S-pantoprazole 10mg Phase III Clinical Study

Sponsor

Ahn-Gook Pharmaceuticals Co.,Ltd (Industry)

Overall Status

Unknown status

CT.gov ID

NCT02274961

Collaborator

(none)

174

Enrollment

Locations

Arms

17.4

Patients Per Site

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Non Erosive Reflux Disease	Drug: S-pantoprazole 10mg Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

174 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Study Start Date :

Oct 1, 2014

Anticipated Primary Completion Date :

Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: S-pantoprazole 10mg S-pantoprazole 10mg Tablet once daily for 4 weeks	Drug: S-pantoprazole 10mg
Placebo Comparator: Placebo Placebo tablet for the test drug	Drug: Placebo

Arm

Intervention/Treatment

Experimental: S-pantoprazole 10mg

S-pantoprazole 10mg Tablet once daily for 4 weeks

Drug: S-pantoprazole 10mg

Placebo Comparator: Placebo

Placebo tablet for the test drug

Drug: Placebo

Outcome Measures

Primary Outcome Measures

To assess the efficacy , as defined by complete resolution of heartburn (HB) per Questionnaire, of 4 weeks of treatment of S-pantoprazole 10mg qd compared to Placebo in subjects with symptomatic gastro-esophageal reflux disease [4 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 to baseline
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 all procedures of the study

Exclusion Criteria:

History of endoscopic erosive esophagitis(EE) at screening EGD.
Historical evidence of the following disease/conditions : symptom of Irritable bowel syndrome
More tha 3cm endoscopic Barrett's esophagus or significant dysplastic changes in the esophagus
Proton Pump Inhibitor(PPI) within 4 weeks prior to the baseline visit
H2-receptor antagonist, sucralfate, prokinetics, Non Steroidal Antiinflammatory Drugs(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 liver disease, severe renal disease, cerebral vascular disease,
Known hypersensitivity to any component of drug
pregnancy or lactation (F only)

Contacts and Locations

Locations

	Site	City	State	Country
1	Seoul National University Bundang Hospital	Sung-Nam	Gyeong-gi	Korea, Republic of
2	Soon Chun Hyang University Hospital Bucheon	Bucheon	GyeongGi-Do	Korea, Republic of
3	Bundang CHA Medical Center	Sung-Nam	Gyeonggi-do	Korea, Republic of
4	Yeungnam University Medical Center	Daegu		Korea, Republic of
5	Asan Medical Center	Seoul		Korea, Republic of
6	Gangnam Severance Hospital	Seoul		Korea, Republic of
7	Seoul Metropolitan Government Seoul National University Boramae Medical Center	Seoul		Korea, Republic of
8	Seoul National University Hospital	Seoul		Korea, Republic of
9	Seoul St. Mary's Hospital	Seoul		Korea, Republic of
10	Severance Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

Ahn-Gook Pharmaceuticals Co.,Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ahn-Gook Pharmaceuticals Co.,Ltd

ClinicalTrials.gov Identifier:

NCT02274961

Other Study ID Numbers:

LTP10_KR_1301

First Posted:

Oct 27, 2014

Last Update Posted:

Oct 27, 2014

Last Verified:

Oct 1, 2014

Additional relevant MeSH terms:

Gastroesophageal Reflux

Pantoprazole

Study Results

No Results Posted as of Oct 27, 2014