S-pantoprazole 10mg Phase III Clinical Study

Last updated: October 24, 2014
Sponsor: Ahn-Gook Pharmaceuticals Co.,Ltd
Overall Status: Trial Status Unknown

Phase

3

Condition

Gastroesophageal Reflux Disease (Gerd)

Esophageal Disorders

Heartburn (Pediatric)

Treatment

N/A

Clinical Study ID

NCT02274961
LTP10_KR_1301
  • Ages 19-75
  • All Genders

Study Summary

This clinical study hypothesized that S-pantoprazole 10mg would be effective to treat Non erosive Reflux Disease than placebo.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adults between the ages of 19 and 75 inclusive

  • Patient with a history of heartburn or acid regurgitation for at least 3 months.

  • Those with episodes of heartburn for 2 days or more during the last 7 days prior tobaseline

  • Patients negative for erosive esophagitis confirmed by esophagogastroduodenoscopy(EGD)performed within 7 days of screening

  • Capable of providing written informed consent, willing and able to a comply with allprocedures of the study

Exclusion

Exclusion Criteria:

  • History of endoscopic erosive esophagitis(EE) at screening EGD.

  • Historical evidence of the following disease/conditions : symptom of Irritable bowelsyndrome

  • More tha 3cm endoscopic Barrett's esophagus or significant dysplastic changes in theesophagus

  • Proton Pump Inhibitor(PPI) within 4 weeks prior to the baseline visit

  • H2-receptor antagonist, sucralfate, prokinetics, Non Steroidal AntiinflammatoryDrugs(NSAIDs) (except low dose aspirin) during the 2 weeks prior to the screening

  • Historical evidence of the following disease/conditions during 3 months:Zollinger-Ellison syndrome, the primary esophageal motility disorders achalasia,esophageal stricture, pancreatitis, gastric ulcer, evidence of upper G.I. malignancy,pancreatitis, malabsorption, severe cardiovascular or pulmonary disease, severe liverdisease, severe renal disease, cerebral vascular disease,

  • Known hypersensitivity to any component of drug

  • pregnancy or lactation (F only)

Study Design

Total Participants: 174
Study Start date:
October 01, 2014
Estimated Completion Date:

Connect with a study center

  • Seoul National University Bundang Hospital

    Sung-Nam, Gyeong-gi
    Korea, Republic of

    Active - Recruiting

  • Soon Chun Hyang University Hospital Bucheon

    Bucheon, GyeongGi-Do
    Korea, Republic of

    Active - Recruiting

  • Bundang CHA Medical Center

    Sung-Nam, Gyeonggi-do
    Korea, Republic of

    Active - Recruiting

  • Yeungnam University Medical Center

    Daegu,
    Korea, Republic of

    Active - Recruiting

  • Asan Medical Center

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Gangnam Severance Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Seoul Metropolitan Government Seoul National University Boramae Medical Center

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Seoul St. Mary's Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

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