Doxycycline Treatment in Mild Graves' Orbitopathy
Information source: Sun Yat-sen University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Graves Ophthalmopathy; Graves Disease; Eye Diseases; Thyroid Diseases; Endocrine System Diseases; Eye Diseases, Hereditary; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases
Intervention: Doxycycline (Drug); placebo (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Sun Yat-sen University Official(s) and/or principal investigator(s): Dan Liang, MD, Principal Investigator, Affiliation: Zhongsh Ophthalmic Center
Overall contact: Dan Liang, MD, Phone: 0086-20-87331766, Email: linml0754@gmail.com
Summary
The aim of this study is to evaluate the effects of subantimicrobial dose doxycycline (50
mg/d), administered for 12 weeks, on patients with mild Graves' Orbitopathy (GO).
Clinical Details
Official title: The Effect of Subantimicrobial Dose Doxycycline in Mild Graves' Orbitopathy
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Treatment response
Secondary outcome: Ocular surface disease index (OSDI)Safety and tolerability as assessed by adverse events, vital signs Health related quality of life questionnaires (GO-QoL)
Detailed description:
Graves'orbitopathy is an autoimmune disease that can be treated by corticosteroids and
surgery. But they often cause severe side-effects and are usually used for treating
moderate-sever and sight-threatening GO. Wait and see will be the first choice for the
patient with mild GO.
Subantimicrobial dose (SD) doxycycline displays a strong anti-inflammatory and
immunomodulatory function, which is independent of its antibiotic properties. Data from
clinical trials demonstrated that SD doxycycline was effective in moderating inflammation in
a variety of autoimmune diseases, such as rheumatoid arthritis, multiple sclerosis, rosacea
and periodontitis.
We propose to test the effect of subantimicrobial dose doxycycline for mild GO.
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Clinical diagnosis of Graves' Orbitopathy
- Mild GO According to EUGOGO statemnt, patients with mild GO usually have any one or
more of the following:mild soft tissue involvement, exophthalmos<18mm, temporary, or
no diplopia.
- Clinical activity score lower than 3
- Being euthyroid for at least 1 month before the date of inclusion
- No previous specific therapy for GO, except for local measures in 1 month before the
date of inclusion
- Written informed consent is obtained
Exclusion Criteria:
- moderate-sever Graves' Orbitopathy
- Sight-threatening Graves' Orbitopathy
- Clinical activity score ≥ 3
- Pregnant females as determined by positive (serum or urine) hCG test at screening or
prior to dosing, or lactating females
- Uncontrolled diabetes or hypertension
- History of mental / psychiatric disorder
- Hepatic dysfunction (Alb, AST, 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
Locations and Contacts
Dan Liang, MD, Phone: 0086-20-87331766, Email: linml0754@gmail.com
Zhongshan Ophthalmic Center, Guangzhou, Guangdong 510060, China; Recruiting Dan Liang, MD, Phone: 0086-20-87331766, Email: liangd2@mail.sysu.edu.cn
Additional Information
Starting date: July 2014
Last updated: July 28, 2014
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