A Phase 4 interventional study of Tegoprazan and Esomeprazole in Gastroesophageal Reflux Disease, sponsored by HK inno.N Corporation. Recruiting at 1 site in Korea, Republic of. Open to participants aged 19 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-08-03.
Sponsored by HK inno.N Corporation · Phase 4, Interventional, and Treatment
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Among 70 studies in Gastroesophageal Reflux with a site in Korea, Republic of — 8 open to participants now, 10 under way, none of them phase 3. Gastroesophageal Reflux · Korea, Republic of.
Among the 70 studies in Gastroesophageal Reflux with a site in Korea, Republic of, this one is the 4th largest by planned enrollment of the 52 interventional ones that give a count, is one of 5 that started in 2023, is one of 8 in phase 4, and was the 53rd registered.
1,213 studies on the registry are indexed under Gastroesophageal Reflux; 202 are open to participants now.
Browse Gastroesophageal Reflux studies →8 of the 70 studies in Gastroesophageal Reflux with a site in Korea, Republic of are open now. Recruiting first, the newest first:
HK inno.N Corporation · Sites in Korea, Republic of
Ages 19+
Incheon St.Mary's Hospital · Sites in Korea, Republic of
Ages 19+
Jeil Pharmaceutical Co., Ltd. · Sites in Korea, Republic of
Ages 19+
HK inno.N Corporation · Sites in Korea, Republic of
Ages 19+
Chong Kun Dang Pharmaceutical · Sites in Korea, Republic of
Ages 19+
A study can be open while its sites in Korea, Republic of have not opened yet or have stopped. Only those recruiting at a site in Korea, Republic of →
Of the 132 Gastroesophageal Reflux studies recruiting now, 56 (42%) set no upper age limit and 53 (40%) stop at 75 or younger; 22 take children under 18; 20 take healthy volunteers.
This study: 19 Years to 75 Years · all sexes · no healthy volunteers.
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70 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 22 · Phase 2 6 · Phase 3 11 · Phase 4 8
First in 2006; this study’s year is marked. 5 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 338 is above the median of 68 across 798 interventional studies indexed under Gastroesophageal Reflux.
Median enrollment 54 across the 52 interventional studies, 1,775 across the 18 observational. Of the 50 that completed or were terminated, 2 (4%) have results posted.
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44 of 70 have an industry lead sponsor. The 10 most frequent:
HK inno.N Corporation is the lead sponsor of 104 studies on the registry; 19 are open to participants now.
HK inno.N Corporation has 5 studies filed under Gastroesophageal Reflux — fewer than ten, so there is no comparison to draw.
1 of the studies in Gastroesophageal Reflux with a site in Korea, Republic of that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07678177HK inno.N CorporationAn Observational Study to Evaluate the Efficacy and Safety of K-CAB Tab./K-CAB ODT(Tegoprazan) in GERD Patients | 2027-06-30 |
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Among the 70 studies in Gastroesophageal Reflux with a site in Korea, Republic of, from their registry updates:
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This study aims to compare the nighttime heartburn improvement effect of Tegoprazan 50mg and Esomeprazole 40mg(or 20mg) in patients with GERD.
This is a multi-center, double-blind, randomized, active-controlled phase 4 study. Subjects will be randomly assigned to one of the two treatment groups (tegoprazan 50mg, esomeprazole 40mg or 20mg).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Tegoprazan 50mg, once daily, oral administration for two weeks
Drug: Tegoprazan
1. In case of ERD patients: Esomeprazole 40mg, qd, oral administration for two weeks 2. In case of NERD patients: Esomeprazole 20mg, qd, oral administration for two weeks
Drug: Esomeprazole
Tegoprazan 50mg tablet
Esomeprazole 20mg tablet 1. For patients with ERD: two Esomeprazole 20mg tablets 2. For patients with NERD: one Esomeprazole 20mg tablet
Percentage of days without nighttime heartburn during the 2-week dosing period
Percentage of days without nighttime heartburn = Number of days without nighttime heartburn symptoms during the dosing period / Number of days when nighttime heartburn was assessed x 100
Time frame: 2 weeks
Time to first nighttime hearturn-free interval(days)
Number of days to reach the first day without symptoms of nighttime heartburn after the administration of investigational drug
Time frame: 2 weeks
Percentage of days without daytime heartburn during the 2-week dosing period
Percentage of days without daytime heartburn = Number of days without daytime heartburn symptoms during the dosing period / Number of days when daytime heartburn was assessed x 100
Time frame: 2 weeks
Started Mar 2023 (actual). Primary completion is estimated for Dec 2024, 21 months after the start.
Of 30 phase 4 interventional studies under Gastroesophageal Reflux, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 53. This study's planned 21 months is below that.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Tegoprazan