Clinical Trials Register

Summary
EudraCT Number:	2012-004470-25
Sponsor's Protocol Code Number:	GA1214
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:	2012-11-12
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

2012-004470-25

A.3

Full title of the trial

A multicentre, randomised, double-blind, two arm, parallel group, pilot study to assess the effect of Gaviscon® Double Action Mint 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

Gaviscon® Double Action Mint as add-on therapy in GORD patients with inadequate response to PPI treatment

A.3.2

Name or abbreviated title of the trial where available

Gaviscon® Double Action Mint as add-on therapy in GORD patients with inadequate response to PPI's

A.4.1

Sponsor's protocol code number

GA1214

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
B.5.2	Functional name of contact point

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 Mint
D.2.1.1.2	Name of the Marketing Authorisation holder	Reckitt Benckiser
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 Mint
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.3.9.1	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	ml millilitre(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.3.9.1	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	ml millilitre(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.3.9.1	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	ml millilitre(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	750
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	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

Patients with Gastro Oesophageal Reflux Disease (GORD) with inadequate response to PPI treatment

E.1.1.1

Medical condition in easily understood language

Gastro Oesophageal Reflux Disease (GORD) patients with inadequate response to PPI treatment

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 Mint compared with Matched Placebo Liquid 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

The secondary objectives of this pilot study are to assess the efficacy of Gaviscon® Double Action Mint compared with Matched Placebo Liquid in change in duration, frequency and timing of the symptoms of heartburn, acid regurgitation and dyspepsia in patients with GORD whose symptoms are inadequately controlled by once daily PPI therapy alone. Other secondary objectives include the efficacy of Gaviscon® Double Action Mint compared with Matched Placebo Liquid in subject satisfaction.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Informed consent has been obtained.
2. Age: ≥ 18 years.
3. Sex: male or female.
4. Current evidence of symptomatic GORD in accord with the Montreal definition following treatment with a proton pump inhibitor. This evidence can be based solely on symptom characteristics.
5. Patients must have had troublesome heartburn or regurgitation of at least mild or moderate intensity* on at least three days a week during the two weeks before the start of screening. If the patient also has other symptoms, the heartburn or regurgitation must be the predominant symptoms.
*Symptom intensity should be assessed using the following scale;
• Mild: awareness of symptom but easily tolerated
• Moderate: discomforting symptom sufficient to cause interference with normal activities including sleep
• Severe: incapacitating symptom with inability to perform normal activities, including sleep
6. Treatment with once daily PPI for at least the previous 4 weeks at standard doses, eg, lansoprazole 30 mg per day, omeprazole 10 to 40 mg per day, pantoprazole 20 to 40 mg per day.
7. Compliance regarding use of prescribed once-daily PPI over 4 weeks, as determined by the investigator.
8. Status: subjects will be members of the public who respond to an advertisement or letter from the site.

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 mild or 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 on three occasions per 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 (diagnostically confirmed), peptic ulcer disease, Zollinger-Ellison syndrome, systemic sclerosis, hiatus hernia (diagnostically confirmed), recent (with last year) upper gastrointestinal endoscopy examination that has shown LA grade C or D oesophagitis.
2. A recent history of drug, solvent or alcohol abuse (weekly alcohol intake ≥ 140g or 17.5 units).
3. Recent cardiac chest pain.
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. Non-steroidal anti-inflammatory drugs or other analgesics in doses that might compromise symptom recording.
7. Patients who have taken any of the following treatments in the week prior to the screening visit (Visit 1) and who may require any of these during the study (as they are also excluded throughout the study):
H2-receptor antagonists
Mucous membrane protection drugs
Anti-cholinesterase drugs, sucralfate or misoprostol preparations
Antacids (including Gaviscon)
8. Current enrolment in another study or involvement in a previous symptom relief Gaviscon study in the past year.
9. Previous surgery of the oesophagus, stomach or duodenum.
10. Potential language problems in understanding information and recording symptoms.
11. 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.
12. Female subjects of childbearing potential who, for the duration of the study, are either unwilling or unable to take adequate contraceptive precautions or are unwilling to be sexually abstinent (as defined in Section 10.44).
13. Pregnancy or lactating mother.
14. Subjects with known hypophosphataemia, phenylketonuria or hypercalcaemia
15. Subjects with severe/impaired renal function or insufficiency
16. Any previous history of allergy or known intolerance to any of the Investigational medicinal product’s (IMP) or following formulation constituents: e.g. sodium alginate, parabens (methyl and propyl), glucose syrup, carbomer and xanthan gum.
17. Previously randomised into the study.
18. Employee at study site.
19. Partner or first-degree relative of the Investigator.
20. Participation in a clinical study in the previous 3 months
21. 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 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 2 and Visit 3

E.5.2

Secondary end point(s)

The following will be compared between treatments:
• 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 2 and 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

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

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)

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

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)

No other additional care of study subjects will take place following the end of the study. The treatment of the subject’s condition will follow normal clinical practice.
AEs starting after the end of the study will not be followed up. All suspected adverse reactions reported post-study will be processed in accordance with RB's pharmacovigilance procedures.

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

2012-12-14

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-01-08

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2013-08-23

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