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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01499368
Other study ID # LAF-BR-CT-302
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date November 2011
Est. completion date November 2012

Study information

Verified date August 2020
Source Boryung Pharmaceutical Co., Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To evaluate the healing rate and safety of Lafutidine in erosive esophagitis


Recruitment information / eligibility

Status Completed
Enrollment 495
Est. completion date November 2012
Est. primary completion date November 2012
Accepts healthy volunteers No
Gender All
Age group 20 Years to 75 Years
Eligibility Inclusion Criteria:

- Patients who had symptoms of heartburn with a diagnosis of grade A to D reflux esophagitis according to the Los Angeles classification

Exclusion Criteria:

- Gastric or duodenal ulcers (excluding ulcer scars)

- Concurrent presence of Barrett's esophagus

- A history of a poor response to H2RA or PPI given in the recommended dose for 8 weeks

- Other conditions considered by the attending physician to potentially affect the assessment of efficacy and safety

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Lafutidine
Lafutidine 20mg/day
Famotidine
Famotidine 40mg/day
Omeprazole
Omeprazole 20mg/day

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Boryung Pharmaceutical Co., Ltd

Outcome

Type Measure Description Time frame Safety issue
Primary Recovery Rates of Reflux Esophagitis Recovery rates of reflux esophagitis on the Esophago Gastro Duodenoscopy test after 8 week treatment-FAS 8 weeks
Secondary The Proportion of Days Without 'Cardinal Symptom' The proportion of days without 'Cardinal symptom' after 4 or 8 week treatment-FAS 'Cardinal symptom': Burning sesation in the chest, Acid reflux, Heartburn including chest pain 4 or 8 week
Secondary The Proportion of Daytimes Without 'Cardinal Symptom' The proportion of daytimes without 'Cardinal symptom' after 4 or 8 week treatment-FAS 'Cardinal symptom': Burning sensation in the chest, Acid reflux, Heartburn including chest pain 4 or 8 week
Secondary The Proportion of Nighttimes Without 'Cardinal Symptom' The proportion of Nighttimes without 'Cardinal symptom' after 4 or 8 treatment-FAS 'Cardinal symptom': Burning sensation in the chest, Acid reflux, Heartburn including chest pain 4 or 8 week
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