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

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ClinicalTrials.gov Identifier: NCT02619747
Recruitment Status : Terminated (Problems with recruitment)
First Posted : December 2, 2015
Last Update Posted : October 6, 2017
Sponsor:
Information provided by (Responsible Party):
Reckitt Benckiser Healthcare (UK) Limited

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

Condition or disease Intervention/treatment Phase
Gastro-esophageal Reflux Disease (GERD) Drug: Compound Sodium Alginate Oral Suspension sachet Drug: Matched placebo Phase 3

Detailed Description:

This is a multi-centre, randomised, open-label, placebo-controlled, two-period crossover study. After signing a written informed consent (ICF), patients will undergo a screening period of up to 10 days (Visit 1) which will require the patient to return to the clinic on several occasions. At the start of the screening process patients will have 24 hour (h) pH monitoring which will include one standardised refluxogenic meal after a 4 h fast. The 24 h pH monitoring results will be used as a key criteria for patient eligibility and to provide the patients with diagnostic information on their symptoms. After 24 h pH monitoring, eligible patients will be supplied with Compound Sodium Alginate Oral Suspension sachet to take as required for symptom relief between visits (up to 2×10ml sachets four times daily: 30 minutes after breakfast, 30 minutes after lunch, 30 minutes after dinner and immediately before lying down for bed, stopping dosing at least 24 hours prior to Visit 2).

Patients who satisfy the study entry requirements within 10 days of consent, will be randomised to receive either two Compound Sodium Alginate Oral Suspension sachets (2×10ml) or two placebo sachets (2×10ml) following placement of a pH electrode after a 4 h fast and a standardised refluxogenic meal at Visit 2.

Upon completion of the Visit 2 4-hour post-dose pH monitoring period patients will be re-supplied with Compound Sodium Alginate Oral Suspension sachets to take as required for symptom relief (up to 2×10ml sachets four times daily: 30 minutes after breakfast, 30 minutes after lunch, 30 minutes after dinner and immediately before lying down for bed, stopping dosing at least 24 hours prior to Visit 3) for 7 ± 2 days. Patients will return for Visit 3 after 7 ± 2 days. Visit 3 will consist of repeat pH catheter insertion (4 hour fast followed by refluxogenic test meal consumption) and pH monitoring, receiving the alternative randomised treatment at Visit 3.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Multi-centre, Randomised, Open Label, Placebo-controlled, Two-period Crossover Study to Evaluate 4-hour Esophageal pH Change in GERD Patients After Administration of Compound Sodium Alginate Oral Suspension Sachets or Placebo Sachets
Actual Study Start Date : April 2014
Actual Primary Completion Date : March 31, 2017
Actual Study Completion Date : March 31, 2017

Arm Intervention/treatment
Active Comparator: Compound Sodium Alginate Oral Suspension sachet
Single dose of contents of two 10 ml sachets of Compound Sodium Alginate Oral Suspension
Drug: Compound Sodium Alginate Oral Suspension sachet
Other Name: Gaviscon sachets

Drug: Matched placebo
Placebo Comparator: Matched placebo
Single dose of contents of two 10 ml sachets of matched placebo
Drug: Compound Sodium Alginate Oral Suspension sachet
Other Name: Gaviscon sachets

Drug: Matched placebo



Primary Outcome Measures :
  1. Percentage of time during the 4 hour post dosing period with pH below pH 4. [ Time Frame: 4 hours post-dose ]

Secondary Outcome Measures :
  1. Percentage of time during the 4 hour post dosing period with pH below pH 5 [ Time Frame: 4 hours post-dose ]
  2. Number of occasions during the 4 hour post dosing period when pH falls below pH 4 [ Time Frame: 4 hours post-dose ]
  3. Number of occasions during the 4 hour post dosing period when pH falls below pH 5 [ Time Frame: 4 hours post-dose ]
  4. Number of reflux episodes during the 4 hour post dosing period with pH below pH 4 for at least 5 minutes [ Time Frame: 4 hours post-dose ]
  5. Percentage of time during the first hour post dosing with pH below pH 4 [ Time Frame: 1 hour post-dose ]
  6. Percentage of time during the first hour post dosing with pH below pH 5 [ Time Frame: 1 hour post-dose ]
  7. Number of occasions during the first hour post dosing when pH falls below pH 4 [ Time Frame: 1 hour post-dose ]
  8. Number of occasions during the first hour post dosing when pH falls below pH 5 [ Time Frame: 1 hour post-dose ]
  9. The longest reflux time during the 4 hour post dosing period [ Time Frame: 4 hours post-dose ]
  10. DeMeester score [ Time Frame: 4 hours post-dose ]
  11. Overall proportion of patients with adverse events (AEs) [ Time Frame: 20 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

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, 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.
  • In the opinion of the Investigator, patients with insufficient heart or kidney function and patients who require a low sodium diet.
  • Patients either 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; or with any clinically significant abnormal laboratory values.
  • Patients with impaired renal function or severe renal insufficiency.
  • Any previous history of allergy or known intolerance to any of the formulation constituents
  • Clinically significant abnormalities in the physical examination, electrocardiogram (ECG) and safety analysis.
  • Patients taking or requiring to take macrolide antibiotics, such as erythromycin, azithromycin, from the day before screening.
  • Previously randomised into the study.
  • Employee at study site.
  • Partner or first-degree relative of the Investigator.
  • Participation in a clinical study in the previous 6 months.
  • Unable in the opinion of the Investigator to comply fully with the study requirements.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02619747


Locations
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China, Guangdong
The First Affilated Hospital Sun Yat-Sen University
Guangzhou, Guangdong, China, 510080
Sponsors and Collaborators
Reckitt Benckiser Healthcare (UK) Limited
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Responsible Party: Reckitt Benckiser Healthcare (UK) Limited
ClinicalTrials.gov Identifier: NCT02619747    
Other Study ID Numbers: GA1218
First Posted: December 2, 2015    Key Record Dates
Last Update Posted: October 6, 2017
Last Verified: October 2017
Keywords provided by Reckitt Benckiser Healthcare (UK) Limited:
pH monitoring
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Alginate, aluminium hydroxide, magnesium trisilicate, sodium bicarbonate drug combination
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents