Compound Sodium Alginate Oral Suspension Sachet Symptomatic Relief Study

NCT02623062 | Completed Phase 3

• 1 other identifier: GA1217
• Study Type: interventional
• Target: 644
• Locations: 1 country
• Sites: 1

Brief 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)

Outcome Measures

Primary Outcomes (1)

• Change in GERD dimension of RDQ

  Change from day 0 in the GERD dimension (heartburn and regurgitation combined) from the RDQ symptom scores after a 7-day treatment period

  0 and 7 days

Secondary Outcomes (4)

• Change in symptom score for each dimension of the RDQ separately

  0 and 7 days

• Change in frequency of each symptom separately (heartburn and regurgitation) from RDQ assessment

  0 and 7 days

• Change in intensity of each symptom separately (heartburn and regurgitation) from RDQ assessment

  0 and 7 days

• Change in symptoms using the Overall Treatment Evaluation (OTE)

  0 and 7 days

Study Arms (2)

Compound Sodium Alginate Oral Suspension sachets

ACTIVE COMPARATOR

Each patient will be instructed to take Compound Sodium Alginate Oral Suspension sachet or matching placebo as a 2x10ml sachets four times daily regimen. Prior to dosing, all patients will be instructed by the Investigator on how they will take the medication. Patients will be instructed to start taking their medication the day after their randomisation visit (Day 1) for seven days (20ml taken four times a day: 30 minutes after breakfast, 30 minutes after lunch, 30 minutes after dinner and immediately before lying down for bed. Shake well before use).

Drug: Compound Sodium Alginate Oral Suspension sachet

Matching placebo sachets

PLACEBO COMPARATOR

Each patient will be instructed to take Compound Sodium Alginate Oral Suspension sachet or matching placebo as a 2x10ml sachets four times daily regimen. Prior to dosing, all patients will be instructed by the Investigator on how they will take the medication. Patients will be instructed to start taking their medication the day after their randomisation visit (Day 1) for seven days (20ml taken four times a day: 30 minutes after breakfast, 30 minutes after lunch, 30 minutes after dinner and immediately before lying down for bed. Shake well before use).

Drug: Matched placebo

Interventions

Compound Sodium Alginate Oral Suspension sachet DRUG

Contents of 2 sachets taken four times daily for 7 days

Also known as: Gaviscon sachets

Compound Sodium Alginate Oral Suspension sachets

Matched placebo DRUG

Contents of 2 sachets taken four times daily for 7 days

Also known as: Placebo

Matching placebo sachets

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Patients with difficulty in swallowing.
• Patients with known hypophosphataemia, phenylketonuria or hypercalcaemia.
• Patients with severe constipation, or history of intestinal obstruction.
• In the opinion of the Investigator, patients with insufficient heart or kidney function and patients who require a low sodium diet.
• Patients with any co-existing condition which, in the opinion of the Investigator, would be likely to compromise patient safety or interfere with assessment of efficacy.

Sponsors & Collaborators

• Reckitt Benckiser Healthcare (UK) Limited: lead

Study Sites (1)

The First Affilated Hospital Sun Yat-Sen University

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• MinHu Chen

  First Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2015
• First Posted: December 7, 2015
• Study Start: December 1, 2013
• Primary Completion: March 1, 2016
• Study Completion: May 1, 2016
• Last Updated: June 3, 2016

Record last verified: 2016-06

Locations

CN (1)