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

Chong Kun Dang

Status and phase: Completed; Phase 4

Conditions: Non-erosive Reflux Disease(NERD)

Treatments: Drug: EsoDuo Tab. 20/800mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT03928470

273GERD18019

Details and patient eligibility

About

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

Full 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)

Enrollment: 379 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

379 participants in 2 patient groups

EsoDuo Tab. 20/800mg

Experimental group

Description:

EsoDuo Tab. 20/800mg

Treatment:

Drug: EsoDuo Tab. 20/800mg

Nexium Tab. 20mg

Active Comparator group

Description:

Nexium Tab. 20mg

Treatment:

Drug: EsoDuo Tab. 20/800mg