Clinical Trials Register

Summary
EudraCT Number:	2016-000539-42
Sponsor's Protocol Code Number:	RB2-NL-1518
National Competent Authority:	Netherlands - Competent Authority
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2016-03-10
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

Netherlands - Competent Authority

A.2

EudraCT number

2016-000539-42

A.3

Full title of the trial

A randomised, single dose, crossover, open label, placebo controlled confirmatory study in healthy volunteers to characterise the acid neutralisation activity of Gaviscon Double Action Liquid in the fasted state, using an intragastric and oesophageal pH catheter.

A.3.1

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

Gaviscon Double Action Liquid pH Monitoring Study

A.3.2

Name or abbreviated title of the trial where available

Acid Neutralisation confirmatory pH monitoring study

A.4.1

Sponsor's protocol code number

RB2-NL-1518

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	Victoria Hodgkinson
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	HU87DS
B.5.3.4	Country	United Kingdom
B.5.4	Telephone number	00441482582241
B.5.6	E-mail	Victoria.Hodgkinson@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 Dual 500 Mg / 213 Mg /325 Mg Suspension Zum einnehmen im Beutel
D.2.1.1.2	Name of the Marketing Authorisation holder	Reckitt Benckiser Healthcare B.V.
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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 Liquid Sachets
D.3.4	Pharmaceutical form	Oral suspension in sachet
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	1000
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	426
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	650
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	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	Oral suspension in sachet
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

To investigate the pH of the acid in the stomach of healthy volunteers after the intakeof Gaviscon Double Action liquid.

E.1.1.1

Medical condition in easily understood language

Study to determine the pH of the acid in the stomach after taking Gaviscon Double Action liquid vs Placebo in healthy volunteers

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 confirmatory study is to confirm the acid neutralisation action of Gaviscon Double Action Liquid versus placebo liquid, within the stomach.

E.2.2

Secondary objectives of the trial

The secondary objective of this study is to assess the safety of the test formulation.

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. Male or female subjects who have given written informed consent.
2. Age: ≥ 18 years ≤ 50 years.
3. Body Mass Index (BMI): ≥ 18.5 and ≤ 24.9 kg/m2.
4. Height ≤ 1.90 metres
5. Healthy as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.

E.4

Principal exclusion criteria

-A history of gastro-oesophageal reflux or active gastrointestinal disease (gastroduodenal ulcer, gastrointestinal haemorrhage, mechanical obstruction or perforation) within the last year.
-Clinically significant diseases of the body system.
-A medical history that is associated with an increased risk in study procedures (e.g. basal skull fracture or those who have undergone trans-sphenoidal surgery).
-Hospitalisation within the previous three months for major surgery or medical illness.
-A clinically significant illness within the 4 weeks prior to screening.
-Ingestion of any prescription medication or non-prescription medication within the seven days, prior to the screening visit, which the Principal Investigator considers may interfere with the study.
-Ingestion of antacids, H2 antagonists, motility stimulants (e.g. prokinetics, macrolide antibiotics such as erythromycin and azithromycin, and 5-hydroxytryptamine [5HT] agonists such as sumatriptan) or other medicines for relief of symptoms of acid reflux disease 2 weeks prior to enrolment in the study and during the study and/or have taken proton pump inhibitors in the 4 weeks prior to enrolment into the study and during the study. Enrolment is defined as the date of informed consent signature.
-Those who are currently taking any of the following medications: antihistamines, tetracyclines, digoxin, quinolones including fluoroquinolone, iron salts, neuroleptics, thyroxine and levothyroxine, penicillamine, beta-blockers (e.g. atenolol, metoprolol, propranolol), glucocorticoid, chloroquine, biphosphonates, ketoconazole, eltrombopag and Thiazide diuretics.
-A history of drug hypersensitivity, which in the opinion of the Principal Investigator might interfere with the study.
-A history of allergy or intolerance to either IMP or the following formulation constituents: e.g. sodium alginate, parabens (methyl and propyl), glucose syrup, carbomer, xanthan gum.
-A current or recent history (within one year of the screening visit) of alcohol abuse or significant abuse/misuse of any legal or illegal drugs, substances and solvents.
-Those with a positive screen/test for drugs of abuse and/or alcohol.
-Those who regularly (weekly) consume excessive amounts of alcohol (> 8 units for men and > 6 units for women in one consumption, excessive amounts as defined by the UK National Office of Statistics).
-Those who have consumed more than 2 units of alcohol per day in the 7 days prior to the screening visit and from the screening visit up to 48 hours before admission to the Clinical Unit for Treatment Period 1.
-Those who have consumed alcohol within the 48 hours before admission to the Clinical Unit for Treatment Period 1 and there is insufficient time for the visit to be rescheduled.
-Those who regularly consume excessive quantities of caffeine (> 6 cups of tea, coffee or cola per day), according to the Investigator’s judgement.
-Those who have consumed caffeine-containing food and drinks within the 48 hours before admission to the Clinical Unit for Treatment Period 1 and there is insufficient time for the visit to be rescheduled.
-Those who are either unable to refrain from using tobacco/nicotine during the study treatment periods or unable to smoke less than 6 cigarettes (or equivalent) per day.
-Those with any clinically significant abnormal laboratory result, in the opinion of the Principal Investigator.
-Known human immune deficiency virus (HIV) positive status, or a positive viral serology screen.
-Female subjects of child bearing potential who are unwilling to use an effective method of contraception unless they are abstaining from sexual intercourse in line with the preferred and usual lifestyle of the subject, for the entire study duration. Effective forms of contraception and the definition of non-child bearing potential for the purpose of this study is defined within section 4.4.
-Male subjects who are not willing to use an effective method of contraception for the entire study duration, unless anatomically sterile or where abstaining from sexual intercourse in line with the preferred and usual lifestyle of the subject (see section 4.4).
-Females who are pregnant or lactating.
-Those who are unable to communicate well with the Investigator (i.e. language or neurodevelopmental disorders) in the opinion of the Investigator.
-Those previously randomised into this study.
-Those who are an employee at the study site.
-Those who are a partner or first-degree relative of the Investigator.
-Those who have participated in a clinical study in the 12 weeks prior to the screening visit.
-Those who have participated in 4 (or more) clinical studies in the 10 months prior to the screening visit.
-Those who have donated more than 1.5 litres of blood in the 10 months prior to the screening visit
-Those who are 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 the mean percentage of time that pH ≥ 4 over 0-30 minutes post-dose across electrodes 5 to 10. The primary analysis will be the comparison of this endpoint between Gaviscon Double Action Liquid and placebo liquid, within

E.5.1.1

Timepoint(s) of evaluation of this end point

Over a minimum of 30 minutes post-dose

E.5.2

Secondary end point(s)

The secondary endpoints are:
• The mean percentage of time that pH ≥ 4 over the interval 30-60 minutes post-dose across electrodes 5 to 10.
• The mean percentage of time that pH ≥ 3 over the intervals 0-30 minutes and 30-60 minutes post-dose across electrodes 5 to 10.
• The mean percentage of time that pH ≥ 3 and pH ≥ 4 over the 10 minute intervals post-dose across electrodes 5 to 10.
• The percentage of time that pH ≥ 3 and pH ≥ 4 over the 10 minute and 30 minute intervals at each electrode.
These endpoints will be compared between Gaviscon Double Action Liquid and placebo.
The following will be displayed non-comparatively:
• The pH value measured every 4 seconds during each monitoring period at each electrode.

Safety endpoints:
• The occurrence of Adverse Events
• The absolute value and change from baseline in each vital sign, ECG parameter and physical examination
• The absolute value and change from baseline in each haematology, biochemistry and urinary test

E.5.2.1

Timepoint(s) of evaluation of this end point

As detailed in E.5.2

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

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

Yes

E.6.13.1

Other scope of the trial description

mechanistic mode of action

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

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

Yes

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

Yes

E.8.4

The trial involves multiple sites in the 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:

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

Yes

F.3.2

Patients

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

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)

Subjects 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.
No other additional care will take place following the end of the study. Study subjects are healthy subjects, so additional care is not appropriate. Should any abnormalities be identified during the endoscopy , then the subject will be referred to their physician for additional examinations and care, if deemed required by the consultant gastroenterologist.

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

2016-03-10

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-04-15

P. End of Trial
P.	End of Trial Status	Completed

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