A multicentre, randomised, double-blind, two arm, parallel group, placebo controlled, pilot study to assess the effect of Gaviscon Advance as add-on therapy in GORD patients with inadequate response to once daily proton pump inhibitor treatment.

Reckitt Benckiser Healthcare (UK) Ltd.0 sites150 target enrollmentOctober 8, 2012

ConditionsGastro Oesophageal Reflux Disease (GORD)MedDRA version: 17.1Level: LLTClassification code 10066874Term: Gastroesophageal reflux diseaseSystem Organ Class: 100000004856 Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

DrugsGaviscon Advance

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Gastro Oesophageal Reflux Disease (GORD)
Sponsor: Reckitt Benckiser Healthcare (UK) Ltd.
Enrollment: 150
Status: Active, not recruiting
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

October 8, 2012

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Reckitt Benckiser Healthcare (UK) Ltd.

Eligibility Criteria

Inclusion Criteria

•1\) Male or female patients aged at least 18 years.
•2\) Evidence of symptomatic GORD, despite current treatment with the optimum individualized dose of a once daily proton pump inhibitor. GORD symptoms should be such that the Investigator believes it is likely that the patient will achieve a score of 18 during one week of treatment with a PPI before randomization (as described in Section 10\.3: Additional Inclusion Criteria for Randomisation, number 2\).
•3\) Treatment with once daily PPI for at least the previous 4 weeks.
•4\) Compliance regarding use of prescribed once\-daily PPI over 4 weeks, as determined by the investigator.
•5\) Provision of written informed consent.
•Additional Inclusion Criteria for Randomisation
•Following the 7\-day run in period, patients will be assessed against the following inclusion criteria before randomisation.
•1\) Completion of the run\-in diary card and questionnaires on each of the seven days of the run\-in period.
•2\) At least one reflux symptom (heartburn or regurgitation) of at least moderate intensity measured during the 7\-day run\-in period (from the HRDQ questionnaire) and a summarised 7\-day score of at least 18 (e.g. corresponding to 3 days with moderate heartburn 3 times a day). (The daily score will be calculated as intensity x frequency, where intensity is scored as 0 \= none, 1 \= mild, 2 \=
•moderate and 3 \= severe and frequency is scored as 0 \= none, 1 \= once, 2 \= twice, 3 \= thrice, 4 \= 4 or 5 times, 5 \= 6 – 10 times and 6 \= more than 10 times or constant).

Exclusion Criteria

•1\) Oesophageal stricture, peptic ulcer disease, Zollinger\-Ellison syndrome, systemic sclerosis, recent upper gastrointestinal endoscopy examination that has shown LA grade C or D oesophagitis.
•2\) Drug, solvent or alcohol abuse (weekly alcohol intake \= 140g) within the 3 months before screening.
•3\) Cardiac chest pain within the 3 months before screening.
•4\) Recent, significant unexplained weight loss of greater than 6 kg in the last 6 months.
•5\) Gastro\-intestinal bleeding (hematochezia or hematemesis) within the last 3 months.
•6\) Allergy or known intolerance to any of the study drug excipients: carbomer, methyl parahydroxybenzoate, propyl parahydroxybenzoate, saccharin sodium, fennel flavour and sodium hydroxide, or the following formulation constituents:
•sodium alginate, calcium carbonate, potassium bicarbonate, methyl titanium dioxide and xanthan gum.
•7\) Use of antidepressants, non\-steroidal anti\-inflammatory drugs or other analgesics that might, in the opinion of the investigator, compromise symptom recording.
•8\) Current enrollment in another study or involvement in a previous symptom relief Gaviscon study.
•9\) Previous surgery of the oesophagus, stomach or duodenum.