Clinical Trials Register

Summary
EudraCT Number:	2012-002188-84
Sponsor's Protocol Code Number:	GA1203
National Competent Authority:	UK - MHRA
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2012-06-22
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

UK - MHRA

A.2

EudraCT number

2012-002188-84

A.3

Full title of the trial

A multi-centred, randomised, double-blind, two arm, parallel group, placebo-controlled, pilot study to assess the effect of Gaviscon Double Action Tablets in patients with reflux disease

A.3.1

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

Gaviscon Double Action Tablets Pilot Efficacy Study

A.3.2

Name or abbreviated title of the trial where available

Gaviscon Double Action Tablets Pilot Efficacy Study

A.4.1

Sponsor's protocol code number

GA1203

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) LTD
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) LTD
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) LTD
B.5.2	Functional name of contact point	Clinical Project Manager
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.5.4	Telephone number	4401482583966
B.5.5	Fax number	4401482582172
B.5.6	E-mail	nigel.levinson.contractor@rb.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Comparator
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) LTD
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.3.9.1	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	500
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	144-55-8
D.3.9.3	Other descriptive name	SODIUM BICARBONATE
D.3.9.4	EV Substance Code	SUB12643MIG
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	213
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
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	375
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

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.

E.1.1.1

Medical condition in easily understood language

A study to demonstate that Gaviscon Double Action Tablets are effective in managing the symptoms of Gastro-oesophageal reflux disease (GERD)

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 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.

E.2.2

Secondary objectives of the trial

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.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

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.

E.4

Principal exclusion criteria

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.

E.5 End points

E.5.1

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.

E.5.2

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:
• OTE as a measure for subject’s responsiveness/satisfaction
• Change from baseline in RDQ scores for heartburn dimension.
• Change from baseline in RDQ scores for regurgitation dimension.
• Change from baseline in RDQ scores for dyspepsia dimension.

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

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

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:

140

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

140

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

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

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

140

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)

The subject will complete the RDQ questionnaire and answer questions relating to overall satisfaction with the trial therapy (OTE) over the previous seven days. Vital signs, adverse events and a physical examination including biochemistry and haematology tests will be assessed.

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

2012-07-27

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-07-17

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2012-10-30

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