Gaviscon® Double Action Mint as add-on therapy in GORD patients with inadequate response to PPI treatment

Active, not recruiting

• Conditions: Patients with Gastro Oesophageal Reflux Disease (GORD) with inadequate response to PPI treatment; Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

• Registration Number: EUCTR2012-004470-25-GB
• Lead Sponsor: Reckitt Benckiser Healthcare (UK) Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11-12
• Last Update Posted: 10 March 2014

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Informed consent has been obtained.
2.Age: = 18 years.
3.Sex: male or female.
4.Current evidence of symptomatic GORD in accord with the Montreal definition following treatment with a proton pump inhibitor. This evidence can be based solely on symptom characteristics.
5.Patients must have had troublesome heartburn or regurgitation of at least mild or moderate intensity* on at least three days a week during the two 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;
•Mild: awareness of symptom but easily tolerated
•Moderate: discomforting symptom sufficient to cause interference with normal activities including sleep
•Severe: incapacitating symptom with inability to perform normal activities, including sleep
6.Treatment with once daily PPI for at least the previous 4 weeks at standard doses, eg, lansoprazole 30 mg per day, omeprazole 10 to 40 mg per day, pantoprazole 20 to 40 mg per day.
7.Compliance regarding use of prescribed once-daily PPI over 4 weeks, as determined by the investigator.
8.Status: subjects will be members of the public who respond to an advertisement or letter from the site.

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 mild or 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 on three occasions per 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 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

1.Oesophageal stricture (diagnostically confirmed), peptic ulcer disease, Zollinger-Ellison syndrome, systemic sclerosis, hiatus hernia (diagnostically confirmed), recent (with last year) upper gastrointestinal endoscopy examination that has shown LA grade C or D oesophagitis.
2.A recent history of drug, solvent or alcohol abuse (weekly alcohol intake = 140g or 17.5 units).
3.Recent cardiac chest pain.
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.Non-steroidal anti-inflammatory drugs or other analgesics in doses that might compromise symptom recording.
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):
H2-receptor antagonists
Mucous membrane protection drugs
Anti-cholinesterase drugs, sucralfate or misoprostol preparations
Antacids (including Gaviscon)
8.Current enrolment in another study or involvement in a previous symptom relief Gaviscon study in the past year.
9.Previous surgery of the oesophagus, stomach or duodenum.
10.Potential language problems in understanding information and recording symptoms.
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 subjects 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 10.44).
13.Pregnancy or lactating mother.
14.Subjects with known hypophosphataemia, phenylketonuria or hypercalcaemia
15.Subjects with severe/impaired renal function or insufficiency
16.Any previous history of allergy or known intolerance to any of the Investigational medicinal product’s (IMP) or following formulation constituents: e.g. sodium alginate, parabens (methyl and propyl), glucose syrup, 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