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Compound Sodium Alginate Oral Suspension Sachet Symptomatic Relief Study | Clinical Trials | Clareo Health

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Compound Sodium Alginate Oral Suspension Sachet Symptomatic Relief Study

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

NCT02623062•Reckitt Benckiser Healthcare (UK) Limited

View on ClinicalTrials.gov

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).

Detailed Description

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Primary diagnosis: Current evidence of symptomatic GERD/NERD that comply with the Montreal definition of GERD/Nonerosive Esophageal Reflux Disease (NERD). GERD is a condition which develops when the reflux of stomach contents causes troublesome symptoms and/or complications. The concept of NERD is preserved in the typical reflux syndrome without esophageal injury, while reflux esophagitis falls under the category of esophageal syndromes with esophageal injury.
•GERD status: patients will be recruited by the Investigator from out-patient clinics, hospital database or those who respond to the advertising. Patients must have a GERD history of frequent episodes of GERD-related symptoms during the last 3 months, and must have had troublesome heartburn and/or regurgitation of at least moderate intensity on at least 4 days during the week before the start of screening.
•Patients must be sufficiently literate to be able to complete the RDQ unaided.

Exclusion Criteria

•Patients who have a history of drug, solvent or alcohol abuse (weekly alcohol intake ≥ 140g).
•Patients who have suffered cardiac chest pain within the last year.
•Patients who have suffered a recent, significant unexplained weight loss of more than 6 kg in the last 6 months.
•Female patients of childbearing potential who, for the duration of the study, are either unwilling or unable to take adequate contraceptive precautions or are unwilling to be sexually abstinent.
•Pregnancy or lactating mother.
•Patients with a history and/or symptom profile suggestive of the following: any other gastrointestinal (GI) disease (e.g. gastric or duodenal erosions and polyps larger than 0.5 cm), erosive GERD (Los Angeles \[LA\] classification grades C-D), Barrett's esophagus, peptic ulcer and/or ulcer complications, Zollinger-Ellison syndrome, gastric carcinoma, pyloric stenosis, oesophageal or gastric surgery, intestinal obstruction, current pernicious anaemia, indication for H-pylori eradication, hiatal hernias greater than 3 cm, known gastro-intestinal bleeding (hematochezia or hematemesis) within the last 3 months, and severe diseases of other major body systems.
•Patients who have taken anti-cholinesterase drugs, traditional Chinese medicines for treating gastrointestinal disease, Ulcermin or misoprostol preparations within 7 days prior to screening or throughout the study.
•Patients who have taken Proton Pump Inhibitors (PPIs) during the 10 days prior to screening, prokinetics or H2 antagonists during the 5 days prior to screening, or systemic glucocorticosteroids, non-steroidal anti-inflammatory drugs (NSAIDs except low dose aspirin given for cardioprotection) on more than 3 consecutive days during the last 28 days prior to screening or PPI-based triple or quadruple therapy for eradication of H-pylori during the last 28 days prior to screening and throughout the study.
•Patients who have taken any antacids within 24 hours before randomisation (Visit 2) and are unwilling or unable to withhold from taking them for the duration of the study.
•Patients taking mucous membrane protection drugs or motility stimulants within the 5 days prior to screening and are unwilling or unable to withhold from taking them for the duration of the study.
+16 more criteria

Locations (1)

The First Affilated Hospital Sun Yat-Sen University

Guangzhou, Guangdong, China

Key Dates

Start Date

December 1, 2013

Primary Completion Date

March 1, 2016

Completion Date

May 1, 2016

Last Updated

June 3, 2016

Enrollment

644

ACTUAL participants

Conditions

Gastro-esophageal Reflux Disease (GERD)

Interventions

Compound Sodium Alginate Oral Suspension sachet

DRUG

Matched placebo

DRUG

FODMAPs and Refractory GERD

NCT02471989

Gastro-esophageal Reflux Disease (GERD)

View study

WITHDRAWNNA

HRIM vs Mucosal Impedance in GERD Participants

NCT02812407

Gastro-esophageal Reflux Disease (GERD)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 3, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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