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Hydroxychloroquine Efficacy in Chronic Urticaria

Primary Purpose

Chronic Urticaria

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Placebo
Hydroxychloroquine
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Urticaria focused on measuring Chronic Urticaria, Hives, Hydroxychloroquine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Inclusion:

    1. Age >18, Age<65
    2. Chronic Urticaria refractory to treatment with standard anti-histamines
    3. Minimum Urticaria Score

Exclusion Criteria:

  • Exclusion:

    1. Pregnancy
    2. Vasculitis
    3. Trigger Induced Urticaria
    4. Food intolerance
    5. Malignancy
    6. Kidney or liver dysfunction
    7. Systemic diseases
    8. Hypersensitivity to hydroxychloroquine

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Active Comparator

    Arm Label

    Placebo

    Hydroxychloroquine

    Arm Description

    Patients will be taking placebo medication throughout study.

    Patients will be taking hydroxychloroquine throughout study.

    Outcomes

    Primary Outcome Measures

    Urticarial Symptom Score

    Secondary Outcome Measures

    Difference in Basophil Activation
    Difference in Rescue Medication Usage
    Difference in Dermatology Life Quality Index

    Full Information

    First Posted
    February 22, 2010
    Last Updated
    January 21, 2013
    Sponsor
    Vanderbilt University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01073852
    Brief Title
    Hydroxychloroquine Efficacy in Chronic Urticaria
    Official Title
    Hydroxychloroquine Efficacy in Chronic Urticaria
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2013
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    withdrawn, not funded
    Study Start Date
    June 2011 (undefined)
    Primary Completion Date
    June 2012 (Actual)
    Study Completion Date
    June 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Vanderbilt University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    Detailed Description
    Our research question is: Is hydroxychloroquine an efficacious medicine to use in patients with chronic urticaria? Answering this question should help allergists treat chronic urticaria with a more evidence based approach. To date there has one been one prospective trial evaluating hydroxychloroquine in hives, and although it showed a trend towards efficacy (0.05<p<0.10), it was not statistically significant. There have been case series, and anecdotal reports which seem to demonstrate efficacy of chloroquine in chronic urticaria. Because of these reports hydroxychloroquine is often the first medication used in patients with chronic hives that are refractory to standard therapy of antihistamines. We believe an evidence based answer to this question will be an important step towards improved treatment of this disease. We plan to ascertain the efficacy of hydroxychloroquine by completing a randomized double blinded placebo controlled study of treatment in patients with chronic urticaria. We will be measuring an Urticarial Score to evaluate hive symptoms. We will be measuring them at baseline, and at the end of the study to note change in drug vs placebo.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Urticaria
    Keywords
    Chronic Urticaria, Hives, Hydroxychloroquine

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Patients will be taking placebo medication throughout study.
    Arm Title
    Hydroxychloroquine
    Arm Type
    Active Comparator
    Arm Description
    Patients will be taking hydroxychloroquine throughout study.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo pill, 1 pill orally twice daily for 9 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Hydroxychloroquine
    Intervention Description
    Patients will be taking hydroxychloroquine 200mg orally twice/daily.
    Primary Outcome Measure Information:
    Title
    Urticarial Symptom Score
    Time Frame
    10 weeks
    Secondary Outcome Measure Information:
    Title
    Difference in Basophil Activation
    Time Frame
    10 weeks
    Title
    Difference in Rescue Medication Usage
    Time Frame
    10 weeks
    Title
    Difference in Dermatology Life Quality Index
    Time Frame
    10 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Inclusion: Age >18, Age<65 Chronic Urticaria refractory to treatment with standard anti-histamines Minimum Urticaria Score Exclusion Criteria: Exclusion: Pregnancy Vasculitis Trigger Induced Urticaria Food intolerance Malignancy Kidney or liver dysfunction Systemic diseases Hypersensitivity to hydroxychloroquine
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pogie Pongonis, MD
    Organizational Affiliation
    Vanderbilt University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    John Fahrenholz, MD
    Organizational Affiliation
    Vanderbilt University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    15086698
    Citation
    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.
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