Efficacy of Subantimicrobial Dose Doxycycline for Moderate to Severe and Active Graves' Orbitopathy
NCT ID: NCT01727973
Last Updated: 2013-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
14 participants
INTERVENTIONAL
2012-10-31
2013-11-30
Brief Summary
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Detailed Description
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Subantimicrobial dose doxycycline posses known anti-inflammatory effects that are separate from their antibacterial mode of action. This mode of action has lead to the routine use of subantimicrobial dose doxycycline for rosacea, periodontitis and multiple sclerosis.
We propose to test the effect of subantimicrobial dose doxycycline for non-sight threatening, moderate-severe, inflammatory GO.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Doxycycline
Tablets Doxycycline 50 mg PO per day for 12 weeks
Doxycycline
Tab. Doxycycline 50 mg PO per day for 12 weeks
Interventions
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Doxycycline
Tab. Doxycycline 50 mg PO per day for 12 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
60 Years
ALL
No
Sponsors
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Sun Yat-sen University
OTHER
Responsible Party
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Dan Liang
MD
Principal Investigators
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Dan Liang, MD
Role: PRINCIPAL_INVESTIGATOR
Zhongsh Ophthalmic Center
Locations
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Zhongshan Ophthalmic Center
Guangzhou, Guangdong, China
Countries
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References
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Lin M, Mao Y, Ai S, Liu G, Zhang J, Yan J, Yang H, Li A, Zou Y, Liang D. Efficacy of Subantimicrobial Dose Doxycycline for Moderate-to-Severe and Active Graves' Orbitopathy. Int J Endocrinol. 2015;2015:285698. doi: 10.1155/2015/285698. Epub 2015 Jun 29.
Related Links
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Genetics Home Reference related topics: Lenz microphthalmia syndrome oculofaciocardiodental syndrome Peters plus syndrome
MedlinePlus related topics: Antibiotics Eye Diseases Thyroid Diseases
Drug Information available for: Doxycycline Dolotard Tibirox Biomycin
U.S. FDA Resources
Other Identifiers
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GO-DOXY-1
Identifier Type: -
Identifier Source: org_study_id