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Clinical Trials/EUCTR2006-005461-19-CZ
EUCTR2006-005461-19-CZActive, not recruitingPhase 1

A Randomized, Double Blind, Placebo Controlled Multicenter Study to Assess the Tolerability and Safety of ANTIRIN® nasal spray and drops in two Age Groups of Children with Acute Rhinitis

Zentiva a.s.0 sites240 target enrollmentStarted: October 13, 2006Last updated:
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Conditions

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Enrollment
240
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •To participate in this trial, patients will have to meet all of the following criteria:
  • •established diagnosis of acute rhinitis. All following criteria must be met:
  • •othe occurrence of two nasal symptoms at least: congestion, rhinorrhea, mucosa burning or itching, sneezing
  • •oduration of nasal symptoms = 30 days
  • •no topical decongestives during last 7 days
  • •patients between 2 – 7 years, both genders ……Group I
  • •patients between 8 – 18 years, both genders ……Group II
  • •written informed consent obtained of patient s guardian and patient (if possible)
  • •good collaboration with parents
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) no
  • •F.1.2.1 Number of subjects for this age range
  • •F.1.3 Elderly (>=65 years) no
  • •F.1.3.1 Number of subjects for this age range

Exclusion Criteria

  • •Patients meeting any of the following criteria will be excluded from participation in this study:
  • •Rhinitis which originated before more than 30 days
  • •Rhinitis medicamentosa
  • •Rhinitis sicca
  • •Otitis media
  • •patients with unstable bronchial asthma
  • •patients with unstable endocrine disease
  • •patients with the history of narrow angle glaucoma
  • •patients with history of hypersensitivity to the study drug or its excipients
  • •patients taking the following drugs:
  • •othe need of administration of local (nasal) corticosteroid drugs
  • •ouse of any other nasal decongestant drugs orally or locally ( e.g. intransally) within 7 days prior inclusion
  • •oSystemic corticosteroids: changes in dose within 7 days prior inclusion
  • •oAntihistamin drugs: changes in dose within 7 days prior inclusion
  • •oantihypertensive drugs that may influence nasal congestion within 7 days prior inclusion ( beta blockers, ACE inhibitors, alpha adrenergic antagonists i.e. prazosin)
  • •oMAO inhibitors and other drugs with hypertensive potential within 14 days prior inclusion.
  • •patients with the history of nasal polyps
  • •patients with major nasal septum deviation
  • •any other disease or condition which may interfere with study assessments as judged by the investigator
  • •patients taking part in any other clinical trial or having participated in a clinical trial within the previous 3 months
  • •clinically significant renal/hepatic impairment or serious heartdisease and uncontrolled hypertension
  • •patients with pheochromocytoma
  • •patients presenting any malignant disease
  • •patients likely not to comply with the study procedures or with difficulties to understand the study procedures as judged by the investigator

Investigators

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A Randomized, Double Blind, Placebo... | Clinical Trial