Clinical Trials Register

Summary
EudraCT Number:	2011-004466-14
Sponsor's Protocol Code Number:	RH01361
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:	2011-09-21
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

2011-004466-14

A.3

Full title of the trial

Effects of two doses of a common cold treatment on cognitive function

A.3.1

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

Effects of two doses of a common cold treatment on cognitive function

A.4.1

Sponsor's protocol code number

RH01361

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	Senior Regulatory Affairs Manager
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	441932822291
B.5.5	Fax number	441932822423
B.5.6	E-mail	trevor.j.gilbey@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	Beechams Active Cold Relief Effervescent Tablets
D.2.1.1.2	Name of the Marketing Authorisation holder	SmithKline Beecham (SWG) Limited
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	Paracetamol/Caffeine Effervescent Tablets
D.3.4	Pharmaceutical form	Effervescent tablet
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.3.8	INN - Proposed INN	PARACETAMOL
D.3.9.1	CAS number	103-90-2
D.3.9.4	EV Substance Code	SUB09611MIG
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	500
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	58-08-2
D.3.9.3	Other descriptive name	CAFFEINE
D.3.9.4	EV Substance Code	SUB13146MIG
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	65
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	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	Alvedon 500 mg effervescent tablets
D.2.1.1.2	Name of the Marketing Authorisation holder	GlaxoSmithKline Consumer Healthcare AB
D.2.1.2	Country which granted the Marketing Authorisation	Sweden
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	Alvedon 500 mg effervescent tablets
D.3.4	Pharmaceutical form	Effervescent tablet
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.3.8	INN - Proposed INN	PARACETAMOL
D.3.9.1	CAS number	103-90-2
D.3.9.4	EV Substance Code	SUB09611MIG
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	500
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

Common cold

E.1.1.1

Medical condition in easily understood language

Common cold

E.1.1.2

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.0
E.1.2	Level	LLT
E.1.2	Classification code	10000938
E.1.2	Term	Acute nasopharyngitis (common cold)
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 assess the change in alertness level in people suffering from the common cold, 60 minutes following paracetamol 1000 milligram (mg) and caffeine 130 mg compared to paracetamol 1000 mg. This will be assessed using the number of accurate responses to the Rapid Visual Information Processing (RVIP).

To assess the change in alertness level in people suffering from the common cold, 60 minutes following paracetamol 500 mg and caffeine 65 mg compared to paracetamol 500 mg. This will be assessed using the number of accurate responses to the RVIP.

E.2.2

Secondary objectives of the trial

To assess the change in alertness level 120 minutes following paracetamol/caffeine 1000 mg/ 130 mg and 500 mg/65 mg compared to paracetamol 1000 mg and 500 mg respectively. This will be assessed using the number of accurate responses
to the RVIP and the mean time of accurate responses on the
RVIP task at the 60- minute and 120- minute time points.

To assess the change in alertness level following a dose of paracetamol/caffeine 1000 mg/130 mg and 500 mg/65 mg compared to paracetamol 1000 mg and 500 mg respectively, using a sustained and divided attention task. This will be assessed using the number of accurate responses to the task, and the mean time of accurate response at the 60- minute and 120- minute time points.

Other secondary endpoints are detailed in the protocol.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Diagnosis
a) Present with symptoms of common cold of no more than 96 hours duration prior to the screening visit.
b) On the cold symptoms evaluation have a self-rating of at least “2” for malaise at Visit 1
c) On the cold symptoms evaluation have at least 4 other symptoms
associated with the common cold prior to the treatment visit

E.4

Principal exclusion criteria

Disease
a) Have a history of perennial allergic rhinitis or other chronic respiratory disease that (in the opinion of the investigator) is clinically significant
b) Have a history of psychiatric illness that may affect assessment of
mood
c) Have a hearing deficit that will prevent them from hearing an auditory signal (hearing aids may be worn).

Medications
a) Have used any medication to treat this cold (antibiotics in the last 7 days, antihistamine in the last 72 hours, analgesics or antipyretics in the last 24 hours, decongestant in the last 12 hours, antitussive, medicated lozenge or throat spray in the last 8 hours) at Visit 1.
b) Have taken any menthol containing product in the last 2 hours at Visit 1.
c) Have consumed caffeine (e.g. in tea, coffee, cola or chocolate) in the last 12 hours at Visit 1.
d) Have used any prescription psychoactive medication (such as, but not limited to, anti-depressants, anxiolytics and anti-psychotics) within 14 days of the screening visit.

Allergy/Intolerance
Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.

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

Breast-feeding
Women who are breast–feeding.

E.5 End points

E.5.1

Primary end point(s)

The change from baseline in the number of accurate responses (from the RVIP) at 60 minutes will be compared between treatments.

Paracetamol 1000 mg and caffeine 130 mg vs. paracetamol 1000 mg.
Paracetamol 500 mg and caffeine 65 mg vs. paracetamol 500 mg.

E.5.1.1

Timepoint(s) of evaluation of this end point

The primary timepoint is at 60 minutes post-dosing.

E.5.2

Secondary end point(s)

The comparison of 1000 mg paracetamol + 130 mg caffeine vs. 500 mg paracetamol + 65 mg caffeine is a secondary objective and will only be performed if each of the 2-tablet and 1-tablet active doses has demonstrated superiority against their corresponding control groups.

From the RVIP,

 The number of accurate responses at 120 minutes.
 The mean time of accurate responses in milliseconds.
 The number of inaccurate responses.
 The number of missed responses.

From the sustained and divided attention,

this test consists of two tasks: Sustained auditory attention task and the divided attention task. For each task, the following endpoints will be analysed:
 The number of accurate responses.
 The mean time of accurate responses in milliseconds.
 The number of inaccurate responses.
 The number of missed responses.

Assessment of mood from the Mood, Alertness and Physical Sensations Scales (MAPSS)

E.5.2.1

Timepoint(s) of evaluation of this end point

60 and 120 minutes.

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

Yes

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

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.8.2.4

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.8.4.1

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

Last subject, last visit.

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.1.2.1

Number of subjects for this age range:

220

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

240

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

2011-10-27

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-10-25

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2012-10-31

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