Gaviscon Double Action Tablets Pilot Efficacy Study
- Conditions
- This pilot study of Gaviscon Double Action Tablets is to be conducted to demonstrate that Gaviscon Double Action Tablets are effective in managing the symptoms of heartburn, acid regurgitation and dyspepsia in patients with GERD.Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
- Registration Number
- EUCTR2012-002188-84-GB
- Lead Sponsor
- Reckitt Benckiser Healthcare (UK) LTD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Only subjects to whom all of the following conditions apply will be included:
1.Informed consent has been obtained.
2.Age: = 18 years.
3.Sex: male or female.
4.GERD status: history of frequent episodes of GERD-related symptoms during the last 3 months and also during the 5 days of the last 7 days prior to study screening.
5.Subjects who have not taken any antacids within 24 hours before randomisation (Visit 2) and be instructed not to take antacids throughout the remainder of the study.
6.Subjects taking mucous membrane protection drugs or motility stimulants may enter the study provided that these are discontinued for at least 3 days before enrolment and throughout the remainder of the study.
7.Absence of relevant abnormalities in the physical examination, ECG and safety analysis.
8.Subjects must be sufficiently literate to be able to complete the RDQ unaided.
9. Status: subjects will be members of the public who respond to an advertisement or via their doctor.
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 140
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 140
Subjects to whom any of the following conditions apply must be excluded:
1)Subjects who have a history of drug, solvent or alcohol abuse (weekly alcohol intake = 140g or 17.5 units).
2)Subjects who have suffered cardiac chest pain within the last year.
3)Subjects who have suffered a recent, significant unexplained weight loss of more than 6 Kg in the last 6 months.
4)Female subjects of childbearing potential who, for the duration of the study, are either unwilling or unable to take adequate contraceptive precautions (as defined in Section 10.3) or are unwilling to be sexually abstinent.
5)Pregnancy or lactating mother.
6)Subjects with a history and/or symptom profile suggestive of the following: any other gastrointestinal (GI) disease, erosive GERD (Los Angeles [LA] classification grades A-D), Barrett’s oesophagus, acute peptic ulcer and/or ulcer complications, Zollinger-Ellison syndrome, gastric carcinoma, pyloric stenosis, oesophageal or gastric surgery, intestinal obstruction, current pernicious anaemia, indication for H-pylori eradiation therapy, requirement for low sodium diet, known gastro-intestinal bleeding (hematochezia or hematemesis) within the last 3 months, and severe diseases of other major body systems.
7)Subjects who have taken PPIs during the 10 days prior to study start, prokinetics or H2 antagonists during the 5 days prior to study start or systemic glucocorticosteroids, anti-inflammatory drugs on more than 3 consecutive days or PPI-based triple therapy for eradication of H-pylori during the last 28 days.
8)Subjects with known hypophosphataemia or phenylketonuria.
9)Subjects with severe constipation, or history of intestinal obstruction.
10)In the opinion of the Investigator, subjects with damaged heart or kidney function and subjects who require a low sodium diet.
11)Subjects either with any co-existing condition which, in the opinion of the Investigator, would be likely to compromise subject safety or interfere with assessment of efficacy; or with any clinically significant abnormal laboratory values; or in the Investigator’s view to unable to comply fully with the study requirements.
12)Subjects with severe/impaired renal function or insufficiency
13)Any previous history of allergy or known intolerance to any of the IMP’s or following formulation constituents: macrogol 20,000, mannitol (E421), copovidone, acesulfame K, aspartame (E951), mint flavour, carmoisine lake (E122), magnesium stearate, xylitol DC (contains carmellose sodium) or the following formulation constituents: sodium alginate, calcium carbonate, sodium bicarbonate.
14)Previously randomised into the study.
15)Employee at study site.
16)Partner or first-degree relative of the Investigator.
17)Participation in a clinical study in the previous 6 months.
18)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 Main Objective: The primary objective of this pilot study is to assess the efficacy of Gaviscon Double Action Tablets compared with placebo in reduction of the overall symptoms of heartburn, acid regurgitation and dyspepsia in patients with GERD.;Secondary Objective: The secondary objectives of this pilot study are to assess the efficacy of Gaviscon Double Action Tablets compared with placebo in reduction of the symptoms of heartburn, acid regurgitation and dyspepsia in patients with GERD. Other secondary objectives include the efficacy of Gaviscon Double Action Tablets compared with placebo in subject responsiveness / satisfaction and comparison of safety in terms of adverse events.;Primary end point(s): The primary study endpoint is to compare the change from baseline in RDQ symptom scores (for heartburn, regurgitation and dyspepsia) after a 7-day treatment period of a regimen of two Gaviscon Double Action Tablets taken four times daily compared with placebo.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): The secondary endpoints will compare between the two cohorts (Gaviscon Double Action Tablets and placebo) for a 7-days treatment period for the following parameters:<br>•OTE as a measure for subject’s responsiveness/satisfaction<br>•Change from baseline in RDQ scores for heartburn dimension.<br>•Change from baseline in RDQ scores for regurgitation dimension.<br>•Change from baseline in RDQ scores for dyspepsia dimension.<br>