Efficacy and Safety From a High-dosed Sublingual Grass Po... | NCT00623701

Studies
Efficacy and Safety From a High-dosed Sublingual Grass Pollen Preparation

NCT00623701

Sponsor

Allergopharma GmbH & Co. KG

Status

Completed

Last Update Posted

Nov 8, 2013Estimated

Enrollment

126Actual

Phase

Phase 3

Conditions

Allergy
Rhinitis
Conjunctivitis

Interventions

Allerslit forte
Allerslit forte

Countries

Germany

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

ID	Type	Description	Link
2007-000823-16	EudraCT Number

Status Module

Record Verification Date

Nov 2013

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

Mar 2008

Primary Completion Date

Oct 2011Actual

Completion Date

Oct 2012Actual

First Submitted Date

Feb 19, 2008

First Submission Date that Met QC Criteria

Feb 25, 2008

First Posted Date

Feb 26, 2008Estimated

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 7, 2013

Last Update Posted Date

Nov 8, 2013Estimated

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

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

126Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Placebo Comparator	sublingual placebo preparation	Biological: Allerslit forte
2	Experimental	Sublingual preparation, 40 micro grams Phl p 5 maintenance dose	Biological: Allerslit forte

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Allerslit forte	Biological	sublingual placebo preparation, daily	1

Measure	Description	Time Frame
Symptom and Medication Score		Grass pollen season 2009

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Allergic rhinoconjunctivitis attributable to grass pollen
Positive SPT
Positive EAST
Positive provocation Test

Exclusion Criteria:

Serious chronic disease
other perennial allergies

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kristian Reich, Professor	not affiliated	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Prof. Kristian Reich, MD		Hamburg		20354	Germany

References Module

Citations

Not provided

Label	URL
Leader in specific allergy research and therapy	View source
Click here for information about this trial in the European Clinical Trials Register	View source

ID	Term
D006967	Hypersensitivity
D012220	Rhinitis
D003231	Conjunctivitis

ID	Term
D007154	Immune System Diseases
D012141	Respiratory Tract Infections
D007239	Infections
D009668	Nose Diseases