will receive tretment of HGP1805(Placebo of HIP1601), orally, once daily for 4weeks. Receives: Drug: HGP1805 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with complete resolution of major symptoms at 4-week
Complete resolution is defined as no episodes of symptom during the last 7 days of treatment.
Measured: 4 week
Secondary outcomes (7)
Percentage of patients with complete resolution of major symptoms at 2-week
Complete resolution is defined as no episodes of symptom during the last 7 days of treatment
Measured: 2 week
Frequency and Severity of Reflux disease symptom assessment using Reflux Disease Questionnaire(RDQ)
RDQ frequncy and severity score is 0 to 5 point scale, high score mean a worse outcome.
Measured: 2, 4 week
Time to complete resolution of major symptoms
defined as time to the first day of complete resolution
Measured: 4 week
Resolution rate of major symptoms of first 7 days
defined as first of 7 days with no episodes of symptom using subject's diary
Measured: 1 week
Major symptoms-Free days
Major symptoms-Free days mean rate of days that symtom's severity score is '0' using subject's diary
Measured: 1, 4 week
Quality of Life assessment using Patient Assessment of upper Gastrointestinal disorders-Quality of Life(PAGI-QoL)
PAGI-QoL total score is 0 to 30 point scale, high score mean a better outcome.
Measured: 4 week
Proportion of rescue medication amounts
Use of rescue medication
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 posted27 Mar 2020
- Study start10 Jun 2019
- Primary completion3 Aug 2020
- Study completion3 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-erosive Gastroesphageal Reflux DiseaseStudies of the same condition, open and under way.
- More trials run by Hanmi Pharmaceutical Company LimitedThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04325620
- Sponsor's protocol ID
- HM-ESOM-302
- Status last verified
- Nov 2022
- First submitted
- 26 Mar 2020
- Last updated
- 9 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Parallel, Double-Blinded, Placebo-controlled Phase 3 Study to Compare Efficacy and Safety of HIP1601 in Patients With Non-Erosive Gastroesophageal Reflux Disease(NERD)
- ClinicalTrials.gov ID
- NCT04325620
- Acronym / sponsor ID
- HM-ESOM-302
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 10 Jun 2019 (actual)
- Primary completion
- 3 Aug 2020 (actual)
- Study completion
- 3 Aug 2020 (actual)
- First posted
- 27 Mar 2020 (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.
The purpose of this study is to investigate the safety and clinical efficacy of HIP1601 in patients with Non-erosive gastroesphageal reflux disease.
Detailed description
A Multicenter, Randomized, Parallel, Double-Blinded, Placebo-controlled Phase Ⅲ Study to Compare Efficacy and Safety of HIP1601 in Patients with Non-Erosive Gastroesophageal Reflux Disease(NERD)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIP1601 Amg | Experimental | Drug: HIP1601The participants will receive tretment of HIP1601 Amg, orally, once daily for 4weeks. |
| HGP1805 | Placebo comparator | Drug: HGP1805The participants will receive tretment of HGP1805(Placebo of HIP1601), orally, once daily for 4weeks. |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 19≤ age ≤ 75
- Patients who were not observed mucosal break('not present') according to the LA classification(LA grade) on the EGDEsophago-Gastro-Duodenoscopy
- Patients who had experienced major symptom within 3 months Patients experienced heartburn or acid regurgitation within 7 days of screening day
- Patients who had experienced major symptom within 7 days before randomization. Entry into study also required that patients had experienced at least mild symptoms on at least 2 days/week or at least moderate symptoms on at least 1 day/week based on RDQ
- Patients understood the consents and purpose of this trial and signed consent form
Key exclusion criteria (6 listed)
- Patients who have erosive GERD, Barrett's esophagus(other significant dysplasia of esophagus), gastroesophageal varicose veins, active peptic ulcer, gastrointestinal bleeding or malignant GI tumor confirmed by endoscopy
- Patients who have a history of gastric or gastroesophageal surgery
- Patients who have Zollinger-Ellison syndrome, eosinophilic esophagitis, primary esophageal motility disorder, acute upper gastrointestinal bleeding, Functional dyspepsia, IBS, IBD within 3 months before Visit 1
- Patients with clinically significant liver, kidney, nervous system, respiratory, endocrine, hematologic, cardiovascular, urinary system disease.
- Patients Has a severe liver disorder(AST or ALT level exceeds 3 times more than normal upper range at Visit 1)
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 |
|---|---|---|
| HIP1601HIP1601 | Drug | HIP1601 Amg |
| HGP1805Placebo of HIP1601 | Drug | HGP1805 |
Primary outcome
Percentage of patients with complete resolution of major symptoms at 4-week
Time frame: 4 week
Complete resolution is defined as no episodes of symptom during the last 7 days of treatment.
7 secondary outcomes
Percentage of patients with complete resolution of major symptoms at 2-week
Time frame: 2 week
Frequency and Severity of Reflux disease symptom assessment using Reflux Disease Questionnaire(RDQ)
Time frame: 2, 4 week
Time to complete resolution of major symptoms
Time frame: 4 week
Resolution rate of major symptoms of first 7 days
Time frame: 1 week
Major symptoms-Free days
Time frame: 1, 4 week
Quality of Life assessment using Patient Assessment of upper Gastrointestinal disorders-Quality of Life(PAGI-QoL)
Time frame: 4 week
Proportion of rescue medication amounts
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 9 Nov 2022.
- Individual participant dataSharing planned: No
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 HIP1601 and HGP1805 in people with Non-erosive Gastroesphageal Reflux Disease, run by Hanmi Pharmaceutical Company Limited 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 5 inclusion and 6 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 9 Nov 2022. 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. Some participants in this study may receive a placebo. 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?
Percentage of patients with complete resolution of major symptoms at 4-week (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 9 Nov 2022.