Gaviscon double action versus placebo study using the BRAVO System

Not Applicable

Completed

• Conditions: Gastroesophageal reflux disease; Digestive System

• Registration Number: ISRCTN52169198
• Lead Sponsor: Reckitt Benckiser Healthcare (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08-19
• Last Update Posted: 22 May 2017

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Aged greater than or equal to 18 years and less than or equal to 70 years
2. Male and female patients
3. Primary diagnosis is those with self-rated at least moderate heartburn or acid regurgitation within 60 minutes following ingestion of a refluxogenic meal on at least three occasions a week at the screening visit
4. Agreement to withhold acid suppressant PPI and H2 receptor blocking medications and other medications that affect gastro-intestinal function for 6 days and 3 days respectively prior to the test and during 4 days of monitoring
5. Agreement to withhold antacids or alginate preparations, except those administered as part of study procedures for 1 day prior to the test and during 4 days of monitoring
6. Patients who gave written informed consent

Exclusion Criteria

1. Those with prominent gastrointestinal symptoms or disease other than reflux (including atypical symptoms, e.g. cough, sore throat, belching, nausea)
2. Those with difficulty swallowing (dysphagia), gastrointestinal bleeding, weight loss (greater than 5% body weight) or other alarm symptoms suggestive of neoplastic or severe inflammatory disease within the last 12 months
3. Those with a history or symptoms suggestive of Zollinger-Ellison syndrome, gastric carcinoma, previous or current peptic ulcer disease, pernicious anaemia, Barrett's oesophagus or systemic sclerosis
4. Those with a history of upper GI surgery or endoscopic interventions such as oesophageal dilatations or mucosal resection
5. Those with known hypophosphataemia or phenylketonuria
6. Those with severe constipation or history of colonic stenosis
7. Those with major oesophageal dysmotility on manometry, e.g. achalasia
8. Those with severe reflux oesophagitis on endoscopy (LA grade III - IV) or Barrett's oesophagus on endoscopy
9. Those with significant co-morbidity requiring ongoing treatment or investigation
10. Those with haematological disorders, bleeding tendency, recurrent nose bleeds or treatment with anti-coagulants
11. Those with physical, neurological or psychiatric conditions preventing repeated visits to hospital or compliance with study procedures (e.g. physical impairment/reduced mobility)
12. Woman of childbearing potential, who are pregnant or lactating, seeking pregnancy or failing to take adequate contraceptive precautions, (i.e. sexual an oral or injectable contraceptive, an approved hormonal implant or topical patch, an intrauterine device, abstinence [should the subject become sexually active, she must agree to use a double barrier method]). A woman of childbearing potential is defined as any female who has not undergone the menopause or has not had an hysterectomy or surgical sterilisation procedure, e.g. bilateral tubal ligation, bilateral ovariectomy (oophorectomy).
13. Those that do not withhold acid-suppressant PPI and H2 receptor blocking medications for 6 days and 3 days respectively prior to the test and during 4 days of monitoring
14. Those that do not withhold antacid or alginate medications for 1 days prior to the test and during 4 days of monitoring (5 days in total)
15. Those who have any previous history of allergy or known intolerance to any of the study drugs or the following formulation constituents: Gaviscon® liquid: sodium alginate, sodium bicarbonate, calcium carbonate, carbomer, methyl parahydroxybenzoate, propyl parahydroxybenzoate, saccharin sodium, peppermint flavour, sodium hydroxide, Placebo: hydrogenated glucose syrup, peppermint flavour, potassium sorbate, methyl paraben, xanthan gum r80, propyl paraben, citric acid
16. Failure to accept or to comply with standard requirements for activity and diet during pH testing
17. Those unable in the opinion of the Investigator to comply fully with the study requirements

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The number of acid reflux events during 48 hour Gaviscon Double Action or matched placebo study period compared to the 48 hour 'no treatment' study period