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

Gastroesophageal Reflux Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01872897
• Other study ID #: GA1202
• Status: Completed
• Phase: Phase 3
• First received: May 31, 2013
• Last updated: January 8, 2014
• Start date: June 2013
• Est. completion date: December 2013

Study information

• Verified date: January 2014
• Source: Reckitt Benckiser Healthcare (UK) Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

Drug:
• Sodium Alginate Double Action Tablets
Four tablets as a single dose
• Placebo
4 tablets as a single dose

Locations

Country	Name	City	State
China	RB Investigational Sites	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Reckitt Benckiser Healthcare (UK) Limited

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of time during the 4 hour post dosing period with pH below pH 4	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.	0 to 4 hours post dose	No
Secondary	Percentage of time during the 4 hour post dosing period with pH below pH 5	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	0 to 4 hours post-dose	No
Secondary	Number of occasions during the 4 hour post dosing period when pH falls below pH 4	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	0 to 4 hours post-dose	No
Secondary	Number of reflux episodes during the 4 hour post dosing period with pH below pH 4 for at least 5 minutes	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	0 to 4 hours post-dose	No
Secondary	Percentage of time during the first hour post dosing with pH below pH 4	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	0 to 1 hour post-dose	No
Secondary	Percentage of time during the first hour post dosing with pH below pH 5	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	0 to 1 hour post-dose	No
Secondary	Number of occasions during the first hour post dosing when pH falls below pH 4	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	0 to 1 hour post-dose	No
Secondary	Number of occasions during the first hour post dosing when pH falls below pH 5	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	0 to 1 hour post-dose	No
Secondary	The longest reflux time during the 4 hour post dosing period (i.e. the longest period with pH below pH 4)	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	0 to 4 hours post-dose	No
Secondary	The DeMeester scores during the 4 hour post dosing period	The DeMeester scores during the 4 hour post dosing period for Compound Sodium Alginate Double Action Chewable Tablets versus matching placebo tablets	0 to 4 hours post-dose	No