Clinical Trials Register

Summary
EudraCT Number:	2011-002443-10
Sponsor's Protocol Code Number:	2011035
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:	2011-06-14
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

2011-002443-10

A.3

Full title of the trial

A Randomized, Open-Label, Single-Dose, Parallel Group Study to Evaluate the Utility of Magnetic Resonance Imaging (MRI) in Demonstrating the Nasal Decongestant Efficacy of an Active Control (Vicks® Sinex® Micromist®) Relative to a Sham Control at 8 and 12 Hours Post-Dosing

A.3.1

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

Investigation of the ability of MRI to show changes in the nose after treatment of patients with Vicks® Sinex® Micromist®

A.4.1

Sponsor's protocol code number

2011035

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	Procter & Gamble Technical Centres Ltd., UK
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	Proctor & Gamble (Health and Beauty Care) 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	School of Physics and Astronomy
B.5.2	Functional name of contact point	Penny Gowland
B.5.3	Address:
B.5.3.1	Street Address	Sir Peter Mansfield Magnetic Resonance Centre,
B.5.3.2	Town/ city	University Park, Nottingham
B.5.3.3	Post code	NG7 2RD
B.5.3.4	Country	United Kingdom
B.5.4	Telephone number	(+44) (0) 115 95 1475
B.5.6	E-mail	penny.gowland@nottingham.ac.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	Vicks® Sinex Micromist®
D.2.1.1.2	Name of the Marketing Authorisation holder	Procter & Gamble (Health & Beauty Care) 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.3.4	Pharmaceutical form	Nasal spray, solution
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Nasal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	OXYMETAZOLINE HYDROCHLORIDE
D.3.9.1	CAS number	2315-02-8
D.3.9.4	EV Substance Code	SUB03589MIG
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	0.05
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

Nasal Congestion due to the common cold or hay fever

E.1.1.1

Medical condition in easily understood language

stuffy or blocked nose due to the common cold or hay fever

E.1.1.2

Therapeutic area

Diseases [C] - Ear, nose and throat diseases [C09]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	13.1
E.1.2	Level	PT
E.1.2	Classification code	10028735
E.1.2	Term	Nasal congestion
E.1.2	System Organ Class	10038738 - Respiratory, thoracic and mediastinal 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

The primary objective of this method development study is to evaluate the utility of MRI in demonstrating the nasal decongestant efficacy of an active control (Vicks® Sinex® Micromist®) at 8 and 12 hours after dosing relative to a sham control.

E.2.2

Secondary objectives of the trial

None

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Subjects meeting all of the following criteria will be considered for admission to this study:

a) have provided written informed consent;
b) are generally healthy by report and review of medication/medical history;
c) are at least 18 years of age and not older than 65 years of age, inclusive, at screening;
d) report suffering from nasal congestion due to common cold or hay fever;
e) rate the severity of their nasal congestion as either a 2=Moderate (definite awareness of sign/symptom that is bothersome but tolerable) or 3=Severe (sign/symptom that is hard to tolerate) on the Nasal Congestion Severity Scale (Section 3.4.2.1);
f) if female and of child-bearing potential, have practiced abstinence or used an effective form of birth control (e.g., intrauterine device, oral contraceptives, contraceptive implants or injections, diaphragm with spermicide, cervical cap, or consort use of condom) for at least 3 months before being enrolled in the study;
g) have a body mass index (BMI) ≥18.5 but ≤ 32 kg/m2;
h) be willing to refrain from exercise, alcohol, hot spicy food, hot drinks and any medication, homeopathic, home remedy, dietary supplement, herbal remedy, and saline spray listed in the exclusion criteria throughout the study;
i) be willing and able to comply with MRI instructions (Appendix 3);
j) be willing to refrain from smoking, eating and drinking during Visit 1 and starting 1 hour prior to and during Visit 2 (room temperature water will be permitted ad lib while at the site); and,
k) have a peak nasal inspiratory flow of < 105 L/min (Section 3.4.2.2).

E.4

Principal exclusion criteria

Subjects will be excluded from the study if any of the following apply:

a) are female and have a positive urine pregnancy test at screening or report they are pregnant, trying to become pregnant, or lactating;
b) have a body temperature greater than 38.1º Celsius;
c) have blood pressure exceeding either 138mm Hg systolic or 88mm Hg diastolic (an average of three readings after sitting for 5 minutes);
d) have a history of rhinitis medicamentosa or frequent nose bleeds;
e) have a dependence upon nasal, oral, or ocular decongestants, that, in the opinion of the Investigator would interfere with the evaluation of the study, pose a safety risk, or confound the interpretation of the study results;
f) have a clinically significant nasal abnormality (e.g., deviated septum, ulcer, septal perforation, or polyp) discovered during the nasal examination;
g) have a history of cardiovascular disease, thyroid disease, diabetes mellitus, hypertension, prostatic hypertrophy, hepatic or renal disease;
h) have a history of clinically significant pulmonary, autoimmune, psychiatric, metabolic, neurologic, hematologic/oncologic (except for treated basal cell carcinoma with a documented 6-month remission), metabolic, endocrine or gastrointestinal disease;
i) have an acute illness (other than cold and hay fever) during the two weeks preceding the study or have a condition or are taking a medication that the Investigator believes would interfere with the evaluation of the study, pose a safety risk, or confound the interpretation of the study results;
j) have a history of allergy or hypersensitivity or abnormal reaction to Vicks® Sinex® Micromist® or the following ingredients: oxymetazoline hydrochloride, levomenthol, sodium citrate dihydrate, tyloxapol, citric acid anhydrous, chlorhexidine gluconate solution, benzalkonium chloride solution, camphor, disodium edetate dihydrate, eucalyptol, sodium hydroxide and purified water
k) have a history of alcohol or drug abuse within the past 2 years;
l) have used intranasal or systemic corticosteroids or leukotriene antagonists/synthase inhibitors within the past 30 days;
m) have used inhaled, topical, or oral nedocromil or intranasal cromolyn, tricyclic antidepressant medications, or MAO inhibitors within the past 14 days;
n) have used intranasal or systemic decongestants or intranasal or systemic antihistamines within the past 3 days;
o) are taking bromocriptine, antibiotics or antiviral medications;
p) have consumed alcohol, nasal, throat or lung inhalants, or any products (e.g., medications, homeopathics, home remedies, dietary supplements, herbal remedies, saline sprays) for common cold or hay fever within the past 12 hours;
q) have exercised within the past 6 hours;
r) are currently enrolled in another clinical trial, or have received any other investigational drug within the past 3 months;
s) do not meet all the criteria in the MR Safety Screening Questionnaire (Appendix 2)
t) are unable to follow MRI instructions (Appendix 3);
u) have demonstrated an unwillingness to comply with protocol requirements (e.g., uncooperative attitude, inability to return for all scans, history of medical non-compliance) and/or poor likelihood of completing the study.

E.5 End points

E.5.1

Primary end point(s)

As Above

E.5.1.1

Timepoint(s) of evaluation of this end point

8hr, 12hr

E.5.2

Secondary end point(s)

none

E.5.2.1

Timepoint(s) of evaluation of this end point

n/a

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

Yes

E.6.13.1

Other scope of the trial description

efficacy in reduction of nasal airway resistance (NAR) out to 12 hours

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

Yes

E.8.1.3

Single blind

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

Sham treatment with empty Vicks® Sinex® Micromist® bottle

E.8.2.4

Number of treatment arms in the trial

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.8.5.1

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

END OF VISIT PROCEDURES
Subjects will be compensated for their participation in the study and discharged from the study centre.

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)

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

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

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.4.2

For a multinational trial

F.4.2.2

In the whole clinical trial

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)

Not Applicable

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

2011-06-23

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-06-23

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2012-03-21

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