Hydroxychloroquine Efficacy in Chronic Urticaria
Primary Purpose
Chronic Urticaria
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Placebo
Hydroxychloroquine
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Urticaria focused on measuring Chronic Urticaria, Hives, Hydroxychloroquine
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
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
NCT ID
NCT01073852
First Posted
February 22, 2010
Last Updated
January 21, 2013
Sponsor
Vanderbilt University
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Withdrawn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withdrawn, not funded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.
Results Reference
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Hydroxychloroquine Efficacy in Chronic Urticaria
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