Tolerability of ALK Grass Tablet in Children | NCT00310453

Studies
Tolerability of ALK Grass Tablet in Children

NCT00310453

Sponsor

ALK-Abelló A/S

Status

Completed

Last Update Posted

May 4, 2006Estimated

Enrollment

Phase

Phase 1

Conditions

Allergy

Interventions

ALK Grass tablet

Countries

Spain

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

May 2006

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 2006

Primary Completion Date

Not provided

Completion Date

May 2006

First Submitted Date

Apr 2, 2006

First Submission Date that Met QC Criteria

Apr 2, 2006

First Posted Date

Apr 4, 2006Estimated

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

May 3, 2006

Last Update Posted Date

May 4, 2006Estimated

Description Module

Brief Summary

The purpose of this trial is to assess whether the ALK Grass tablet treatment is safe to use in children aged 5-12 years

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

Name	Type	Description	Arm Group Labels	Other Names
ALK Grass tablet	Biological

Measure	Description	Time Frame
Assessment of safety by recording of adverse events

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Grass pollen induced rhinoconjunctivitis
Boys and girls, 5-12 years of age
Positive skin prick test to grass pollen

Exclusion Criteria:

Severe asthma
Previous treatment with immunotherapy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kim Simonsen, MD	ALK-Abelló A/S, Boege Alle 6-8, 2970 Hoersholm, Denmark	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Servicio de Alergia, Hospital del Niño Jesús		Madrid		28040	Spain