Sodium alginate liquid suspension as add-on therapy in GORD patients with inadequate response to PPI treatment – a pivotal study.
- Conditions
- Gastro-Oesophageal Reflux Disease (GORD)Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
- Registration Number
- EUCTR2014-003174-17-GB
- Lead Sponsor
- Reckitt Benckiser Healthcare (UK) Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 396
1. Informed consent has been obtained.
2. Age: Minimum 18 years
3. Sex: male or female.
4. Current evidence of symptomatic GORD in accordance with the Montreal definition(5) following treatment with a proton pump inhibitor (as specified in inclusion criteria #6). This evidence can be based solely on symptom characteristics but in the opinion of the Investigator the symptoms are not related to conditions such as irritable bowel syndrome, gall bladder disease or other such conditions that may present themselves as heartburn or regurgitation.
5. Patients must have had troublesome heartburn or regurgitation of at least mild or moderate intensity* on at least 3 days a week during the 2 weeks before the start of screening. If the patient also has other symptoms, the heartburn or regurgitation must be the predominant symptoms.
*Symptom intensity should be assessed using the following scale:
a. Mild: Awareness of symptom but easily tolerated.
b. Moderate: Discomforting symptom sufficient to cause interference with normal activities including sleep.
c. Severe: Incapacitating symptom with inability to perform normal activities, including sleep.
6. Prescribed treatment with once-daily (before breakfast) PPI for at least the previous 4 weeks at stable standard approved doses, e.g. lansoprazole 30 mg per day, omeprazole 10 to 40 mg per day, pantoprazole 20 to 40 mg per day, 40 mg esomeprazole per day.
7. Compliance regarding use of prescribed once-daily PPI over 4 weeks, as determined by the Investigator.
Following the 7-day run-in period, patients will be assessed against the following inclusion criteria before randomisation.
8.Completion of the run-in diary card and questionnaires on each of the 7 days of the run-in period.
9.At least 3 days during the 7-day run-in period with a HRDQ score [Heartburn and Regurgitation] >0.7.
10.Compliance with PPI treatment (once daily in the morning) on all 7 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 272
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 272
Patients to whom any of the following conditions apply must be excluded:
1.Oesophageal stricture (diagnostically confirmed), peptic ulcer disease, Zollinger-Ellison syndrome, systemic sclerosis, recent (within the last year) upper gastrointestinal endoscopy examination that has shown LA grade C or D oesophagitis.
2.A recent (previous 3 months) history of drug, solvent or alcohol abuse (weekly alcohol intake =140 g or 17.5 units).
3.Recent (previous 3 months) cardiac chest pain.
4.Recent (previous 6 months) significant unexplained weight loss of >6 kg in the last 6 months
5.Gastrointestinal bleeding (lower GI bleeding or haematemesis) within the last 3 months.
6.Patients who have taken non-steroidal anti-inflammatory drugs (NSAIDs, except for low dose aspirin which can be given for cardioprotection) for more than 3 consecutive days in the 28 days prior to screening
7.Patients who have taken any of the following treatments in the week prior to the screening visit (Visit 1) and who may require any of these during the study (as they are also excluded throughout the study):
a.H2-receptor antagonists
b.Anti-cholinesterase drugs, sucralfate or misoprostol preparations
c.Antacids (including Gaviscon).
8.Patients taking or needing to take macrolide antibiotics, such as erythromycin, azithromycin, from the day before screening.
9.Current enrolment in another study or involvement in a previous study assessing symptom relief with sodium alginate in the past year.
10.Previous surgery of the oesophagus, stomach or duodenum.
11.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.
12.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 (as defined in Section 10.4).
13.Pregnancy or lactating mother.
14.Patients with known hypophosphataemia, phenylketonuria or hypercalcaemia.
15.Patients with severe/impaired renal function or insufficiency.
16.Any previous history of allergy or known intolerance to any of the Investigational Medicinal Product (IMP) or following formulation constituents: e.g. sodium alginate, parabens (methyl and propyl), hydrogenated glucose syrup (maltitol), carbomer and xanthan gum.
17.Previously randomised into the study.
18.Employee at study site.
19.Partner or first-degree relative of the Investigator.
20.Participation in a clinical study in the previous 3 months.
21.Unable, in the opinion of the Investigator, to comply fully with the study requirements.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method