Skip to main content
OpenTrials
Completed

NCT Number: NCT01750437

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

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)

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Non-erosive Reflux Disease Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Catholic yeouido sungmo hospital, Seoul, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

YH1885L(Revaprazan)

Drug

Esomeprazole 20mg

Drug

Other names: Nexium

Placebo

Drug

Primary outcomes

  1. the rate of subject who had 'complete recovery' of symptom after 4 week administration

    Time frame: 4 week

    'complete recovery' means subjects never experience heartburn or acid regurgitation during last 1 week.

Secondary outcomes

  1. the rate of subject who had 'appropriate recovery' of symptom after 4 week administration

    Time frame: 4 week

    'Appropriate recovery' means subjects experience heartburn or acid regurgitation only 1 or less during last 1 week.

  2. the rate of subject who had 'complete recovery' after 1 week, 2 week, 3 week IP administraion

    Time frame: 3 week

  3. the rate of subject who had 'appropriate recovery' after 1 week, 2 week, 3 week IP administraion

    Time frame: 3 week

  4. the number of night symptom-free day after IP administration

    Time frame: 1 week, 2 week, 3 week, 4 week

    Symptoms means "Heartburn or Acid regurgitation"

  5. the rate of subjects who have reduced average symptom score(more than 1) comparing to baseline score

    Time frame: 1 week, 2 week, 3 week, 4 week

  6. Evalution of Clinical Global Impression of Change

    Time frame: 4 week

  7. Evaluation of Patient Global Impression of Change

    Time frame: 4 week

  8. the change of SF-36 Survey score between baseline and completion visit

    Time frame: 4 week

  9. the change of ESS survey score among baseline, 2 week and 4 week

    Time frame: 2, 4 week

    ESS stands for Epworth sleepiness scale.

  10. Safety

    Time frame: 4 week

    AE, Physical exam, 12-lead ECG, Vital signs, laboratory test

Other outcomes

  1. Comparison of H.pylori(+),(-) subjects about primay and seconday outcome

    Time frame: 4 week

Sponsors and collaborators

Lead sponsor

Yuhan Corporation

Industry

Registry information

Official study 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)

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Dec 17, 2012
Registry last updated
Jul 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.