Gastro-esophageal Reflux Disease (GERD) Clinical Trial
Official title:
A Multi-centred, Randomised, Double-blind, Two Arms, Parallel Group, Placebo-controlled Study to Assess the Effect of Compound Sodium Alginate Oral Suspension Sachet in Patients With Reflux Disease
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).
This is a multi-centre, randomised, double blind, two arm, parallel group,
placebo-controlled clinical trial in patients with moderate to severe and frequent GERD
symptoms. After signing a written informed consent, patients will undergo a screening period
of up to 7 days. Patients who satisfy the study entry requirements within 7 days of consent,
will be randomised to receive either Compound Sodium Alginate Oral Suspension sachets (20ml
four times daily) or matching placebo sachets (20ml four times daily),for a 7- day treatment
period. At the beginning and end of the treatment period, patients will be required to
complete the Reflux Disease Questionnaire (RDQ).
In addition, at the end of the 7 (-1 day to +2 days) day treatment period, patients will be
required to complete the Overall Treatment Evaluation.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT02471989 -
FODMAPs and Refractory GERD
|
N/A | |
| Withdrawn |
NCT02812407 -
HRIM vs Mucosal Impedance in GERD Participants
|
N/A | |
| Terminated |
NCT02619747 -
Compound Sodium Alginate Oral Suspension Sachet 4-hour Esophageal pH Study in GERD Patients
|
Phase 3 |