Clinical trial NCT03928470: Clinical Trial to Evaluate the Efficacy and Safety of EsoDuo Tab. 20/800mg
Official title: A Multicenter, Randomized, Double-blind, Active-controlled Phase 4 Study to Evaluate the Efficacy and Safety of EsoDuo Tab. 20/800mg in Patients With Non-erosive Reflux Disease(NERD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Non-erosive Reflux Disease(NERD)
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2019-04-26
Enrollment: 379
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To Evaluate the Efficacy and Safety of EsoDuo Tab. 20/800mg

Detailed description: A multicenter, randomized, double-blind, active-controlled phase 4 study to evaluate the efficacy and safety of EsoDuo Tab. 20/800mg in patients with non-erosive reflux disease(NERD)

Eligibility criteria: Inclusion Criteria:

1. Male or Female aged ≥ 19 years
2. Episode of heartburn for 3 months or more during prior to randomization visit.
3. Episode of heartburn for 2 days or more during the last 7 days prior to randomization visit.
4. Grade N, M by EGD test.

Exclusion Criteria:

1. Surgery history on stomach or esophagus
2. Active medical history of stomach, esophagus area
3. Other system disorder which can disturb this trial
4. Patients taking the contraindication of concomitant medications
5. Clinically significant Abnormal Lab test
6. Pregnant woman, Breastfeeding woman.

Primary outcomes:
measure: Complete resolution of heartburn(HB), Last 7 days of treatment, 4 weeks.
timeFrame: 4 weeks after drug administrations.
Secondary outcomes:
measure: Complete resolution of heartburn(HB), Last 7 days of treatment, 2 weeks.
timeFrame: 2 weeks after drug administrations
measure: Complete resolution of Acid regurgitation, Last 7 days of treatment, 2 / 4 weeks.
timeFrame: 2/4 weeks after drug administrations.
measure: The percentage of Heartburn(HB) / Acid regurgitation only 1 day or less free days, 2 / 4 weeks.
timeFrame: 2/4 weeks after drug administrations.
measure: The percentage of free days without Heartburn(HB) / Acid regurgitation, 2 / 4 weeks.
timeFrame: 2/4 weeks after drug administrations.
measure: The time to the first 24/48-h, 7-d of Heartburn(HB) / Acid regurgitation free interval.
timeFrame: 2/4 weeks after drug administrations.
measure: Change from baseline in the Heartburn(HB) / Acid regurgitation Symptom score, 2 / 4 weeks.
timeFrame: 2/4 weeks after drug administrations.
measure: Heartburn(HB) / Acid regurgitation symptoms per investigator assessment, 4weeks.
timeFrame: 4 weeks after drug administrations.
measure: Time to first resolution of Heartburn(HB), Day 1
timeFrame: 1 day after drug administrations.
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
city: Busan
country: Korea, Republic of
facility: Kosin University Gospel Hospital
city: Cheonan
country: Korea, Republic of
facility: Soonchunhyang University Cheonan Hospital
city: Cheongju
country: Korea, Republic of
facility: Chungbuk National University Hospital
city: Chuncheon
country: Korea, Republic of
facility: Hallym University Chuncheon Seonsim Hospital
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medicar Center
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Goyang
country: Korea, Republic of
facility: Myongji Hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Ajou University Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Hanyang University Guri Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Inje University ilsan Paik Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Soonchunhyang University Bucheon Hospital
city: Iksan
country: Korea, Republic of
facility: Wonkwang University Hospital
city: Ilsan
country: Korea, Republic of
facility: Dongguk University IIsan Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon Gil Hospital
city: Jeju
country: Korea, Republic of
facility: Jeju National University Hospital
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University Hospital
city: Pusan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital
city: Pusan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital
city: Pusan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Pusan
country: Korea, Republic of
facility: Yangsan Pusan National University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center, Seoul
city: Seoul
country: Korea, Republic of
facility: Catholic University Seoul St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Chung Ang University Hospital
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance
city: Seoul
country: Korea, Republic of
facility: Hanyang University Hospital
city: Seoul
country: Korea, Republic of
facility: Konkuk University Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Kyunghee Universtiy Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Seoul Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Soonchunhyang University Seoul Hospital
city: Wŏnju
country: Korea, Republic of
facility: Wonju Severance Christian Hospital
Study officials:
affiliation: Hanyang University
name: Oh Young Lee, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Park SH, Lee KN, Lee OY, Choi MG, Kim JH, Sung IK, Jang JY, Park KS, Chun HJ, Kim EY, Lee JK, Jang JS, Kim GH, Hong SJ, Lee YC, Choi SC, Kim HS, Kim TO, Baik GH, Jeon YC. A Randomized, Double-Blind, Active-Control, Noninferiority, Multicenter, Phase 4 Study to Evaluate the Efficacy and Safety of Esomeprazole/Sodium Bicarbonate 20/800 mg in Patients with Nonerosive Gastroesophageal Reflux Disease. Gut Liver. 2023 Mar 15;17(2):226-233. doi: 10.5009/gnl220023. Epub 2022 Jun 22.