Compound Sodium Alginate Oral Suspension Sachet 4-hour Esophageal pH Study in GERD Patients

NCT02619747 | Terminated Phase 3

• 1 other identifier: GA1218
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Multi-centre, randomised, open-label, placebo-controlled, two-period crossover study of 4 hour pH monitoring following a refluxogenic meal and drink.

Conditions

Gastro-esophageal Reflux Disease (GERD)

Keywords

pH monitoring

Outcome Measures

Primary Outcomes (1)

• Percentage of time during the 4 hour post dosing period with pH below pH 4.

  4 hours post-dose

Secondary Outcomes (11)

• Percentage of time during the 4 hour post dosing period with pH below pH 5

  4 hours post-dose

• Number of occasions during the 4 hour post dosing period when pH falls below pH 4

  4 hours post-dose

• Number of occasions during the 4 hour post dosing period when pH falls below pH 5

  4 hours post-dose

• Number of reflux episodes during the 4 hour post dosing period with pH below pH 4 for at least 5 minutes

  4 hours post-dose

• Percentage of time during the first hour post dosing with pH below pH 4

  1 hour post-dose

Study Arms (2)

Compound Sodium Alginate Oral Suspension sachet

ACTIVE COMPARATOR

Single dose of contents of two 10 ml sachets of Compound Sodium Alginate Oral Suspension

Drug: Compound Sodium Alginate Oral Suspension sachet; Drug: Matched placebo

Matched placebo

PLACEBO COMPARATOR

Single dose of contents of two 10 ml sachets of matched placebo

Drug: Compound Sodium Alginate Oral Suspension sachet; Drug: Matched placebo

Interventions

Compound Sodium Alginate Oral Suspension sachet DRUG

Also known as: Gaviscon sachets

Compound Sodium Alginate Oral Suspension sachet; Matched placebo

Matched placebo DRUG

Compound Sodium Alginate Oral Suspension sachet; Matched placebo

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 in accord with the Montreal definition. Patients should have a GERD history of frequent episodes of GERD-related symptoms during at least the last 2 months prior to study screening. The patient must also meet the following criteria:
• The main symptom is heartburn and/or acid reflux. Symptoms persist or have occurred repeatedly for at least the last 2 months;
• The frequency of occurrence of heartburn is ≥ 3 days/week and the score of severity of heartburn in general is moderate or severe within 3 weeks before screening
• Patients who are willing to consume the entire standard refluxogenic test meal.
• Patients who have a screening 24 h pH monitoring test assessing the percentage of time when the pH falls below pH 4 which confirms significant acid reflux of \>4.2% over the 24 h period.

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, acute peptic ulcer and/or ulcer complications, Zollinger-Ellison syndrome, gastric carcinoma, pyloric stenosis, oesophageal or gastric surgery, intestinal obstruction, current pernicious anaemia, hiatal hernias greater than 3 cm, requirement for low sodium diet, known gastrointestinal 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, sucralfate or misoprostol preparations within 7 days prior to screening or throughout the study.
• Patients who have taken Proton Pump Inhibitors (PPIs) during the 28 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.
• Patients who have taken any antacids within 24 hours before screening (Visit 1) and throughout the remainder of the study.
• Patients taking mucous membrane protection drugs or motility stimulants for 5 days prior to screening and throughout the study.
• Patients who are vegetarian.
• Patients with difficulty in swallowing.
• Patients with known hypophosphataemia, phenylketonuria or hypercalcaemia.
• Patients who have previously undergone esophageal, gastric or duodenal surgery at any time or who have undergone any other major surgery with general anaesthesia within the last three months.
• Patients with severe constipation, or history of intestinal obstruction.

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 Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2015
• First Posted: December 2, 2015
• Study Start: April 1, 2014
• Primary Completion: March 31, 2017
• Study Completion: March 31, 2017
• Last Updated: October 6, 2017

Record last verified: 2017-10

Locations

CN (1)