Clinical Trials Register

Summary
EudraCT Number:	2014-005261-69
Sponsor's Protocol Code Number:	GA1402
National Competent Authority:	Germany - BfArM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2015-05-18
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Germany - BfArM

A.2

EudraCT number

2014-005261-69

A.3

Full title of the trial

A multi-centre, randomised, double-blind, two arm, parallel group, placebo-controlled study to assess the effect of Sodium Alginate Chewable Tablets on symptoms of gastro-oesophageal reflux disease.

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

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

A.3.2

Name or abbreviated title of the trial where available

Sodium Alginate Chewable Tablet European Symptom Relief Study

A.4.1

Sponsor's protocol code number

GA1402

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Reckitt Benckiser Healthcare (UK) Limited
B.1.3.4	Country	United Kingdom
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Reckitt Benckiser Healthcare (UK) Limited
B.4.2	Country	United Kingdom
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Reckitt Benckiser Healthcare (UK) Limited
B.5.2	Functional name of contact point	Study Specific Mailbox
B.5.3	Address:
B.5.3.1	Street Address	Dansom Lane
B.5.3.2	Town/ city	Hull
B.5.3.3	Post code	HU8 7DS
B.5.3.4	Country	United Kingdom
B.5.6	E-mail	GA1402@rb.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Gaviscon Double Action Tablets
D.2.1.1.2	Name of the Marketing Authorisation holder	Reckitt Benckiser Healthcare (UK) Limited
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Gaviscon Double Action Tablets
D.3.4	Pharmaceutical form	Chewable tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	SODIUM ALGINATE
D.3.9.1	CAS number	9005-38-3
D.3.9.3	Other descriptive name	SODIUM ALGINATE
D.3.9.4	EV Substance Code	SUB15270MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	250
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	SODIUM HYDROGEN CARBONATE
D.3.9.1	CAS number	144-55-8
D.3.9.3	Other descriptive name	SODIUM HYDROGEN CARBONATE
D.3.9.4	EV Substance Code	SUB12290MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	106.5
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	CALCIUM CARBONATE
D.3.9.1	CAS number	471-34-1
D.3.9.3	Other descriptive name	CALCIUM CARBONATE
D.3.9.4	EV Substance Code	SUB13166MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	187.5
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Chewable tablet
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Gastro-Oesophageal Reflux Disease (GORD)

E.1.1.1

Medical condition in easily understood language

Gastro-Oesophageal Reflux Disease (GORD)

E.1.1.2

Therapeutic area

Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The primary objective of this study is to assess the efficacy of Sodium Alginate Chewable Tablets compared to matched placebo tablets in the reduction of the symptoms of GORD as assessed using the Reflux Disease Questionnaire (RDQ).

E.2.2

Secondary objectives of the trial

The secondary objectives of this study are:
- to assess the efficacy of Sodium Alginate Chewable Tablets compared to matched placebo tablets in the reduction of dyspepsia in patients with GORD as assessed using the dyspepsia dimension of the RDQ.
- to assess the efficacy of Sodium Alginate Chewable Tablets compared to matched placebo tablets as measured by patient satisfaction
- Safety and tolerability evaluation based on assessment of adverse events, vital signs and Electrocardiogram (ECG).

E.2.3

Trial contains a sub-study

E.3

Principal 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.

E.4

Principal 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 systemic glucocorticosteroids or antiinflammatory drugs on more than 3 consecutive days or PPI-based triple therapy for eradication of H-pylori within the 28 days prior to screening (Visit 1)
iv. Anticholinesterase drugs, traditional Chinese medicine for treatment of GI diseases / symptoms, ulcermon, sucralfate or misoprostol agents within the 7 days before screening (Visit 1)
v. Mucous membrane protection drugs or prokinetics within the 5 days prior to screening (Visit 1)
vi. Systemic glucocorticosteroids or non-steroidal anti-inflammatory drugs (NSAIDs, except for low dose aspirin which can be given for cardioprotection) for more than 3 consecutive days within the 28 days prior to screening (Visit 1)
20. Female patients 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.
21. Pregnancy or lactating mother.
22. Employee at study site or partner or first-degree relative of the Investigator.
23. Participation in a clinical study in the previous 3 months, including participation in non-interventional clinical studies.
24. Patients who fail the screening, or patients previously randomised into the study, are not allowed to screen for, or be randomised in, the study again.
25. Unable in the opinion of the Investigator to comply fully with the study requirements.

E.5 End points

E.5.1

Primary end point(s)

The primary endpoint will be whether the patient achieves a reduction of at least 1.5 in the RDQ GORD dimension between baseline and the end of the treatment period.
This will be compared between the Sodium Alginate Chewable Tablets and Matched Placebo Tablets.

E.5.1.1

Timepoint(s) of evaluation of this end point

Baseline vs Treatment period

E.5.2

Secondary end point(s)

The difference between test and placebo in:
- Change from baseline at the end of the treatment period in the RDQ dyspepsia
dimension score (all patients)
- Patient rating of the magnitude of change in symptoms from the Overall Treatment Evaluation (OTE) at the end of the treatment period. Patient rating of the importance of the change in symptoms from the Overall Treatment Evaluation (OTE) at the end
of the treatment period
- Change from baseline at the end of the treatment period in the RDQ GORD
dimension score
- Change from baseline at the end of the treatment period in each RDQ question
- Change from baseline at the end of the treatment period in the RDQ heartburn
dimension score
- Change from baseline at the end of the treatment period in the RDQ regurgitation dimension score
- Change from baseline at the end of the treatment period in the RDQ dyspepsia
dimension score (only patients with a baseline RDQ dyspepsia dimension score of at least 1)
- Number of nights when the patient experienced night time symptoms
Safety Endpoints will be assessed as follows:
- Whether patients had an AE (overall, as well as by severity)
- Whether patients had a Treatment Emergent Adverse Event (TEAE) (overall, as well as by severity and relationship to treatment)
- Change in vital signs over the study
- Change in haematology and biochemistry parameters over the study

E.5.2.1

Timepoint(s) of evaluation of this end point

Baseline vs Treatment period

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

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

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

200

F.4.2

For a multinational trial

F.4.2.1

In the EEA

493

F.4.2.2

In the whole clinical trial

493

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

Patients who experience AEs at the end of the study, or experience the onset of an AE after the end of the study, will be followed up as described in sections 13.1.7 and 13.1.8 of the protocol. No other additional care of study patients will take place following the end of the study. The treatment of the patient’s condition will follow normal clinical practice.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2015-06-12

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-08-27

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2016-08-30

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