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

Phase 1

• Conditions: Gastro-Oesophageal Reflux Disease (GORD); Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

• Registration Number: EUCTR2014-005261-69-DE
• Lead Sponsor: Reckitt Benckiser Healthcare (UK) Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-18
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 493

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 GORD dimension 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

Patients to whom any of the following conditions apply must be excluded:
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 sy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified