Gastro Oesophageal Reflux Disease (GORD) MedDRA version: 15.1 Level: LLT Classification code 10066874 Term: Gastroesophageal reflux disease System Organ Class: 100000004856
Conditions
Interventions
Trade Name: Gaviscon Advance
Product Name: Gaviscon Advance
Product Code: Gaviscon Advance Oral suspension
Pharmaceutical Form: Oral suspension
INN or Proposed INN: POTASSIUM BICARBONATE
CAS Number: 2
Sponsors
Reckitt Benckiser Healthcare (UK) Ltd.
Eligibility
Sex/Gender
All
Inclusion 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). 3) Compliance with PPI treatment (once daily in the morning) on all seven days of the run-in period. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 135 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
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. 10) History of hypercalcaemia or nephrocalcinosis. 11) Potential language problems in understanding information and recording symptoms. 12) Pregnancy or breast feeding. 13) Any co-existing condition which, in the opinion of the investigator, would be likely to compromise patient safety or interfere with the assessment of efficacy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to assess the efficacy of Gaviscon Advance (an aniseed flavoured oral suspension) compared with placebo in the suppression of GORD symptoms in patients whose symptoms are inadequately controlled by once daily PPI therapy alone.;Secondary Objective: Quality of life;Primary end point(s): The primary endpoint is the change in HRDQ scores [heartburn and regurgitation only] (mean over the 7 days of treatment) from baseline (mean over the 7 days of run-in).;Timepoint(s) of evaluation of this end point: Visit 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Change in HRDQ scores [dyspepsia only] (mean over the 7 days of treatment) from baseline (mean over the 7 days of run-in). • Change in number of days with night-time symptoms (mean over the 7 days of treatment) from baseline (mean over the 7 days of run-in). • Change in whether the patient has any night-time symptoms (over the 7 days of treatment) from baseline (over the 7 days of run-in). • Change in duration of symptoms [taken from HRDQ] (mean over the 7 days of treatment) from baseline (mean over the 7 days of run-in). • Change in frequency of individual symptoms (heartburn, regurgitation, dyspepsia [taken from HRDQ]) (mean over the 7 days of treatment) from baseline (mean over the 7 days of run-in). • Change in ReQuest™ GI Scores [short version only] (mean over the 7 days of treatment) from baseline (mean over the 7 days of run-in). • Change from baseline in patient satisfaction scores at the end of the study. • The number of symptom-free days (using both HRDQ and ReQuest™ individually) following one week of treatment with study medication, beginning on day 1. • Change in number of symptom-free days (using both HRDQ and ReQuest™ individually) (mean over 7 days of treatment) from baseline (mean over 7 days of run-in).;Timepoint(s) of evaluation of this end point: Visit 3 | — |
Countries
Denmark, Germany
Contacts
Public ContactClinical Project Management
Clearcut Clinical Consulting Ltd.
Outcome results
None listed