Erosive Gastroesophageal Reflux DiseasePhase 3NCT04080726
Efficacy and Safety of HIP1601 Capsule
A Phase 3 study testing HIP1601 and HGP1705 in people with Erosive Gastroesophageal 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 erosive gastroesphageal reflux disease. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Erosive Gastroesophageal Reflux Disease
- What is being tested?
- HIP1601 and HGP1705
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 213 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Oct 2018to 3 Dec 2019
- 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
- Esophago-Gastro-Duodenoscopy LA classification ≥ grade A
- Patients experienced heartburn or acid regurgitation within 7 days of screening day
- Patients understood the consents and purpose of this trial and signed consent form
Who cannot join
- Has malignancy in the upper gastrointestinal tract, digestive ulcer, bleeding disorder or signs of gastrointestinal bleeding
- Has a severe liver disorder(at screening day, AST or ALT level exceeds 3 times more than normal upper range)
- Has a clinically significant renal failure(at screening day, MDRD eGFP ≤ 59 mL/min/1.73m2 or Serum creatinine >2.0mg/dL)
- Uncontrolled diabetes mellitus
- Before screening EGD, a patient who has taken H2-receptor antagonist or PPI within 2 weeks
- Before screening EGD, a patient who has taken drugs containing following list within 1 weeks : warfarin, anticholinergics for spasmolytic GI, antineoplastic agents, salicylates(except 100mg a day for prevention of cardiovascular disease), steroids, propulsives, sucralfate, NSAIDs, other antacids(e.g. antacids of prostaglandin analogs, antacids of aluminum/magnesium)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Double-blind, Phase Ⅲ Study to Compare Efficacy and Safety of HIP1601 40mg and HGP1705 40mg in Patients With Erosive Gastroesophageal Reflux Disease
The purpose of this study is to investigate the safety and clinical efficacy of HIP1601 in patients with erosive gastroesphageal reflux disease.
- Conditions
- Erosive Gastroesophageal Reflux Disease
- Being tested
- HIP1601, HGP1705, HIP1601 Placebo, HGP1705 Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIP1601Drug
Also called esomeprazole
Oral esomeprazole
HGP1705Drug
Also called Nexium Tab
Oral Nexium Tab
HIP1601 PlaceboDrug
Oral Placebo
HGP1705 PlaceboDrug
Oral Placebo
| Study group | Role | What they receive |
|---|---|---|
| HIP1601+HGP1705 Placebo | Experimental | HIP1601+HGP1705 Placebo for 4weeks. if not fully cured, take HIP1601+HGP1705 Placebo for addtional 4weeks Receives: Drug: HIP1601; Drug: HGP1705 Placebo |
| HGP1705+HIP1601 Placebo | Experimental | HGP1705+HIP1601 Placebo for 4weeks. if not fully cured, take HGP1705+HIP1601 Placebo for addtional 4weeks Receives: Drug: HGP1705; Drug: HIP1601 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete healing rate
percentage of subjects whose erosion is completely cured
Measured: at 4 weeks or 8 weeks
Secondary outcomes (7)
Complete healing rate
percentage of subjects whose erosion is completely cured
Measured: at 4 weeks
Complete resolution rate of each symptom in GERD
Measured: at 4,8 weeks
Proportion of heartburn-free days, acid regurgitation-free days
Measured: at 1, 2, 4, 8 weeks
Proportion of heartburn-free nights, acid regurgitation-free nights
Measured: at 1, 2, 4, 8 weeks
Time to sustained resolution heartburn, acid regurgitation
Measured: at 4 weeks or 8 weeks
Time to sustained resolution of nocturnal heartburn, nocturnal acid regurgitation
Measured: at 4 weeks or 8 weeks
Total number of use of relief drugs and average usage per day
Measured: at 4 weeks or 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start25 Oct 2018
- Primary completion3 Dec 2019
- Study completion3 Dec 2019
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 Erosive Gastroesophageal 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
- Model description
- multicenter, randomized, double-blind, parallel group study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hunyong Jung, MD, Ph.D., Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04080726
- Sponsor's protocol ID
- HM-ESOM-301
- Status last verified
- Nov 2020
- First submitted
- 4 Sep 2019
- Last updated
- 30 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lim H, Park JK, Chung H, Lee SH, Park JM, Park JH, Kim GH, Shin SK, Hong SJ, Lee KJ, Park MI, Jung HK, Kim HS, Sung JK, Jeon SW, Choi SC, Moon JS, Kim N, Park JJ, Hong SH, Kim NY, Jung HY. Efficacy and safety of HIP1601 (dual delayed-release esomeprazole) 40 mg in erosive esophagitis compared to HGP1705 (delayed-release esomeprazole) 40 mg: a multicenter, randomized, double-blind, non-inferiority study. BMC Gastroenterol. 2023 Dec 18;23(1):447. doi: 10.1186/s12876-023-03087-6.
PubMed 38110901
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Phase Ⅲ Study to Compare Efficacy and Safety of HIP1601 40mg and HGP1705 40mg in Patients With Erosive Gastroesophageal Reflux Disease
- ClinicalTrials.gov ID
- NCT04080726
- Acronym / sponsor ID
- HM-ESOM-301
- Conditions
- Erosive Gastroesophageal Reflux Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 25 Oct 2018 (actual)
- Primary completion
- 3 Dec 2019 (actual)
- Study completion
- 3 Dec 2019 (actual)
- First posted
- 6 Sep 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.
The purpose of this study is to investigate the safety and clinical efficacy of HIP1601 in patients with erosive gastroesphageal reflux disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- multicenter, randomized, double-blind, parallel group study
| Arm | Type | Receives |
|---|---|---|
| HIP1601+HGP1705 Placebo | Experimental | Drug: HIP1601, Drug: HGP1705 PlaceboHIP1601+HGP1705 Placebo for 4weeks. if not fully cured, take HIP1601+HGP1705 Placebo for addtional 4weeks |
| HGP1705+HIP1601 Placebo | Experimental | Drug: HGP1705, Drug: HIP1601 PlaceboHGP1705+HIP1601 Placebo for 4weeks. if not fully cured, take HGP1705+HIP1601 Placebo for addtional 4weeks |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 19≤ age ≤ 75
- Esophago-Gastro-Duodenoscopy LA classification ≥ grade A
- Patients experienced heartburn or acid regurgitation within 7 days of screening day
- Patients understood the consents and purpose of this trial and signed consent form
Key exclusion criteria (6 listed)
- Has malignancy in the upper gastrointestinal tract, digestive ulcer, bleeding disorder or signs of gastrointestinal bleeding
- Has a severe liver disorder(at screening day, AST or ALT level exceeds 3 times more than normal upper range)
- Has a clinically significant renal failure(at screening day, MDRD eGFP ≤ 59 mL/min/1.73m2 or Serum creatinine >2.0mg/dL)
- Uncontrolled diabetes mellitus
- Before screening EGD, a patient who has taken H2-receptor antagonist or PPI within 2 weeks
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 |
|---|---|---|
| HIP1601Also: esomeprazoleOral esomeprazole | Drug | HIP1601+HGP1705 Placebo |
| HGP1705Also: Nexium TabOral Nexium Tab | Drug | HGP1705+HIP1601 Placebo |
| HIP1601 PlaceboOral Placebo | Drug | HGP1705+HIP1601 Placebo |
| HGP1705 PlaceboOral Placebo | Drug | HIP1601+HGP1705 Placebo |
Primary outcome
Complete healing rate
Time frame: at 4 weeks or 8 weeks
percentage of subjects whose erosion is completely cured
7 secondary outcomes
Complete healing rate
Time frame: at 4 weeks
Complete resolution rate of each symptom in GERD
Time frame: at 4,8 weeks
Proportion of heartburn-free days, acid regurgitation-free days
Time frame: at 1, 2, 4, 8 weeks
Proportion of heartburn-free nights, acid regurgitation-free nights
Time frame: at 1, 2, 4, 8 weeks
Time to sustained resolution heartburn, acid regurgitation
Time frame: at 4 weeks or 8 weeks
Time to sustained resolution of nocturnal heartburn, nocturnal acid regurgitation
Time frame: at 4 weeks or 8 weeks
Total number of use of relief drugs and average usage per day
Time frame: at 4 weeks or 8 weeks
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 30 Nov 2020.
- Derived from this study: PubMed 38110901Lim H, Park JK, Chung H, Lee SH, Park JM, Park JH, Kim GH, Shin SK, Hong SJ, Lee KJ, Park MI, Jung HK, Kim HS, Sung JK, Jeon SW, Choi SC, Moon JS, Kim N, Park JJ, Hong SH, Kim NY, Jung HY. Efficacy and safety of HIP1601 (dual delayed-release esomeprazole) 40 mg in erosive esophagitis compared to HGP1705 (delayed-release esomeprazole) 40 mg: a multicenter, randomized, double-blind, non-inferiority study. BMC Gastroenterol. 2023 Dec 18;23(1):447. doi: 10.1186/s12876-023-03087-6.
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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.
Hunyong Jung, MD, Ph.D. principal investigator
Asan Medical Center
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 HGP1705 in people with Erosive Gastroesophageal 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 4 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 30 Nov 2020. 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?
Complete healing rate (time frame: at 4 weeks or 8 weeks). 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 NCT04080726, 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 30 Nov 2020.