NCT01073852

Brief Summary

This study is for those people with difficult to treat hives. We are investigating whether or not a different medication, hydroxychloroquine, works to treat a certain type of hives. Hydrochloroquine is currently approved by the Food and Drug Administration (FDA), for treating arthritis, therefore it is considered investigational in this study. Hypothesis: Hydroxychloroquine will prove to have an efficacious response in terms of Urticarial Symptoms, on patients with chronic urticaria.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2011

Status
withdrawn

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

First Submitted

Initial submission to the registry

February 22, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 23, 2010

Completed
1.3 years until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

January 23, 2013

Status Verified

January 1, 2013

Enrollment Period

1 year

First QC Date

February 22, 2010

Last Update Submit

January 21, 2013

Conditions

Chronic Urticaria

Keywords

Chronic UrticariaHivesHydroxychloroquine

Outcome Measures

Primary Outcomes (1)

  • Urticarial Symptom Score

    10 weeks

Secondary Outcomes (3)

  • Difference in Basophil Activation

    10 weeks

  • Difference in Rescue Medication Usage

    10 weeks

  • Difference in Dermatology Life Quality Index

    10 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Patients will be taking placebo medication throughout study.

Drug: Placebo

Hydroxychloroquine

ACTIVE COMPARATOR

Patients will be taking hydroxychloroquine throughout study.

Drug: Hydroxychloroquine

Interventions

PlaceboDRUG

Placebo pill, 1 pill orally twice daily for 9 weeks.

Placebo
HydroxychloroquineDRUG

Patients will be taking hydroxychloroquine 200mg orally twice/daily.

Hydroxychloroquine

Eligibility Criteria

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

You may qualify if:

  • Age \>18, Age\<65
  • Chronic Urticaria refractory to treatment with standard anti-histamines
  • Minimum Urticaria Score

You may not qualify if:

  • Pregnancy
  • Vasculitis
  • Trigger Induced Urticaria
  • Food intolerance
  • Malignancy
  • Kidney or liver dysfunction
  • Systemic diseases
  • Hypersensitivity to hydroxychloroquine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Reeves GE, Boyle MJ, Bonfield J, Dobson P, Loewenthal M. Impact of hydroxychloroquine therapy on chronic urticaria: chronic autoimmune urticaria study and evaluation. Intern Med J. 2004 Apr;34(4):182-6. doi: 10.1111/j.1444-0903.2004.00532.x.

    PMID: 15086698BACKGROUND

MeSH Terms

Conditions

Chronic UrticariaUrticaria

Interventions

Hydroxychloroquine

Condition Hierarchy (Ancestors)

Skin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesHypersensitivity, ImmediateHypersensitivityImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ChloroquineAminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Pogie Pongonis, MD

    Vanderbilt University

    PRINCIPAL INVESTIGATOR

  • John Fahrenholz, MD

    Vanderbilt University

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 22, 2010

First Posted

February 23, 2010

Study Start

June 1, 2011

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

January 23, 2013

Record last verified: 2013-01