Safety and Efficacy of Sublingual Immunotherapy (SLIT) Tablets in Grass Pollen Rhinoconjunctivitis

This study has been completed.

Sponsor:

Information provided by:

Stallergenes

ClinicalTrials.gov Identifier:

NCT00367640

First received: August 22, 2006

Last updated: October 8, 2009

Last verified: October 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

August 22, 2006

Last Updated Date

October 8, 2009

Start Date ^ICMJE

November 2004

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

• To assess the efficacy of SLIT on the Rhinoconjunctivitis Total Symptom Score (RTSS)

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00367640 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Rescue medication usage.
6individual symptom scores of the Rhinoconjunctivitis Symptom Score (RSS).
Overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score.
Global evaluation by the patient.
To document the safety of the treatment

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Safety and Efficacy of Sublingual Immunotherapy (SLIT) Tablets in Grass Pollen Rhinoconjunctivitis

Official Title ^ICMJE

Randomised,Double-blind,Placebo-controlled,Multinational,Multi-centre,Phase IIb/III Study of the Efficacy and Safety of Three Doses of Sublingual Immunotherapy (SLIT) Administered as Tablets Once Daily to Patients Suffering From Grass Pollen Rhinoconjunctivitis

Brief Summary

To evaluate the safety and efficacy of SLIT compared with placebo for reduction of symptoms and rescue medication usage

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2
Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Allergy

Intervention ^ICMJE

Biological: Sublingual immunotherapy tablets - grass pollen

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

600

Completion Date

August 2005

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Written consent
Grass-pollen related allergic rhinoconjunctivitis for at least the last 2 pollen seasons.
Sensitised to grass pollen (positive SPT and RAST level of at least class 2).
Total symptom score of the RRTSS during the previous pollen season greater than or equal to 12.
Safety laboratory resuts within the references ranges

Gender

Both

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Not Provided

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00367640

Other Study ID Numbers ^ICMJE

VO34.04

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Stallergenes

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Alain DIDIER, Professor

Hôpital Rangueil-Larrey, Toulouse, France

Information Provided By

Stallergenes

Verification Date

October 2009

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

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