Clinical Trials Register

Summary
EudraCT Number:	2011-005486-21
Sponsor's Protocol Code Number:	GA1102
National Competent Authority:	Denmark - DHMA
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2012-01-26
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

Denmark - DHMA

A.2

EudraCT number

2011-005486-21

A.3

Full title of the trial

A multicentre, randomised, double-blind, two arm, parallel group,
placebo controlled, pilot study to assess the effect of Gaviscon
Advance as add-on therapy in GORD patients with inadequate
response to once daily proton pump inhibitor treatment.

A.3.1

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

Study to assess the effect of Gaviscon Advance as add-on therapy in GORD patients with inadequate response to once daily proton pump inhibitor treatment.

A.4.1

Sponsor's protocol code number

GA1102

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
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	Clearcut Clinical Consulting Ltd.
B.5.2	Functional name of contact point	Clinical Project Management
B.5.3	Address:
B.5.3.1	Street Address	37 Wollaton Vale
B.5.3.2	Town/ city	Nottingham
B.5.3.3	Post code	NG8 2PD
B.5.3.4	Country	United Kingdom
B.5.4	Telephone number	+447813731925
B.5.5	Fax number	+447813731925
B.5.6	E-mail	sandie.reader@clearcutclinical.co.uk

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 Advance
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 Advance
D.3.2	Product code	Gaviscon Advance Oral suspension
D.3.4	Pharmaceutical form	Oral suspension
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	POTASSIUM BICARBONATE
D.3.9.1	CAS number	298-14-6
D.3.9.2	Current sponsor code	Gaviscon Advance
D.3.9.3	Other descriptive name	POTASSIUM BICARBONATE
D.3.9.4	EV Substance Code	SUB14967MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/l milligram(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	20
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.3.9.2	Current sponsor code	Gaviscon Advance
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/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
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	Yes
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
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

Heartburn and acid regurgitation

E.1.1.2

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	15.1
E.1.2	Level	LLT
E.1.2	Classification code	10066874
E.1.2	Term	Gastroesophageal reflux disease
E.1.2	System Organ Class	100000004856

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 the study is to assess the efficacy of Gaviscon Advance (an aniseed flavoured oral suspension) compared with placebo in the suppression of GORD symptoms in patients whose symptoms are inadequately controlled by once daily PPI therapy alone.

E.2.2

Secondary objectives of the trial

Quality of life

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1) Male or female patients aged at least 18 years.
2) Evidence of symptomatic GORD, despite current treatment with the optimum individualized dose of a once daily proton pump inhibitor. GORD symptoms should be such that the Investigator believes it is likely that the patient will achieve a score of 18 during one week of treatment with a PPI before
randomization (as described in Section 10.3: Additional Inclusion Criteria for Randomisation, number 2).
3) Treatment with once daily PPI for at least the previous 4 weeks.
4) Compliance regarding use of prescribed once-daily PPI over 4 weeks, as determined by the investigator.
5) Provision of written informed consent.

Additional Inclusion Criteria for Randomisation
Following the 7-day run in period, patients will be assessed against the following inclusion criteria before randomisation.
1) Completion of the run-in diary card and questionnaires on each of the seven days of the run-in period.
2) At least one reflux symptom (heartburn or regurgitation) of at least moderate intensity measured during the 7-day run-in period (from the HRDQ questionnaire) and a summarised 7-day score of at least 18 (e.g. corresponding to 3 days with moderate heartburn 3 times a day). (The daily score will be calculated as intensity x frequency, where intensity is scored as 0 = none, 1 = mild, 2 =
moderate and 3 = severe and frequency is scored as 0 = none, 1 = once, 2 = twice, 3 = thrice, 4 = 4 or 5 times, 5 = 6 – 10 times and 6 = more than 10 times or constant).
3) Compliance with PPI treatment (once daily in the morning) on all seven days of the run-in period.

E.4

Principal exclusion criteria

1) Oesophageal stricture, peptic ulcer disease, Zollinger-Ellison syndrome, systemic sclerosis, recent upper gastrointestinal endoscopy examination that has shown LA grade C or D oesophagitis.
2) Drug, solvent or alcohol abuse (weekly alcohol intake ≥ 140g) within the 3 months before screening.
3) Cardiac chest pain within the 3 months before screening.
4) Recent, significant unexplained weight loss of greater than 6 kg in the last 6 months.
5) Gastro-intestinal bleeding (hematochezia or hematemesis) within the last 3 months.
6) Allergy or known intolerance to any of the study drug excipients: carbomer, methyl parahydroxybenzoate, propyl parahydroxybenzoate, saccharin sodium, fennel flavour and sodium hydroxide, or the following formulation constituents:
sodium alginate, calcium carbonate, potassium bicarbonate, methyl titanium dioxide and xanthan gum.
7) Use of antidepressants, non-steroidal anti-inflammatory drugs or other analgesics that might, in the opinion of the investigator, compromise symptom recording.
8) Current enrollment in another study or involvement in a previous symptom relief Gaviscon study.
9) Previous surgery of the oesophagus, stomach or duodenum.
10) History of hypercalcaemia or nephrocalcinosis.
11) Potential language problems in understanding information and recording symptoms.
12) Pregnancy or breast feeding.
13) Any co-existing condition which, in the opinion of the investigator, would be likely to compromise patient safety or interfere with the assessment of efficacy.

E.5 End points

E.5.1

Primary end point(s)

The primary endpoint is the change in HRDQ scores [heartburn and regurgitation only] (mean over the 7 days of treatment) from baseline (mean over the 7 days of run-in).

E.5.1.1

Timepoint(s) of evaluation of this end point

Visit 3

E.5.2

Secondary end point(s)

• Change in HRDQ scores [dyspepsia only] (mean over the 7 days of treatment) from baseline (mean over the 7 days of run-in).
• Change in number of days with night-time symptoms (mean over the 7 days of treatment) from baseline (mean over the 7 days of run-in).
• Change in whether the patient has any night-time symptoms (over the 7 days of treatment) from baseline (over the 7 days of run-in).
• Change in duration of symptoms [taken from HRDQ] (mean over the 7 days of treatment) from baseline (mean over the 7 days of run-in).
• Change in frequency of individual symptoms (heartburn, regurgitation, dyspepsia [taken from HRDQ]) (mean over the 7 days of treatment) from baseline (mean over the 7 days of run-in).
• Change in ReQuest™ GI Scores [short version only] (mean over the 7 days of treatment) from baseline (mean over the 7 days of run-in).
• Change from baseline in patient satisfaction scores at the end of the study.
• The number of symptom-free days (using both HRDQ and ReQuest™ individually) following one week of treatment with study medication, beginning on day 1.
• Change in number of symptom-free days (using both HRDQ and ReQuest™ individually) (mean over 7 days of treatment) from baseline (mean over 7 days of run-in).

E.5.2.1

Timepoint(s) of evaluation of this end point

Visit 3

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

Yes

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:

135

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2012-01-26.

Yes

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

150

F.4.2

For a multinational trial

F.4.2.1

In the EEA

150

F.4.2.2

In the whole clinical trial

150

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)

No other additional care of study patients will take place following completion 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

2012-01-26

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-12-08

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2013-11-14

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