Safety and Tolerability Study of Ragweed SLIT Tablets | NCT01224834

Studies
Safety and Tolerability Study of Ragweed SLIT Tablets

NCT01224834

Sponsor

Stallergenes Greer

Status

Completed

Last Update Posted

Nov 8, 2010Estimated

Enrollment

60Actual

Phase

Phase 1

Conditions

Rhinitis, Allergic, Seasonal
Ragweed Pollen Allergy

Interventions

Sublingual tablet of ragweed pollen allergen extract

Countries

Hungary

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Apr 2009Actual

Completion Date

Oct 2009Actual

First Submitted Date

Oct 13, 2010

First Submission Date that Met QC Criteria

Oct 19, 2010

First Posted Date

Oct 20, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 5, 2010

Last Update Posted Date

Nov 8, 2010Estimated

Name	Class
Quintiles, Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine the safety and tolerability of several doses of ragweed pollen allergen extract administered as sublingual tablets in subjects with allergic rhinitis to ragweed.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Placebo Comparator		Drug: Sublingual tablet of ragweed pollen allergen extract
2	Experimental		Drug: Sublingual tablet of ragweed pollen allergen extract

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sublingual tablet of ragweed pollen allergen extract	Drug	administered once a day over 10 days	1 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety, tolerability as indicated by adverse events and safety laboratory evaluation assessed every day over 2 weeks		2 weeks

Secondary Outcomes

Measure	Description	Time Frame
Immunological markers (IgE and IgG4)		2 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

written consent
male or female subjects from 18 yo 60 years old and in general good health
for women of child bearing potential: negative urine pregnancy test and use of medically effective contraceptive method
symptoms of ragweed pollen induced allergic rhinitis for at least the last 2 years
sensitization to ragweed pollen as demonstrated with positive skin prick test to ragweed pollen and specific IgE level (ragweed pollen) > 0.70 kU/l at screening
FEV1 at least of 80% of predicted value at screening

Exclusion Criteria:

past or current disease which, as judged by the investigator, may affect the outcome of this study
history of life-threatening asthma
asthma requiring daily treatment (whatever the pharmaceutical class)
pregnant or lactating women
subjects who previously received desensitisation treatment to ragweed pollen and/or other Asteraceae or who plan to start desensitisation treatment during this study
symptoms during the treatment phase due to a sensitivity to a second allergen
subjects treated with ongoing immunotherapy with another allergen

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eva Péterfai, MD	DRC Drug Research Center, Balatonfüred - Hungary	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
DRC Drug Research Center		Balatonfüred		H-8230	Hungary

Condition Browse Module

MeSH Terms

ID	Term
D006255	Rhinitis, Allergic, Seasonal
D006967	Hypersensitivity

Ancestor Terms

ID	Term
D065631	Rhinitis, Allergic
D012220	Rhinitis
D009668	Nose Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided