Efficacy and Safety of Lectranal® in Treatment of Seasonal Allergic Rhinitis Symptoms - Tabular View

Tracking Information

First Received Date ^ICMJE

April 13, 2007

Last Updated Date

December 28, 2007

Start Date ^ICMJE

April 2007

Primary Completion Date

October 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

changes in SARS (seasonal allergic rhinitis symptoms) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
changes in Mini RQLQ (mini rhinoconjunctivitis quality of life questionnaire) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
changes in specific IgE [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
changes in specific IgG [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

changes in SARS (seasonal allergic rhinitis symptoms) at 6 weeks
changes in Mini RQLQ (mini rhinoconjunctivitis quality of life questionnaire)at 6 weeks
changes in specific IgE at 6 weeks
changes in specific IgG at 6 weeks

Change History

Complete list of historical versions of study NCT00460538 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Prick test change [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
change in eosinophilia in nasal secretion [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Prick test change in 6 weeks
change in eosinophilia in nasal secretion at 6 weeks

Descriptive Information

Brief Title ^ICMJE

Efficacy and Safety of Lectranal® in Treatment of Seasonal Allergic Rhinitis Symptoms

Official Title ^ICMJE

Efficacy and Safety of Lectranal® in Treatment of Seasonal Allergic Rhinitis Symptoms

Brief Summary

The purpose of the study is to determine weather Lectranal is effective in treatment of seasonal allergic rhinitis symptoms.

Detailed Description

Patients allergic to the specific pollen are divided into two groups randomly. One group is being administered Lectranal and the other group is being administered placebo during the period of 6 weeks in season of the pollen. Methods used for evaluation are: SARS questionnaire(seasonal allergic rhinitis symptoms), Mini RQLQ (mini rhinoconjunctivitis quality of life questionnaire) skin Prick test, specific IgE and IgG, eosinophilia in nasal secretion. Methods used for follow up safety include side effects report, physical examination and vital signs.

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Seasonal Allergic Rhinitis

Intervention ^ICMJE

Dietary Supplement: Lectranal
Dietary Supplement: placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

November 2007

Primary Completion Date

October 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

history of seasonal allergic rhinitis symptoms to pollen
positive skin prick test to pollen
negative history of seasonal allergic asthma
male or female older than 18
female participants must use appropriate contraception
able to comply to study procedures

Exclusion Criteria:

pregnancy
alcohol or drug abuse
subject receiving antihistamines , immunotherapy or on hyposensibilisation

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Croatia

Administrative Information

NCT ID ^ICMJE

NCT00460538

Responsible Party

Neven Tudoric MD PhD, Dubrava University Hospital, Zagreb, Croatia

Study ID Numbers ^ICMJE

MIL-002

Study Sponsor ^ICMJE

Milsing d.o.o.

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Neven Tudoric, MD PhD

Dubrava University Hospital

Information Provided By

Milsing d.o.o.

Verification Date

December 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP