NCT00421655

Brief Summary

The trial is performed to evaluate the efficacy and safety of specific immunotherapy with Grazax for treatment of grass pollen induced allergy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
329

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Dec 2006

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 11, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 12, 2007

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

June 24, 2015

Status Verified

June 1, 2015

Enrollment Period

8 months

First QC Date

January 11, 2007

Last Update Submit

June 23, 2015

Conditions

Allergy

Outcome Measures

Primary Outcomes (1)

  • Recording of allergy symptoms

    Grass pollen season 2007

Study Arms (2)

1

EXPERIMENTAL
Drug: Grazax

2

PLACEBO COMPARATOR
Drug: Grazax

Interventions

GrazaxDRUG

Tablets 75,000 SQT and matching placebo. One tablet daily.

12

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • History of grass pollen allergy
  • Positive skin prick test to grass
  • Positive specific IgE to grass

You may not qualify if:

  • FEV1 \<70% of predicted value

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CompleWare Corporation

Iowa City, Iowa, 52244-3090, United States

Location

Related Publications (1)

  • Murphy K, Gawchik S, Bernstein D, Andersen J, Pedersen MR. A phase 3 trial assessing the efficacy and safety of grass allergy immunotherapy tablet in subjects with grass pollen-induced allergic rhinitis with or without conjunctivitis, with or without asthma. J Negat Results Biomed. 2013 Jun 1;12:10. doi: 10.1186/1477-5751-12-10.

    PMID: 23725348DERIVED

MeSH Terms

Conditions

Hypersensitivity

Interventions

Grazax

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

  • Kim Simonsen, MD

    ALK-Abelló A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 11, 2007

First Posted

January 12, 2007

Study Start

December 1, 2006

Primary Completion

August 1, 2007

Study Completion

October 1, 2007

Last Updated

June 24, 2015

Record last verified: 2015-06

Locations

US(1)