Clinical Trials Register

Summary
EudraCT Number:	2021-002058-96
Sponsor's Protocol Code Number:	SAN-0657
National Competent Authority:	Poland - Office for Medicinal Products
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2021-09-22
Trial 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

Poland - Office for Medicinal Products

A.2

EudraCT number

2021-002058-96

A.3

Full title of the trial

Efficacy and safety of the combination of acetylcysteine, paracetamol and phenylephrine for the treatment of common cold: a prospective, randomized, double-blind, controlled trial

A.3.1

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

Efficacy and safety of the combination of acetylcysteine, paracetamol and phenylephrine for the treatment of common cold

A.3.2

Name or abbreviated title of the trial where available

non available

A.4.1

Sponsor's protocol code number

SAN-0657

A.5.4

Other Identifiers

Name:

CRO code number

Number:

CLK20001

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	Lek Pharmaceuticals d.d.
B.1.3.4	Country	Slovenia
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	Lek Pharmaceuticals d.d.
B.4.2	Country	Slovenia
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Lek Pharmaceuticals d.d.
B.5.2	Functional name of contact point	Group Head Clinical Development
B.5.3	Address:
B.5.3.1	Street Address	Verovškova ulica 57
B.5.3.2	Town/ city	Ljubljana
B.5.3.3	Post code	1526
B.5.3.4	Country	Slovenia
B.5.4	Telephone number	+38615802800
B.5.5	Fax number	+38615683517
B.5.6	E-mail	aleksander.bajc@sandoz.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	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	Acetylcysteine/Paracetamol/Phenylephrine granules for oral solution (200 mg/500 mg/10 mg)
D.3.2	Product code	Test
D.3.4	Pharmaceutical form	Granules for oral solution in sachet
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	ACETYLCYSTEINE
D.3.9.1	CAS number	616-91-1
D.3.9.2	Current sponsor code	acetylcysteine
D.3.9.3	Other descriptive name	N-acetylcysteine
D.3.9.4	EV Substance Code	SUB05229MIG
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	200
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.3.9.2	Current sponsor code	Paracetamol
D.3.9.3	Other descriptive name	Acetaminophen
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.3.8	INN - Proposed INN	PHENYLEPHRINE
D.3.9.1	CAS number	59-42-7
D.3.9.2	Current sponsor code	Phenylephrine
D.3.9.3	Other descriptive name	Phenylephrine
D.3.9.4	EV Substance Code	SUB09788MIG
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	10
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	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	Paracetamol/Phenylephrine (500 mg/10 mg) granules for oral solution
D.3.2	Product code	Comparator
D.3.4	Pharmaceutical form	Granules for oral solution in sachet
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.3.9.2	Current sponsor code	Paracetamol
D.3.9.3	Other descriptive name	Acetaminophen
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.3.8	INN - Proposed INN	PHENYLEPHRINE
D.3.9.1	CAS number	59-42-7
D.3.9.2	Current sponsor code	Phenylephrine
D.3.9.3	Other descriptive name	Phenylephrine
D.3.9.4	EV Substance Code	SUB09788MIG
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	10
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 and flu-like infections

E.1.1.1

Medical condition in easily understood language

common cold, flu

E.1.1.2

Therapeutic area

Diseases [C] - Virus Diseases [C02]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	22.1
E.1.2	Level	LLT
E.1.2	Classification code	10010106
E.1.2	Term	Common cold
E.1.2	System Organ Class	100000004862

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.1
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	100000004862

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 the present trial is the assessment the efficacy of an investigational fixed combination medicinal product containing Acetylcysteine/Paracetamol/Phenylephrine (200 mg/500 mg/10 mg) per sachet with granules for oral solution compared to a combination medicinal product containing Paracetamol/Phenylephrine (500 mg/10 mg) per sachet with granules for oral solution for the treatment of common cold.

E.2.2

Secondary objectives of the trial

To assess the safety and tolerability of the investigational medicinal product against the comparator product for the treatment of common cold.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

[1] Male or female subjects aged between 18 and 75 years inclusive on the date of consent
[2] No fever or (mild) fever below 38.5° C
[3] Total score (sum of all ratings) of 2 or higher based on the rating of the following symptoms of common cold (Jackson scale):
a. Sneezing
b. Nasal discharge
c. Nasal obstruction
d. Sore throat
e. Cough
f. Headache
g. Malaise
h. Chilliness
according to the following rating scale: 0 = absent, 1 = mild, 2 = moderate, or 3 = severe
[4] Presence of cough with thick mucus production
[5] Informed consent to participate in the trial provided in written form.

E.4

Principal exclusion criteria

[1] Duration of any of the symptoms of common cold of more than 72 hours at the time of screening
[2] History of hypersensitivity or intolerance to the active substances or any of the excipients of the trial medication
[3] Known bronchial asthma or chronic obstructive pulmonary disease
[4] Known duodenal or gastric ulcer
[5] Known hyperthyroidism
[6] Known narrow angle glaucoma
[7] Known pheochromocytoma
[8] Known prostate adenoma with urine retention
[9] Known severe liver failure (Child-Pugh > 9)
[10] Known severe cardio-vascular diseases
[11] Known porphyria
[12] Known glucose-6-phosphate dehydrogenase deficiency
[13] High fever (body temperature above 38.5°C)
[14] Intake of antibiotics, immunosuppressing, immuno-stimulating or immuno-modulating medication, within 30 days prior to screening visit
[15] Intranasal or systemic use of corticosteroids within 30 days prior to screening visit
[16] Intake of antihistamines or nasal decongestants within 48 hours prior to screening visit
[17] Vaccination within 14 days prior to screening visit
[18] Immunocompromised state
[19] Suspicion for acute bacterial infection
[20] Pregnant or breast-feeding female patient
[21] Female patient of childbearing potential (not surgically sterilized/ hysterectomized or postmenopausal for at least 1 year) who is not currently using (documented at screening visit) and not willing to use medically reliable methods of contraception for the entire trial duration such as barrier method, oral, injectable or implantable contraceptives, intrauterine contraceptive devices (IUD), sexual abstinence or vasectomized partner
[22] Any other condition of the patient (e.g. serious or unstable medical or psychological condition, acute psychosis) that in the opinion of the investigator may compromise evaluation of the trial treatment or may jeopardize patient’s safety, compliance or adherence to protocol requirements
[23] Participation in ANY research study involving another investigational medicinal product (IMP) within 30 days prior to screening visit, or simultaneous participation in another clinical study or previous participation in present study
[24] Suspected alcohol/ drug dependence or abuse (including heavy smoking: ≥ 20 cigarettes daily)
[25] Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequences of the trial
[26] Subjects who are known or suspected:
- not to comply with the trial directives
- not to be reliable or trustworthy
- to be a dependent person, e.g. a relative, family member, or member/ employee of the investigator’s or sponsor’s staff
- subject is in custody or submitted to an institution due to a judicial order.

E.5 End points

E.5.1

Primary end point(s)

Sum of changes from baseline in the daily SUM8 over the entire treatment period

E.5.1.1

Timepoint(s) of evaluation of this end point

After closing the database and unbliniding the trial

E.5.2

Secondary end point(s)

• Time to onset of action defined as first day of treatment with investigational product on which SUM8 shows statistically significant difference from the comparator product
• SUM8 development over the course of the study
• Assessment of separate items of SUM8
• Sum of changes from baseline in the daily WURSS-21 over the entire treatment period
• Assessment of separate items of WURSS-21
• Percentage of responders and non-responders to treatment based on the assessment of overall response to treatment by the investigator.

E.5.2.1

Timepoint(s) of evaluation of this end point

After closing the database and unbliniding the trial

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

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.8.2.4

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

Yes

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

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Russian Federation

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 is Visit 3 on Day 6 (+2)

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:

200

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

250

F.4.2

For a multinational trial

F.4.2.1

In the EEA

750

F.4.2.2

In the whole clinical trial

1002

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)

None

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

2021-10-24

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-09-07

P. End of Trial
P.	End of Trial Status	Ongoing

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