Autoimmune Diseases Clinical Trial
Official title:
Efficacy of Subantimicrobial Dose Doxycycline for Moderate to Severe and Active Graves' Orbitopathy: a Prospective, Uncontrolled Pilot Study
Verified date | December 2013 |
Source | Sun Yat-sen University |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Ethics Committee |
Study type | Interventional |
The aim of this study is to evaluate the effects of subantimicrobial dose doxycycline (50 mg/d), administered for 12 wk, for patients with active moderate-severe Graves' Orbitopathy (GO).
Status | Completed |
Enrollment | 14 |
Est. completion date | November 2013 |
Est. primary completion date | November 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Clinical diagnosis of Graves' Orbitopathy - Moderate-severe GO According to EUGOGO statements, patients with moderate-severe GO usually have any one or more of the following:moderate or severe soft tissue involvement, exophthalmos=3mm above normal for race and gender, inconstant, or constant diplopia. - Clinical activity score = 3 - Being euthyroid for at least 1 month before the date of inclusion - Must be able to swallow tablets - Written informed consent is obtained Exclusion Criteria: - Mild Graves' Orbitopathy - Sight-threatening Graves' Orbitopathy - Clinical activity score < 3 - Previous treatment for GO Oral steroids, intravenous steroids, radiotherapy - Pregnant females as determined by positive (serum or urine) Human chorionic gonadotropin (hCG) test at screening or prior to dosing, or lactating females - Uncontrolled diabetes or hypertension - History of mental / psychiatric disorder - Hepatic dysfunction (Albumin (Alb),Aspartate Transaminase (AST), Alanine Aminotransferase (ALT) and Alkaline phosphates levels must be within normal range for eligibility) - Renal impairment (Urea and Creatinine levels must be within normal range) - Doxycycline allergy or intolerance |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Zhongshan Ophthalmic Center | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Sun Yat-sen University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | • Treatment response | As definition of treatment response, we used the major and minor criteria . Three major criteria were: improvement in diplopia grade (disappearance or change in grade); improvement of =8 degrees in any direction of eye movements; reduction of three points or more in CAS. Four minor criteria were: reduction of 2 mm or more in eyelid aperture; reduction of 2 mm or more in proptosis; improvement in grade of soft tissue swelling; decrease in CAS by at least two points. A successful response was defined as an improvement in one or more major criteria or in two minor criteria, in absence of deterioration of any criterion in that observed eye. Deterioration was defined as occurrence of DON, and/or worsening of soft tissue swelling, and/or worsening of diplopia, and/or an increase of =2 mm in lid aperture, and/or an increase of =2 mm in proptosis, and/or a decrease of =8 degrees in duction. No success was defined if there was no change or the changes did not reach the success criteria. | 24 weeks | No |
Secondary | Safety and tolerability as assessed by adverse events, vital signs | 24 weeks | Yes | |
Secondary | Graves' orbitopathy-Specific Quality of Life (GO-QoL) | 24 weeks | No |
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