Lesogaberan in Chinese Patients With Refractory Reflux Symptoms

Phase 2

• Conditions: Gastroesophageal Reflux Disease
• Interventions: Drug: Lesogaberan; Drug: Placebo

• Registration Number: NCT02818309
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

Lesogaberan may be used in Chinese GERD patients with partial response to PPI.

Detailed Description

To test the efficacy and safety of lesogaberan.

Study Timeline

• Study Start: 2015-01
• Status Verified: 2016-06
• Study First Submitted: 2016-06-21
• Study First Submitted QC: 2016-06-27
• Last Update Submitted: 2016-06-27
• Study First Posted: 2016-06-29
• Last Update Posted: 2016-06-29
• Primary Completion: 2017-11
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lesogaberan	Lesogaberan	Lesogaberan
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Treatment response as assessed by the symptom questionnaire RESQ-eD	3 years	Treatment response, defined as at most three days with heartburn or regurgitation of not more than mild intensity during the last 7 days of treatment based on RESQ-eD

Secondary Outcome Measures

Name	Time	Method
The change from baseline for each separate symptom domain of the RESQ-eD	3 years
Patients' consumption of rescue antacid medication over the 4 week treatment period	3 years
Number of participants with treatment-related adverse events as assessed by CRF_20150728	3 years	Adverse events are any untoward medical occurrences in a patient or clinical trial subject to whom a medicinal product has been administered including occurrences which are not necessarily caused by or related to that product. According to previous studies, the common adverse events of lesogaberan include paraesthesia, diarrhea, pruritus, dizziness and nausea. The serious adverse events are defined as following: 1. results in death; 2.; life-threatening; 3. requires hospitalisation or prolongation of existing hospitalisation; 4. results in persistent or significant disability or incapacity
Time to treatment response as assessed by the symptom questionnaire RESQ-eD	3 years	time from the day of the first dose to the first of seven consecutive days meeting the responder definition
Time to sustained absence of symptoms as assessed by the symptom questionnaire RESQ-eD	3 years	time from the day of the first dose to the first of seven consecutive symptom-free days
The proportion of symptom-free days as assessed by the symptom questionnaire RESQ-eD	3 years
Subgroup analysis of in patients with different reflux profiles categorized by impedance-pH as assessed by the symptom questionnaire RESQ-eD	3 years	Treatment response, defined as at most three days with heartburn or regurgitation of not more than mild intensity during the last 7 days of treatment based on RESQ-eD
Patient compliance with treatment determined by counts of returned unused capsules at each visit during the period of randomised treatment	3 years

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan