Clinical Trials Register

Summary
EudraCT Number:	2012-002236-87
Sponsor's Protocol Code Number:	RH01561
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:	2012-06-07
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

2012-002236-87

A.3

Full title of the trial

Clinical Study to Evaluate the Efficacy of Chlorhexidine Mouthwashes

A.3.1

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

Clinical Study to Evaluate the Efficacy of Chlorhexidine Mouthwashes

A.4.1

Sponsor's protocol code number

RH01561

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	GlaxoSmithKline Consumer Healthcare
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	GlaxoSmithKline Consumer Healthcare
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	GlaxoSmithKline Consumer Healthcare
B.5.2	Functional name of contact point	GSK CH Clinical Trials
B.5.3	Address:
B.5.3.1	Street Address	St Georges Avenue
B.5.3.2	Town/ city	Weybridge
B.5.3.3	Post code	KT13 0DE
B.5.3.4	Country	United Kingdom
B.5.4	Telephone number	4401932822350
B.5.5	Fax number	N/AN/AN/A
B.5.6	E-mail	rd.gskch-clinical-trials@gsk.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	Corsodyl Mint Mouthwash
D.2.1.1.2	Name of the Marketing Authorisation holder	Beecham Group Plc trading as GlaxoSmithKline Consumer Healthcare
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	Corsodyl Mint Mouthwash - alcohol containing
D.3.4	Pharmaceutical form	Oromucosal solution
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oromucosal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	18472-51-0
D.3.9.3	Other descriptive name	CHLORHEXIDINE DIGLUCONATE SOLUTION
D.3.9.4	EV Substance Code	SUB11810MIG
D.3.10	Strength
D.3.10.1	Concentration unit	% (W/V) percent weight/volume
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.2
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.IMP: 2
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	Corsodyl 0.2% Mouthwash
D.2.1.1.2	Name of the Marketing Authorisation holder	Beecham Group Plc trading as GlaxoSmithKline Consumer Healthcare
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	Corsodyl Mint Mouthwash - alcohol free
D.3.4	Pharmaceutical form	Oromucosal solution
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oromucosal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	18472-51-0
D.3.9.3	Other descriptive name	CHLORHEXIDINE DIGLUCONATE SOLUTION
D.3.9.4	EV Substance Code	SUB11810MIG
D.3.10	Strength
D.3.10.1	Concentration unit	% (W/V) percent weight/volume
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.2
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Gingival bleeding and gingivitis

E.1.1.1

Medical condition in easily understood language

Gum bleeding and gum inflammation

E.1.1.2

Therapeutic area

Diseases [C] - Mouth and tooth diseases [C07]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	PT
E.1.2	Classification code	10018292
E.1.2	Term	Gingivitis
E.1.2	System Organ Class	10017947 - Gastrointestinal disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	PT
E.1.2	Classification code	10018276
E.1.2	Term	Gingival bleeding
E.1.2	System Organ Class	10017947 - Gastrointestinal disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To evaluate and compare Gingival Bleeding (as assessed by the gingival severity component of the Gingival Index [GI]) following twice daily use of a non-alcohol 0.2% Chlorhexidine mouthrinse and brushing compared to brushing only. Also twice daily use of an alcohol 0.2% Chlorhexidine mouthrinse and brushing compared to brushing only.

E.2.2

Secondary objectives of the trial

To evaluate and compare Gingivitis (as assessed by the Gingival Index) following twice daily use of a non-alcohol 0.2% Chlorhexidine (CHX) mouthrinse and brushing compared to brushing only. Also twice daily use of an alcohol 0.2% Chlorhexidine mouthrinse and brushing compared to brushing only.

To evaluate and compare plaque control (overall and interproximal dental plaque scores) using Turesky modification of Quigley & Hein plaque index following twice daily use of a non-alcohol 0.2% Chlorhexidine mouthrinse and brushing compared to brushing only. Also twice daily use of an alcohol 0.2% Chlorhexidine mouthrinse and brushing compared to brushing only.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Consent

Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.

2. Age

Aged at least 18 years and not over 64 years.

3. Compliance

Understands and is willing, able and likely to comply with all study procedures and restrictions.

4. General Health

Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or oral/ dental examination.

5. Dental Health

a) Good oral health in the opinion of the investigator (allowing mild to moderate gingivitis to meet entry criteria).

b) A minimum of 20 permanent gradable teeth at screening. (Gradable teeth are those where restorative materials cover less than 25% of the tooth surface graded).

c) Mild to moderate gingivitis present at the screening visit in the opinion of the investigator.

d) Positive response to bleeding on brushing exercise at screening visit.

e) A total of 20 bleeding sites or greater at baseline visit.

6. Contraception

Females of childbearing potential who are, in the opinion of the investigator, practising a reliable method of contraception. Adequate contraception is defined as abstinence, oral contraceptive, either combined or progestogen alone OR injectable progestogen OR implants of levonorgestrel OR estrogenic vaginal ring OR percutaneous contraceptive patches OR intrauterine device or intrauterine system OR double barrier method (condom or occlusive cap [diaphragm or cervical vault caps] plus spermicidal agent [foam, gel, film, cream, suppository]) OR male partner sterilization prior to the female subject's entry into the study, and this male is the sole partner for that subject.

E.4

Principal exclusion criteria

1. Pregnancy

Women who are pregnant, intending to become pregnant or who have a positive urine pregnancy test at the screening, baseline or prophylaxis visits.

2. Breast-feeding

Women who are breast–feeding.

3. Allergy/Intolerance

Known or suspected intolerance or hypersensitivity to Chlorhexidine or other study materials (or closely related compounds) or any of their stated ingredients.

4. Clinical Study/Experimental Medication

a) Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.

b) Previous participation in this study.

5. Medical History/ Current Medications

a) Current or relevant history of any serious, severe or unstable physical or psychiatric illness or any other medical condition (e.g. Diabetes Mellitus) that would make the subject unlikely to fully complete the study or any that increases the risk to the subject or undermines the data validity.

b) Subjects requiring prophylactic antibiotic treatment prior to dental therapy.

c) Use of concomitant medication that, in the opinion of the investigator, might interfere with the outcome of the study or increases the risk to the subject (eg: phenytoin, calcium antagonists, cyclosporine, warfarin, antibiotics, immuno-suppressants).

d) Use of antibiotics within two weeks prior to the screening visit or throughout the study.

e) Use of any systemic medication which would have an effect on gingival conditions within 14 days of gingival examinations (eg: ibuprofen or aspirin therapy)

6. Dental Health

a) Have current active caries

b) More than 3 pockets with 5mm or over.

c) Excessive calculus present that interferes with the probing examination for Gingival Index.

d) Other severe oral/ gingival conditions (e.g. Acute Necrotizing Ulcerative Gingivitis) that may compromise the study or the subjects in the opinion of the investigator or gingivitis examiner.

e) Medical conditions which may directly influence gingival bleeding.

f) Restorations in a poor state of repair.

g) Orthodontic appliances anterior cosmetic restorations and veneers.

h) Enamel pitting/irregularities.

7. Tobacco Chewers

Subjects using chewing tobacco, pan, pan-masala, gutkha or other chewing tobacco products or subjects who have quit using any of those within the past six months prior to screening.

8. Substance abuse

Recent history (within the last year) of alcohol or other substance abuse.

9. Personnel

a) An employee of the sponsor or the study site or members or their immediate family.

b) An employee of any toothpaste manufacturer or their immediate family.

E.5 End points

E.5.1

Primary end point(s)

Gingival Severity Index (a component of the Gingival Index assessing the proportion of bleeding sites)

E.5.1.1

Timepoint(s) of evaluation of this end point

6 weeks

E.5.2

Secondary end point(s)

-Gingival index score

- Overall plaque score (Turesky Modification of the Quigley Hein Index)

- Interproximal plaque score (Turesky Modification of the Quigley Hein Index)

E.5.2.1

Timepoint(s) of evaluation of this end point

6 weeks

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)

E.7.4

Therapeutic use (Phase IV)

Yes

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

Yes

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

Stratified

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Toothbrushing with a sodium fluoride toothpaste

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 plus 5 days for follow up of adverse events

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:

360

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

360

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)

On conclusion of the study, subjects will be offered a dental prophylaxis by a dental professional to remove stain that may have accumulated during the course of the study.

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

2012-06-18

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-08-16

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2013-03-01

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