Hydroxychloroquine Efficacy in Chronic Urticaria

NCT ID: NCT01073852

Last Updated: 2013-01-23

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2012-06-30

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.

Conditions

Chronic Urticaria

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo

Patients will be taking placebo medication throughout study.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Hydroxychloroquine

Patients will be taking hydroxychloroquine throughout study.

Group Type: ACTIVE_COMPARATOR

Hydroxychloroquine

Intervention Type: DRUG

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

Interventions

Placebo

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

Intervention Type: DRUG

Hydroxychloroquine

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University

OTHER

Sponsor Role: lead

Responsible Party

John Michael Fahrenholz

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pogie Pongonis, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University

John Fahrenholz, MD

Role: STUDY_DIRECTOR

Vanderbilt University

References

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.

Reference Type: BACKGROUND

PMID: 15086698 (View on PubMed)

Other Identifiers

Pending

Identifier Type: -

Identifier Source: org_study_id