Clinical Trials Register

Summary
EudraCT Number:	2010-021653-39
Sponsor's Protocol Code Number:	075-A-301
National Competent Authority:	Germany - BfArM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2010-09-10
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

Germany - BfArM

A.2

EudraCT number

2010-021653-39

A.3

Full title of the trial

A randomized, double-blind, parallel group, single-dose study of the efficacy of lidocaine 8 mg + cetylpyridinium chloride (CPC) 2 mg fixed combination lozenges on sore throat pain intensity compared to Mebucaine CL lozenges (containing lidocaine 1 mg and CPC 2 mg) in subjects with sore throat due to upper respiratory tract infection

A.4.1

Sponsor's protocol code number

075-A-301

A.7

Trial is part of a Paediatric Investigation Plan

Information not present in EudraCT

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Novartis Consumer Health S.A.
B.1.3.4	Country	Switzerland
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
B.4.2	Country
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	No
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	Lidocaine 8 mg + CPC 2 mg fixed combination lozenge
D.3.2	Product code	[CPC 2mg, Lidocaine 8mg] Lozenge
D.3.4	Pharmaceutical form	Lozenge
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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	73-78-9
D.3.9.3	Other descriptive name	LIDOCAINE HYDROCHLORIDE
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	8
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	CETYLPYRIDINIUM CHLORIDE
D.3.9.1	CAS number	123035
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	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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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	Comparator
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	Mebucaine Mint szopogató tabletta
D.2.1.1.2	Name of the Marketing Authorisation holder	Novartis Hungaria Kft. (Consumer Health részlege)
D.2.1.2	Country which granted the Marketing Authorisation	Hungary
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	Mebucaine CL lozenges
D.3.4	Pharmaceutical form	Lozenge
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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	73-78-9
D.3.9.3	Other descriptive name	LIDOCAINE HYDROCHLORIDE
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	1
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	CETYLPYRIDINIUM CHLORIDE
D.3.9.1	CAS number	123035
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	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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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

Sore throat due to upper respiratory tract infection

(Planned indication for approval:
Local antiseptic and analgesic treatment of sore throat and minor infections of the mouth.
Relief of pain as well as irritation associated with these conditions in adults and adolescents aged 12 years and above.)

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	12.1
E.1.2	Level	LLT
E.1.2	Classification code	10041367
E.1.2	Term	Sore throat

E.1.2 Medical condition or disease under investigation

E.1.2	Version	12.1
E.1.2	Level	LLT
E.1.2	Classification code	10068319
E.1.2	Term	Oropharyngeal pain

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 main purpose of this trial is to compare the efficacy and safety of a single dose of a lidocaine 8 mg + 2 mg cetylpyridinium (CPC) lozenge with a single dose of a Mebucaine CL lozenge (containing 1 mg lidocaine and 2 mg CPC) in the treatment of sore throat due to upper respiratory tract infection.

Efficacy will be demonstrated as superiority vs. Mebucaine CL on the primary efficacy outcome, which is the change from baseline to 2 hours post-dose for sore throat pain intensity. Safety will be evaluated by looking at nature and incidence of adverse events.

Primary objective:
- To compare the efficacy of a new fixed dose combination lozenge (8 mg Lidocaine + 2 mg CPC) with that of a marketed Mebucaine CL lozenge (1 mg Lidocaine + 2 mg CPC) on sore throat pain intensity in subjects with upper respiratory tract infection.

The primary endpoint based on the sore throat pain intensity scale will be the change from baseline pain intensity at 2 hours post-dose.

E.2.2

Secondary objectives of the trial

Secondary objective:
- To determine and compare the onset and duration of analgesia achieved with each treatment
- To determine and compare the effect on swallowing difficulties of each treatment
- To determine and compare the global assessment of study medication
- To evaluate the antimicrobial effect, versus baseline, of each treatment
- To evaluate safety of both treatments by looking at nature and incidence of adverse events

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Subjects eligible for inclusion in this study must fulfill all of the following criteria. Criteria 1-5 must be met at screening; criterion 5 must also be met immediately prior to dosing.
1. Given written informed consent before any assessment is performed.
2. Male or female aged 18 years or over.
3. A primary diagnosis of sore throat, of onset ≤ 48 hours prior to screening, and ≤ 56 hours prior to dosing, due to URTI
4. A Tonsillopharyngitis Assessment (TPA) score ≥ 5 on the expanded TPA scale (Schachtel et al, 2002; Schachtel 1984c, Eccles et al 2003)
5. A Sore Throat Pain Intensity score of at least 60 mm on the Sore Throat Pain Intensity Scale (a Visual Analogue Scale of 100 mm ranging from no pain at the left and to worst possible pain at the right) both at screening and immediately before dosing. Subjects should be asked to swallow before Sore Throat Pain intensity is recorded.

E.4

Principal exclusion criteria

Subjects must be excluded from this study if they fit any of the following criteria listed below at screening or at the beginning of the study. Criterion 22 must be regularly verified, from the clinical point of view, during the course of the study.
1. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer
2. Women of child-bearing potential (defined as all women physiologically capable of becoming pregnant) who are not using an acceptable method of contraception defined as:
- Surgical sterilization
- Hormonal contraception
- IUD
- Double barrier method
- Total abstinence throughout the study at the discretion of the Investigator.
Periodic abstinence is NOT acceptable. An acceptable method of contraception must be maintained throughout the study.
A woman who is postmenopausal must have a negative urine pregnancy test at screening but will not need to comply with an acceptable method of contraception.
3. History of hypersensitivity to any of the study drugs and the listed excipients or to drugs of similar chemical classes
4. Evidence of mouth breathing such as significant nasal congestion in both nostrils (Schachtel et al. 1984b)
5. Evidence of severe coughing
6. Pregnant or nursing (lactating women); positive pregnancy test at screening.
7. Any disease that could compromise breathing e.g. bronchopneumonia
8. Use of any analgesic or NSAID within 5 half-lives prior to dosing
9. Use of any antipyretic, antitussive or decongestant medications within 8 hours prior to dosing.
10. Use of any medicated confectionary, throat lozenges, throat pastilles, sprays, any products with demulcent properties such as boiled sweets or mints, in the 2 hours prior to dosing.
11. Use of any medication for sore throat containing a local anaesthetic within the 4 hours prior to dosing.
12. Use of antibiotics within the previous 14 days.
13. Any painful condition with an intensity that it may distract attention from sore throat pain at the discretion of the investigator, including but not limited to mouth ulcers, joint pain, back pain, sinusitis.
14. Evidence of overt oropharyngeal bacterial or fungal infection (e.g. purulent exudate, oral candidiasis) or evidence of lower respiratory tract infection.
15. Severe renal, liver or cardiac impairment. Severe lung disease.
16. A history of alcohol abuse or an admission by the subject that they regularly consume alcoholic food or beverages of ≥ 40 g pure ethanol for male or ≥ 20 g for female per day .
17. Heavy smokers (use of 20 or more cigarettes per day)
18. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
19. Those previously randomized into the study.
20. Those unable, in the opinion of the Investigator, to comply with the study requirements. e.g. those who cannot comprehend or correctly use the scales.
21. Employees or relatives of employees of the investigational site
22. Fever that, in the opinion of the investigator, may interfere with the ability of the subject to participate in the study

E.5 End points

E.5.1

Primary end point(s)

The primary endpoint is change from baseline pain intensity at 2 hours post-dose.

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

Yes

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)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

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

Information not present in EudraCT

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

last visit of the last subject

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.1.3

Elderly (>=65 years)

Yes

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 2010-09-10.

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

250

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 with clinical signs and symptoms of streptococcal sore throat or with significant sore throat pain following discharge from the unit (4 h p.a.), will be advised to see their own doctor. For details see study protocol, chapter 1 as well as Annex 8 of Modul 1.

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

2010-11-23

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2010-12-08

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2011-06-30

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