Phase 2 Clinical Trial to Investigate the Safety, Tolerability and Efficacy of YH1885L in Patients With Non-erosive Reflux Disease(NERD)

Non-erosive Reflux Disease Clinical Trial

Official title:

Randomized, Double-blind, Active-controlled, Multi-center Phase 2 Clinical Trial to Investigate the Safety, Tolerability and Efficacy of YH1885L in Patients With Non-erosive Reflux Disease(NERD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01750437
• Other study ID #: YH1885L-201
• Status: Completed
• Phase: Phase 2
• First received: December 12, 2012
• Last updated: July 8, 2014
• Start date: January 2013
• Est. completion date: April 2014

Study information

• Verified date: July 2014
• Source: Yuhan Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Randomized, double-blind, active-controlled, multi-center phase 2 clinical trial to investigate the safety, tolerability and efficacy of YH1885L in patients with non-erosive reflux disease(NERD)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: April 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• subjects who signed written informed consent form

• more than 20 yr subject

• subjects who agree the use of medically accepted birth control during trial

• grade N, M by EGD test

• subject who experience 2 day out of 1 week during recent 1 month

• subject who experience 2 day out of 1 week during run-in period

Exclusion Criteria:

• subjects who can write the diary by himself, herself

• pregnant woman, breastfeeding woman

• allgeric or intolerabiliy to revaprazan or esomeprazole

• feeling of heavy stomach, distention

• surgery history in stomach or esophagus

• active medical history of stomach, esophagus area

• other system disorder which can disturb this trial

• Hep B, C virus, HIV carrier or patients

• past history of malignant tumor

• any psychiatric past or current history

• abnormal lab test

• abnormal ecg test

• zollinger-ellison disease

• current or past history of substance, drug abuse

• subject who should regulary takes medication which can disturb this trial

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Non-erosive Reflux Disease

Intervention

Drug:
• YH1885L(Revaprazan)

• Esomeprazole 20mg

• placebo

Locations

Country	Name	City	State
Korea, Republic of	DongA university hospital	Busan
Korea, Republic of	Kyungbook University hospital	Daegu
Korea, Republic of	Chungnam university hospital	Daejeon
Korea, Republic of	Catholic Incheon hospital	Incheon
Korea, Republic of	Jeonbuk University hospital	Jeonju
Korea, Republic of	Asan hospital	Seoul
Korea, Republic of	Catholic yeouido sungmo hospital	Seoul
Korea, Republic of	Konkuk unversity hospital	Seoul
Korea, Republic of	Kyunghee university hospital	Seoul
Korea, Republic of	Seoul university hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yuhan Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Comparison of H.pylori(+),(-) subjects about primay and seconday outcome		4 week	No
Primary	the rate of subject who had 'complete recovery' of symptom after 4 week administration	'complete recovery' means subjects never experience heartburn or acid regurgitation during last 1 week.	4 week	No
Secondary	the rate of subject who had 'appropriate recovery' of symptom after 4 week administration	'Appropriate recovery' means subjects experience heartburn or acid regurgitation only 1 or less during last 1 week.	4 week	No
Secondary	the rate of subject who had 'complete recovery' after 1 week, 2 week, 3 week IP administraion		3 week	No
Secondary	the rate of subject who had 'appropriate recovery' after 1 week, 2 week, 3 week IP administraion		3 week	No
Secondary	the number of night symptom-free day after IP administration	Symptoms means "Heartburn or Acid regurgitation"	1 week, 2 week, 3 week, 4 week	No
Secondary	the rate of subjects who have reduced average symptom score(more than 1) comparing to baseline score		1 week, 2 week, 3 week, 4 week	No
Secondary	Evalution of Clinical Global Impression of Change		4 week	No
Secondary	Evaluation of Patient Global Impression of Change		4 week	No
Secondary	the change of SF-36 Survey score between baseline and completion visit		4 week	No
Secondary	the change of ESS survey score among baseline, 2 week and 4 week	ESS stands for Epworth sleepiness scale.	2, 4 week	No
Secondary	Safety	AE, Physical exam, 12-lead ECG, Vital signs, laboratory test	4 week	Yes