Clinical Trials Register

Summary
EudraCT Number:	2013-002418-11
Sponsor's Protocol Code Number:	RH01913
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:	2013-06-14
Trial results	Removed from public view

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

2013-002418-11

A.3

Full title of the trial

A study to evaluate the effect of a 67% Sodium Bicarbonate containing toothpaste on Chlorhexidine Digluconate tooth staining

A.3.1

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

A study to evaluate the effect of a 67% Sodium Bicarbonate containing toothpaste on Chlorhexidine Digluconate tooth staining

A.4.1

Sponsor's protocol code number

RH01913

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 George's 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/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 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.3.4	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.3.8	INN - Proposed INN	CHLORHEXIDINE DIGLUCONATE SOLUTION
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

Tooth discolouration (a labelled undesirable effect of Corsodyl 0.2% mouthwash)

E.1.1.1

Medical condition in easily understood language

Tooth discolouration (a labelled undesirable effect of Corsodyl 0.2% mouthwash)

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	10044032
E.1.2	Term	Tooth discolouration
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	10018292
E.1.2	Term	Gingivitis
E.1.2	System Organ Class	10021881 - Infections and infestations

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 determine whether brushing with 67% sodium bicarbonate toothpaste produces a greater level of stain control as indicated by Modified Lobene Stain Index (MLSI) than brushing with non-sodium bicarbonate toothpaste following six weeks usage of 0.2% Corsodyl mouthwash.

E.2.2

Secondary objectives of the trial

To determine whether brushing with 67% sodium bicarbonate toothpaste produces a greater level of stain control than brushing with non-sodium bicarbonate toothpaste following three weeks usage of 0.2% Corsodyl mouthwash as indicated by the MLSI for the overall tooth surfaces.

To compare differences between treatments on stain-control levels after three and six weeks of treatment, as indicated by the MLSI for the, facial, interproximal and interproximal plus gingival tooth surfaces.

To monitor oral Adverse Events (AEs) using Oral Soft Tissue (OST) examinations.

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 18 – 64 years inclusive.

3. Compliance

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

4. General Health

Good general and mental health with, in the opinion of the investigator or medically qualified designee:

a) No clinically significant and relevant abnormalities of medical history or oral examination.
b) Absence of any condition that would impact on the subject’s safety or wellbeing or affect the individual’s ability to understand and follow study procedures and requirements.

5. Contraception

Females of childbearing potential who are, in the opinion of the investigator, practising a reliable method of contraception, for at least three months prior to the start of the study and must not be breast feeding. 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.

6. Oral Health

a) Good oral health in the opinion of the investigator (excluding gingivitis)
b) A minimum of 11 of the 12 permanent gradable anterior teeth at screening. (Gradable teeth are those where restorative materials cover less than 25% of the tooth surface graded).
c) A total of at least 15 bleeding sites or greater at screening visit.
d) Stain levels on the buccal surfaces of the 6 maxillary and 6 mandibular anterior teeth need to be at least “mild” and present on a minimum of 4 teeth (out of the 12 maxillary and mandibular teeth evaluated), as confirmed by gross stain assessment.

7. Modification of the Lobene Stain Index

At Visit 2, a baseline total MLSI Intensity x Area score (four sites per tooth) of greater than or equal to 8 for the facial surfaces (gingival/body/mesial/distal) of anterior teeth numbers 6-11 and facial surfaces of teeth numbers 22-27.

E.4

Principal exclusion criteria

1. Pregnancy

Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.

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. Medication

a) Current use of a Chlorhexidine, Cetylpyridinium Chloride (CPC) or Listerine® Original mouthwash.

b) Past or current use of minocycline, and use of tetracycline or doxycycline or any other drug which is known to be associated with tooth discolouration within 30 days of screening or during the study period.

6. Substance abuse

a) Recent history (within the last 1 year) of alcohol or other substance abuse.
b) Subject unwilling to abstain from using chewing tobacco.

7. Dental History

a) Less than eleven gradable anterior teeth due to surface irregularities, restoration on the facial surfaces, tetracycline stain, discoloration due to trauma, mottling, fluorosis, hyperplasia; hypoplasia or other parameters which make it difficult to measure the extrinsic stain of the teeth consistently.
b) Partial dentures abutted to those teeth to be graded, fixed retainers, fixed or removable orthodontic appliances.
c) Dental conditions / disease requiring immediate treatment.
d) Crowns or veneers on more than one anterior tooth.
e) Pre-existing sensitivity to oral care products.
f) Severe periodontitis.
g) Severe recession.
h) Dental implants.
i) Obvious active carious lesions on anterior teeth.
j) Intra-oral decorative tattoos, or tongue and or lip piercing.
k) Oral lesions/manifestations that would impact on the subject’s inclusion in the study (lichen planus/ large bands of keratinized tissue).
l) Prone to aphthous stomatitis and ulceration (self-reported history of more than 6 months).
m) Presence of oral or peri-oral ulceration including herpetic lesions at the time of screening or at baseline.

8. Condition of Oral Mucosa

Subjects with untreated oral mucosal disease which in the opinion of the investigator could interfere with the study (e.g. current oral ulceration).

9. Medical Conditions

a) Current or relevant history of any serious, severe or unstable physical or psychiatric illness or any medical disorder that would make the subject unlikely to fully complete the study or any condition that presents undue risk from the study treatment or procedures in the opinion of the investigator or dental assessor.
b) Medical condition which would require the use of prophylactic antibiotics prior to dental cleanings.
C) Subject currently undergoing radiotherapy and/or chemotherapy treatment.

10. Personnel

a) An employee of the sponsor or the study site or members of their immediate family.
b) Subject works in one of the following: advertising, journalism, public relations, manufacturing, retail or distribution of medicines, medical devices or healthcare products, market research or marketing.

E.5 End points

E.5.1

Primary end point(s)

Modified Lobene Stain Index (MLSI) using the MacPhearson sites

E.5.1.1

Timepoint(s) of evaluation of this end point

6 weeks

E.5.2

Secondary end point(s)

Modified Lobene Stain Index (MLSI) using the MacPhearson sites

E.5.2.1

Timepoint(s) of evaluation of this end point

3 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

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

The study aims to investigate the control of a labelled, aesthetic, undesirable effect (i.e. tooth staining)

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

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

Aquafresh Fresh & Minty toothpaste (non-sodium bicarbonate toothpaste, reference product, cosmetic)

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:

160

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

160

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 full dental prophylaxis by a dental professional to remove any 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

2013-06-19

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-08-12

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2013-11-20

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