NCT00330083

Brief Summary

This trial is performed to assess whether ALK Ragweed Tablet is safe to use in adults

Trial Health

80
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P75+ for phase_1

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

May 1, 2006

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

May 23, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 25, 2006

Completed
Last Updated

September 21, 2007

Status Verified

September 1, 2007

First QC Date

May 23, 2006

Last Update Submit

September 20, 2007

Conditions

Allergy

Outcome Measures

Primary Outcomes (1)

  • Assessment of safety by recording of adverse events

Interventions

ALK Ragweed TabletBIOLOGICAL

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Ragweed pollen induced rhinoconjunctivitis
  • Adults of either sex (18-50 years of age)
  • Positive skin prick test to ragweed

You may not qualify if:

  • Previous treatment with immunotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Healthcare Discoveries Inc.

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

  • Christensen LH, Ipsen H, Nolte H, Maloney J, Nelson HS, Weber R, Lund K. Short ragweeds is highly cross-reactive with other ragweeds. Ann Allergy Asthma Immunol. 2015 Dec;115(6):490-495.e1. doi: 10.1016/j.anai.2015.09.016. Epub 2015 Oct 21.

    PMID: 26507708DERIVED

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

  • George J. Atiee, MD

    Healthcare Discoveries Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 23, 2006

First Posted

May 25, 2006

Study Start

May 1, 2006

Last Updated

September 21, 2007

Record last verified: 2007-09

Locations

US(1)