Clinical Trial to Evaluate the Efficacy and Safety of EsoDuo Tab. 20/800mg

• Sponsor: Chong Kun Dang Pharmaceutical (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03928470
• Collaborator: (none)
• Enrollment: 379
• Locations: 38
• Arms: 2
• Actual Duration (Months): 10.7
• Patients Per Site: 10
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Non-erosive Reflux Disease(NERD)	Drug: EsoDuo Tab. 20/800mg	Phase 4

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)

Study Design

• Study Type: Interventional
• Actual Enrollment: 379 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: Jan 29, 2019
• Actual Primary Completion Date: Dec 20, 2019
• Actual Study Completion Date: Dec 20, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: EsoDuo Tab. 20/800mg EsoDuo Tab. 20/800mg	Drug: EsoDuo Tab. 20/800mg; Nexium Tab. 20mg
Active Comparator: Nexium Tab. 20mg Nexium Tab. 20mg	Drug: EsoDuo Tab. 20/800mg; Nexium Tab. 20mg

Outcome Measures

Primary Outcome Measures

1. Complete resolution of heartburn(HB), Last 7 days of treatment, 4 weeks. [4 weeks after drug administrations.]

   Compare Experimental group with Active Comparator.

Secondary Outcome Measures

1. Complete resolution of heartburn(HB), Last 7 days of treatment, 2 weeks. [2 weeks after drug administrations]

   Compare Experimental group with Active Comparator.

2. Complete resolution of Acid regurgitation, Last 7 days of treatment, 2 / 4 weeks. [2/4 weeks after drug administrations.]

   Compare Experimental group with Active Comparator.

3. The percentage of Heartburn(HB) / Acid regurgitation only 1 day or less free days, 2 / 4 weeks. [2/4 weeks after drug administrations.]

   Compare Experimental group with Active Comparator.

4. The percentage of free days without Heartburn(HB) / Acid regurgitation, 2 / 4 weeks. [2/4 weeks after drug administrations.]

   Compare Experimental group with Active Comparator.

5. The time to the first 24/48-h, 7-d of Heartburn(HB) / Acid regurgitation free interval. [2/4 weeks after drug administrations.]

   Compare Experimental group with Active Comparator.

6. Change from baseline in the Heartburn(HB) / Acid regurgitation Symptom score, 2 / 4 weeks. [2/4 weeks after drug administrations.]

   Compare Experimental group with Active Comparator.

7. Heartburn(HB) / Acid regurgitation symptoms per investigator assessment, 4weeks. [4 weeks after drug administrations.]

   Compare Experimental group with Active Comparator.

8. Time to first resolution of Heartburn(HB), Day 1 [1 day after drug administrations.]

   Compare Experimental group with Active Comparator.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dong-A University Hospital	Busan		Korea, Republic of
2	Kosin University Gospel Hospital	Busan		Korea, Republic of
3	Soonchunhyang University Cheonan Hospital	Cheonan		Korea, Republic of
4	Chungbuk National University Hospital	Cheongju		Korea, Republic of
5	Hallym University Chuncheon Seonsim Hospital	Chuncheon		Korea, Republic of
6	Daegu Catholic Hospital	Daegu		Korea, Republic of
7	Keimyung University Dongsan Medical Center	Daegu		Korea, Republic of
8	Yeungnam University Medicar Center	Daegu		Korea, Republic of
9	Chungnam National University Hospital	Daejeon		Korea, Republic of
10	Myongji Hospital	Goyang		Korea, Republic of
11	Chonnam National University Hospital	Gwangju		Korea, Republic of
12	Ajou University Hospital	Gyeonggi-do		Korea, Republic of
13	Hanyang University Guri Hospital	Gyeonggi-do		Korea, Republic of
14	Inje University ilsan Paik Hospital	Gyeonggi-do		Korea, Republic of
15	Soonchunhyang University Bucheon Hospital	Gyeonggi-do		Korea, Republic of
16	Wonkwang University Hospital	Iksan		Korea, Republic of
17	Dongguk University IIsan Hospital	Ilsan		Korea, Republic of
18	Gachon Gil Hospital	Incheon		Korea, Republic of
19	Jeju National University Hospital	Jeju		Korea, Republic of
20	Chonbuk National University Hospital	Jeonju		Korea, Republic of
21	Inje University Busan Paik Hospital	Pusan		Korea, Republic of
22	Inje University Haeundae Paik Hospital	Pusan		Korea, Republic of
23	Pusan National University Hospital	Pusan		Korea, Republic of
24	Yangsan Pusan National University Hospital	Pusan		Korea, Republic of
25	Asan Medical Center, Seoul	Seoul		Korea, Republic of
26	Catholic University Seoul St. Mary's Hospital	Seoul		Korea, Republic of
27	Chung Ang University Hospital	Seoul		Korea, Republic of
28	Gangnam Severance	Seoul		Korea, Republic of
29	Hanyang University Hospital	Seoul		Korea, Republic of
30	Konkuk University Hospital	Seoul		Korea, Republic of
31	Korea University Anam Hospital	Seoul		Korea, Republic of
32	Korea University Guro Hospital	Seoul		Korea, Republic of
33	Kyunghee Universtiy Hospital	Seoul		Korea, Republic of
34	Samsung Seoul Hospital	Seoul		Korea, Republic of
35	Seoul National University Hospital	Seoul		Korea, Republic of
36	Severance Hospital	Seoul		Korea, Republic of
37	Soonchunhyang University Seoul Hospital	Seoul		Korea, Republic of
38	Wonju Severance Christian Hospital	Wŏnju		Korea, Republic of

Sponsors and Collaborators

• Chong Kun Dang Pharmaceutical

Investigators

• Principal Investigator: Oh Young Lee, M.D., Ph.D., Hanyang University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chong Kun Dang Pharmaceutical
• ClinicalTrials.gov Identifier: NCT03928470
• Other Study ID Numbers: 273GERD18019
• First Posted: Apr 26, 2019
• Last Update Posted: Dec 24, 2019
• Last Verified: Dec 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Gastroesophageal Reflux

Study Results

No Results Posted as of Dec 24, 2019