NCT00718744

Brief Summary

The main purpose of the trial is to prove the therapeutic value of the product and enable an effective and safe dosage schedule to be recommended

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2008

Shorter than P25 for phase_2

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

June 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 21, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

August 5, 2010

Status Verified

August 1, 2010

Enrollment Period

5 months

First QC Date

July 17, 2008

Last Update Submit

August 4, 2010

Conditions

Rhinitis, Allergic, SeasonalConjunctivitis, Allergic

Keywords

Allergen-extractStandardization

Outcome Measures

Primary Outcomes (1)

  • Wheal size area (mm2) of the immediate phase reaction.

    30 minutes per subject

Study Arms (1)

A

EXPERIMENTAL

In each individual patient, 10 mg/ml histamine dihydrochloride solution and a phenolated saline solution will be applied as positive and negative control respectively.

Other: Standardization of allergenic extract (Ch. arcuatus)

Interventions

Standardization of allergenic extract (Ch. arcuatus)OTHER

Allergenic extract for cutaneous prick-test

A

Eligibility Criteria

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

You may qualify if:

  • Voluntarily signed informed consent form by the patient
  • Patients should live in a geographic zone where allergy caused by Chortoglyphus arcuatus is a relevant problem.
  • A positive case history with inhalant allergy related to exposure to the allergen to be tested.
  • A positive prick test (mean wheal diameter \> 3 mm) when tested with a standardized extract prepared from the allergen source in question and/or a positive test for specific IgE.
  • A mean wheal diameter \> 7 mm2 obtained in a prick test with histamine dihydrochloride 10 mg/ml.
  • Age: 18-50 years.
  • Both genders

You may not qualify if:

  • Immunotherapy in the past 2 years with an allergen preparation known to interfere with the allergens to be tested.
  • Use of drugs that may interfere with the skin reactions.
  • Pregnancy
  • Dermographism
  • Atopic dermatitis (locally at the test site)
  • Urticaria.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital "Xeral de Calde"

Calde, Lugo, 27004, Spain

Location

MeSH Terms

Conditions

Rhinitis, Allergic, SeasonalConjunctivitis, Allergic

Condition Hierarchy (Ancestors)

Rhinitis, AllergicRhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System DiseasesConjunctivitisConjunctival DiseasesEye Diseases

Study Officials

  • Manuel Boquete, MD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 17, 2008

First Posted

July 21, 2008

Study Start

June 1, 2008

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

August 5, 2010

Record last verified: 2010-08

Locations

ES(1)