Flag of the European Union		EU Clinical Trials Register	Help
Home & Search Joining a trial Contacts About About the EU clinical trials registerWhat's newData qualityClinical trial sponsorsNational medicine regulatory authoritiesLinks
Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on: 
interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis. 

The EU Clinical Trials Register currently displays   26338   clinical trials with a EudraCT protocol, of which   3859   are clinical trials conducted with subjects less than 18 years old. 
The register also displays information on   18612   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
 
 
Examples: Cancer AND drug name. Pneumonia AND sponsor name. 
How to search [pdf]
Advanced Search:	Search tools
 
< Back to search results

  Print Download

Summary
EudraCT Number:	2004-002276-42
Sponsor's Protocol Code Number:	61/O4/OX/Rh
National Competent Authority:	Czech Republic - SUKL
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2004-11-10
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
Expand All   Collapse All
A. Protocol Information 
A.1	Member State Concerned	Czech Republic - SUKL
A.2	EudraCT number	2004-002276-42
A.3	Full title of the trial	
Tolerability and safety of Oxamet® in patients with acute rhinitis
A.4.1	Sponsor's protocol code number	61/O4/OX/Rh
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	IVAX Pharmaceuticals s.r.o.
B.1.3.4	Country	Czech Republic
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	Information not present in EudraCT
D.2.1.1.1	Trade name	Oxamet® 0.5‰
D.2.1.1.2	Name of the Marketing Authorisation holder	IVAX Pharmaceuticals s.r.o.
D.2.1.2	Country which granted the Marketing Authorisation	Czech Republic
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	Oxamet® 0.5‰
D.3.4	Pharmaceutical form	Nasal spray, solution
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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	oxymetazolini hydrochloridum
D.3.9.1	CAS number	2315-02-8
D.3.9.3	Other descriptive name	oxymetazoline hydrochloride; oxymetazolinhydrochlorid
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)	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	Information not present in EudraCT
D.3.11.8	Extractive medicinal product	Information not present in EudraCT
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	
Acute rhinitis.
MedDRA Classification
E.1.3	Condition being studied is a rare disease	No
E.2 Objective of the trial
E.2.1	Main objective of the trial	
To evaluate the safety and tolerability of Oxamet® in patients with acute rhinitis.
E.2.2	Secondary objectives of the trial	
To demonstrate the efficacy of Oxamet® in patients with acute rhinitis.
E.2.3	Trial contains a sub-study	Information not present in EudraCT
E.3	Principal inclusion criteria	
1.Male or female at the age of 18-65 years 
2.Diagnosis of acute rhinitis 
3.Patient assessment of obstruction - level 2 or more
E.4	Principal exclusion criteria	
1.Nasal abnormalities causing obstruction
2.Significant history of hypersensitivity to oxymetazoline or other components of the tested product 
3.Pregnant or lactating females, or likelihood pregnancy
4.Severe cardiovascular disease: hypertension, ischemic heart disease
5.Pacemark-dependent cardiac rhythm
6.Rhinitis sicca
7.Metabolic disorders: diabetes mellitus, hyperthyroidism
8.Pheochromocytoma
9.Men with hyperplasia of prostate
10.No history or evidence of malignancy of nose or paranasal sinuses
11.Concomitant therapy with MAO inhibitors or tricyclic antidepressives
12.Severe respiratory disease
E.5 End points
E.5.1	Primary end point(s)	
Assessment of symptoms:
- burning
- sneezing
- itching 
- dryness of nassal mucosa
- stinging
Adverse events-character, frequency, severity, causality and intensity level.
Vital signs.
E.6 and E.7 Scope of the trial
E.6	Scope of the trial
E.6.1	Diagnosis	No
E.6.2	Prophylaxis	No
E.6.3	Therapy	No
E.6.4	Safety	Yes
E.6.5	Efficacy	Yes
E.6.6	Pharmacokinetic	No
E.6.7	Pharmacodynamic	No
E.6.8	Bioequivalence	No
E.6.9	Dose response	No
E.6.10	Pharmacogenetic	Information not present in EudraCT
E.6.11	Pharmacogenomic	No
E.6.12	Pharmacoeconomic	No
E.6.13	Others	No
E.7	Trial type and phase
E.7.1	Human pharmacology (Phase I)	No
E.7.1.1	First administration to humans	No
E.7.1.2	Bioequivalence study	No
E.7.1.3	Other	No
E.7.1.3.1	Other trial type description	
E.7.2	Therapeutic exploratory (Phase II)	No
E.7.3	Therapeutic confirmatory (Phase III)	No
E.7.4	Therapeutic use (Phase IV)	Yes
E.8 Design of the trial
E.8.1	Controlled	No
E.8.1.1	Randomised	No
E.8.1.2	Open	No
E.8.1.3	Single blind	No
E.8.1.4	Double blind	No
E.8.1.5	Parallel group	No
E.8.1.6	Cross over	No
E.8.1.7	Other	No
E.8.2	Comparator of controlled trial
E.8.2.1	Other medicinal product(s)	No
E.8.2.2	Placebo	No
E.8.2.3	Other	No
E.8.3	The trial involves single site in the Member State concerned	No
E.8.4	The trial involves multiple sites in the Member State concerned	Yes
E.8.5	The trial involves multiple Member States	No
E.8.6 Trial involving sites outside the EEA
E.8.6.1	Trial being conducted both within and outside the EEA	No
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	Information not present in EudraCT
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	
E.8.9 Initial estimate of the duration of the trial
E.8.9.1	In the Member State concerned years	0
E.8.9.1	In the Member State concerned months	12
E.8.9.1	In the Member State concerned days	
E.8.9.2	In all countries concerned by the trial years	0
E.8.9.2	In all countries concerned by the trial months	0
F. Population of Trial Subjects 
F.1 Age Range
F.1.1	Trial has subjects under 18	No
F.1.1.1	In Utero	Information not present in EudraCT
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	Information not present in EudraCT
F.1.1.3	Newborns (0-27 days)	Information not present in EudraCT
F.1.1.4	Infants and toddlers (28 days-23 months)	Information not present in EudraCT
F.1.1.5	Children (2-11years)	Information not present in EudraCT
F.1.1.6	Adolescents (12-17 years)	Information not present in EudraCT
F.1.2	Adults (18-64 years)	Yes
F.1.3	Elderly (>=65 years)	No
F.2 Gender
F.2.1	Female	Yes
F.2.2	Male	Yes
F.3 Group of trial subjects
F.3.1	Healthy volunteers	No
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	Information not present in EudraCT
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 2004-11-10.	Yes
F.3.3.2	Women of child-bearing potential using contraception	Information not present in EudraCT
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	1540
G. Investigator Networks to be involved in the Trial 
N. Review by the Competent Authority or Ethics Committee in the country concerned 
N.	Competent Authority Decision	Authorised
N.	Date of Competent Authority Decision	2004-11-19
N.	Ethics Committee Opinion of the trial application	Favourable
N.	Ethics Committee Opinion: Reason(s) for unfavourable opinion	
N.	Date of Ethics Committee Opinion	2004-12-13
P. End of Trial 
P.	End of Trial Status	Ongoing
EU Clinical Trials Register Service Desk: euctr@ema.europa.eu 
European Medicines Agency © 1995-2015 | 30 Churchill Place, Canary Wharf, London E14 5EU Legal notice
EMAHMA
 davido.extraxim@gmail.com