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Compound Sodium Alginate Double Action Chewable Tablets 4-hour Esophageal pH Study in GERD Patients

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ClinicalTrials.gov Identifier: NCT01872897
Recruitment Status : Completed
First Posted : June 7, 2013
Last Update Posted : January 9, 2014
Sponsor:
Information provided by (Responsible Party):
Reckitt Benckiser Healthcare (UK) Limited

Brief Summary:
This study is being conducted to assess the effectiveness of the Compound Sodium Alginate Double Action Chewable Tablets compared to placebo on acidic reflux events into the esophagus in patients diagnosed with Gastroesophageal Reflux Disease (GERD).

Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Disease Drug: Sodium Alginate Double Action Tablets Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-centred, 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 Double Action Tablets or Placebo Tablets
Study Start Date : June 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Arm Intervention/treatment
Active Comparator: Sodium Alginate Double Action Tablets
Four Compound Sodium Alginate Double Action Chewable Tablets administered as a single dose
Drug: Sodium Alginate Double Action Tablets
Four tablets as a single dose
Other Name: Gaviscon Double Action Tablets

Placebo Comparator: Placebo tablets
Single dose of 4 Placebo tablets
Drug: Placebo
4 tablets as a single dose




Primary Outcome Measures :
  1. Percentage of time during the 4 hour post dosing period with pH below pH 4 [ Time Frame: 0 to 4 hours post dose ]
    The primary efficacy endpoint will be the percentage of time during the 4 hour post dosing period with pH below pH 4 for Compound Sodium Alginate Double Action Chewable Tablets versus matching placebo.


Secondary Outcome Measures :
  1. Percentage of time during the 4 hour post dosing period with pH below pH 5 [ Time Frame: 0 to 4 hours post-dose ]
    Percentage of time during the 4 hour post dosing period with pH below pH 5 for Compound Sodium Alginate Double Action Chewable Tablets versus matching placebo tablets

  2. Number of occasions during the 4 hour post dosing period when pH falls below pH 4 [ Time Frame: 0 to 4 hours post-dose ]
    Number of occasions during the 4 hour post dosing period when pH falls below pH 4 for Compound Sodium Alginate Double Action Chewable Tablets versus matching placebo tablets

  3. Number of reflux episodes during the 4 hour post dosing period with pH below pH 4 for at least 5 minutes [ Time Frame: 0 to 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 for Compound Sodium Alginate Double Action Chewable Tablets versus matching placebo tablets

  4. Percentage of time during the first hour post dosing with pH below pH 4 [ Time Frame: 0 to 1 hour post-dose ]
    Percentage of time during the first hour post dosing with pH below pH 4 for Compound Sodium Alginate Double Action Chewable Tablets versus matching placebo tablets

  5. Percentage of time during the first hour post dosing with pH below pH 5 [ Time Frame: 0 to 1 hour post-dose ]
    Percentage of time during the first hour post dosing with pH below pH 5 for Compound Sodium Alginate Double Action Chewable Tablets versus matching placebo tablets

  6. Number of occasions during the first hour post dosing when pH falls below pH 4 [ Time Frame: 0 to 1 hour post-dose ]
    Number of occasions during the first hour post dosing when pH falls below pH 4 for Compound Sodium Alginate Double Action Chewable Tablets versus matching placebo tablets

  7. Number of occasions during the first hour post dosing when pH falls below pH 5 [ Time Frame: 0 to 1 hour post-dose ]
    Number of occasions during the first hour post dosing when pH falls below pH 5 for Compound Sodium Alginate Double Action Chewable Tablets versus matching placebo tablets

  8. The longest reflux time during the 4 hour post dosing period (i.e. the longest period with pH below pH 4) [ Time Frame: 0 to 4 hours post-dose ]
    The longest reflux time during the 4 hour post dosing period (i.e. the longest period with pH below pH 4) for Compound Sodium Alginate Double Action Chewable Tablets versus matching placebo tablets

  9. The DeMeester scores during the 4 hour post dosing period [ Time Frame: 0 to 4 hours post-dose ]
    The DeMeester scores during the 4 hour post dosing period for Compound Sodium Alginate Double Action Chewable Tablets versus matching placebo tablets



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:

  • meets the diagnostic criteria for GERD with a GERD history of frequent episodes of GERD-related symptoms during the last 2 months prior to study screening. The patient must also meet the following criteria:

    1. The only or main symptom is heartburn (burning feeling back of breast bone) and/or acid reflux. Symptoms persists or have occurred repeatedly for more than 2 months;
    2. As assessed by the Investigator at screening by questioning of the patient, the frequency of occurrence of heartburn is ≥ 3 days/week and the score of severity of heartburn in general is ≥ moderate within 3 weeks before screening

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, 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, indication for H-pylori eradication therapy, known gastro-intestinal bleeding (hematochezia or hematemesis) within the last 3 months, and severe diseases of other major body systems.
  • Patients who are observed at screening to have a hiatus hernia with a diameter which exceeds 3cm.
  • Patients who have taken anti-cholinesterase drugs, traditional Chinese medicines for treating gastrointestinal disease, ulcerlmin or misoprostol preparations within 7 days prior to screening or throughout the study.
  • Patients who have taken 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 for low dose aspirin which can be given for cardioprotection) on more than 3 consecutive days or PPI-based triple or quadruple therapy for eradication of H-pylori during the last 28 days.
  • Patients taking or requiring to take macrolide antibiotics, such as erythromycin, azithromycin, from the day before screening.
  • 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 damaged heart or kidney function and patients who require a low sodium diet.

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): NCT01872897


Locations
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China
RB Investigational Sites
Shanghai, China
Sponsors and Collaborators
Reckitt Benckiser Healthcare (UK) Limited
Investigators
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Principal Investigator: Yuan Yaozong, MD, PhD Shanghai Jiatong University, School of Medicine, Shanghai, China

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Responsible Party: Reckitt Benckiser Healthcare (UK) Limited
ClinicalTrials.gov Identifier: NCT01872897     History of Changes
Other Study ID Numbers: GA1202
First Posted: June 7, 2013    Key Record Dates
Last Update Posted: January 9, 2014
Last Verified: January 2014

Keywords provided by Reckitt Benckiser Healthcare (UK) Limited:
Gastroesophageal Reflux Disease
GERD
Acid reflux
Compound Sodium Alginate Double Action Chewable Tablet
Gaviscon Double Action Tablets

Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophagitis, Peptic
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Esophagitis
Gastroenteritis
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases
Alginate, aluminium hydroxide, magnesium trisilicate, sodium bicarbonate drug combination
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents