Sodium Alginate Chewable Tablet European Symptom Relief Study for patients with symptoms of GORD

Phase 1

Conditions: Gastro-Oesophageal Reflux Disease (GORD)
MedDRA version: 20.1Level: LLTClassification code 10018203Term: GERDSystem Organ Class: 100000004856
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: EUCTR2014-005261-69-IT

Lead Sponsor: RECKITT BENCKISER HEALTHCARE (UK) LIMITED

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 424

Inclusion Criteria

1. Informed consent has been freely given.
2. Males and females = 18 years.
3. Primary diagnosis: Current documented evidence of symptomatic
GORD in accordance with the Montreal definition. This evidence can be
based solely on symptom characteristics. Patients must have
experienced frequent troublesome heartburn and / or regurgitation
(with or without dyspepsia symptoms) of at least moderate intensity*
during the last 3 months and also on at least five days during the week
before the start of screening. If the patient also has other symptoms, the
heartburn, regurgitation or dyspepsia should be the predominant
symptoms.
*Symptom intensity should be assessed using the following scale:
I. Mild: awareness of symptom but easily tolerated
II. Moderate: discomforting symptom sufficient to cause interference
with normal activities including sleep
III. Severe: incapacitating symptom with inability to perform normal
activities, including sleep
4. At Visit 2, all 12 items of the RDQ are to be completed with a minimum
score of 1.5 for heartburn recorded.
5. Status: Patients may be referred from either their General Practitioner
(GP) / consultant or by attending the investigational site, without GP
referral, in response to an advertisement to join this clinical study. In
addition patients may be recruited by the clinic from hospital databases
or out-patient clinics.
6. Patients must be sufficiently literate to be able to complete the RDQ
unaided.
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 329
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 164

Exclusion Criteria

1.Those who have a current or recent (within one year) history of
alcohol abuse or abuse of any legal or illegal drugs, substances or
solvents.
2. Patients with a history and / or symptom profile indicative of severe diseases of major body systems.
3. Patients either with any co-existing condition which, in the opinion of the Investigator, would be likely to compromise patient safety or
interfere with assessment of efficacy;
or with any clinically significant abnormal laboratory values.
4. Patients presenting with a history of psychiatric diagnosis according to Chapter V International Statistical Classification of Diseases and
Related Health Problems 10th Revision (ICD-10)-2015-WHO.
5. Presence of clinically significant abnormalities in the physical examination, endoscopy, ECG, vital signs, and laboratory safety results.
6. Patients who have suffered cardiac chest pain within the last year.
7. Patients with documented damaged heart or severe / impaired kidney function or insufficiency and patients who require a low sodium diet.
8. Patients with known hypophosphataemia, phenylketonuria or hypercalcaemia.
9. Patients who have suffered a recent, significant, unexplained weight loss of more than 7 Kg in the last 6 months.
10. Those with difficulty swallowing (dysphagia), gastrointestinal (GI) bleeding, or other symptoms suggestive of neoplastic or severe inflammatory disease within the 12 months before screening (Visit 1).
11. Patients with a history (within the last 3 months) and / or symptom profile suggestive of and / or discovered on endoscopy of the following:
i. Gastric or duodenal erosions
ii. Duodenitis
iii. Polyps larger than 0.5 cm, or those clinically significant in the opinion
of the Investigator
iv. Erosive GORD (Los Angeles [LA] classification grades C-D)
v. Barrett's oesophagus
vi. Acute peptic ulcer and / or ulcer complications
vii. Zollinger-Ellison syndrome
viii. Gastric carcinoma
ix. Pyloric stenosis
x. Patients who were observed on endoscopy to have a hiatus hernia
with a diameter which exceeds 3cm
xi. Any other clinically significant gastrointestinal disease
12. Oesophageal or gastric surgery, intestinal obstruction.
13. Current pernicious anaemia.
14. Known Indication for H-pylori eradication therapy.
15. Known gastro-intestinal bleeding (haematochezia or haematemesis).
16. Those with a history of upper GI surgery or endoscopic interventions
such as oesophageal dilatations or mucosal resection.
17. Patients with severe constipation.
18. Any previous history of allergy or known intolerance to 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.
19. Patients who have taken any of the below prohibited medications (in
the periods specified below), and those not willing / unable to withhold
them throughout the study:
i. Macrolide antibiotics (e.g. erythromycin and azithromycin) within 24
hours before screening (Visit 1)
ii. Antacids and alginate preparations within 24 hours before
randomisation
(Visit 2)
iii. Patients who have taken Proton Pump Inhibitors (PPIs) within the 10
days prior to randomisation (Visit 2), prokinetics or H2 antagonists
within the 5 days prior to randomisation (Visit 2) or systemic
glucocorticosteroids or antiinflammatory drugs on more than 3
consecutive days or PPI-based triple the

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

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