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Compound Sodium Alginate Oral Suspension Sachet Symptomatic Relief Study

NCT02623062 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 644

Last updated 2016-06-03

No results posted yet for this study

Summary

This study is being conducted in China to provide evidence for inclusion in applications to competent authorities that the Compound Sodium Alginate Oral Suspension sachet is effective in managing the symptoms of heartburn and acid regurgitation in patients with gastro-esophageal reflux disease (GERD).

Conditions

  • Gastro-esophageal Reflux Disease (GERD)

Interventions

DRUG

Compound Sodium Alginate Oral Suspension sachet

Contents of 2 sachets taken four times daily for 7 days

DRUG

Matched placebo

Contents of 2 sachets taken four times daily for 7 days

Sponsors & Collaborators

  • Reckitt Benckiser Healthcare (UK) Limited

    lead INDUSTRY

Principal Investigators

  • MinHu Chen · First Affiliated Hospital, Sun Yat-Sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2016-03-31
Completion
2016-05-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02623062 on ClinicalTrials.gov