Doxycycline Treatment in Mild Graves' Orbitopathy
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|ClinicalTrials.gov Identifier: NCT02203682|
Recruitment Status : Unknown
Verified July 2014 by Dan Liang, Sun Yat-sen University.
Recruitment status was: Recruiting
First Posted : July 30, 2014
Last Update Posted : July 30, 2014
|Condition or disease||Intervention/treatment||Phase|
|Graves Ophthalmopathy Graves Disease Eye Diseases Thyroid Diseases Endocrine System Diseases Eye Diseases, Hereditary Hyperthyroidism Autoimmune Diseases Immune System Diseases||Drug: Doxycycline Drug: placebo||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Effect of Subantimicrobial Dose Doxycycline in Mild Graves' Orbitopathy|
|Study Start Date :||July 2014|
|Estimated Primary Completion Date :||July 2015|
|Estimated Study Completion Date :||July 2015|
Tablets Doxycycline 50 mg PO per day for 12 weeks
Tab. Doxycycline 50 mg PO per day for 12 weeks
Placebo Comparator: Placebo
Tablet placebo for 12 weeks
Tablet placebo for 12 weeks
- Treatment response [ Time Frame: 12 weeks ]As definition of treatment response, we used four criteria: reduction of 2 mm or more in proptosis; improvement of ≥8 degrees in any direction of eye movements; reduction of 2 mm or more in eyelid aperture; improvement in grade of soft tissue swelling. A successful response was defined as an improvement in one or more 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. No success was defined if there was no change or the changes did not reach the success criteria.
- Ocular surface disease index (OSDI) [ Time Frame: 12 weeks ]
- Safety and tolerability as assessed by adverse events, vital signs [ Time Frame: 12 weeks ]
- Health related quality of life questionnaires (GO-QoL) [ Time Frame: 12 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02203682
|Contact: Dan Liang, MDfirstname.lastname@example.org|
|Zhongshan Ophthalmic Center||Recruiting|
|Guangzhou, Guangdong, China, 510060|
|Contact: Dan Liang, MD 0086-20-87331766 email@example.com|
|Principal Investigator:||Dan Liang, MD||Zhongsh Ophthalmic Center|