Prednisone Versus Doxycycline in the Treatment of Graves' Orbitopathy
NCT ID: NCT01809444
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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UNKNOWN
PHASE2/PHASE3
146 participants
INTERVENTIONAL
2012-11-30
2016-01-31
Brief Summary
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Detailed Description
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Sub-antimicrobial 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 sub-antimicrobial dose doxycycline for treating inflammatory or autoimmune diseases, such as rosacea, periodontitis and multiple sclerosis. The mechanism is by inhibiting lymphocyte proliferation and production of colony-stimulating factor, inflammatory cytokines, and immunoglobulins, factors thought to play a role in the orbital autoimmune process. These mechanisms make them, in theory, an attractive option of doxycycline for treating Graves' Orbitopathy. In addition, only few adverse events were reported when doxycycline were administered for 3 months in patients with periodontitis or rosacea.
We propose to compare the effect and safety of sub-antimicrobial dose doxycycline versus prednisone for treating non-sight threatening, moderate-severe, inflammatory GO.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Prednisone+placebo of Doxycycline
Prednisone: 50 mg/d for 14 day, tailed by 40 mg/d for 14 day, 30 mg/d for 28 day, 20 mg/d for 28 day, 15 mg/d for 14 day, 10 mg/d for 14 day, in total 16 weeks; Placebo of doxycycline: administered for 16 weeks.
Prednisone+placebo of Doxycycline
Prednisone: 50 mg/d for 14 day, tailed by 40 mg/d for 14 day, 30 mg/d for 28 day, 20 mg/d for 28 day, 15 mg/d for 14 day, 10 mg/d for 14 day, in total 16 weeks; Placebo of doxycycline: administered for 16 weeks
Doxycycline+placebo of Prednisone
Doxycycline: 50 mg/d for 12 weeks, and placebo for another 4 weeks; Placebo of prednisone: administered for 16 weeks.
Doxycycline+placebo of Prednisone
Doxycycline: 50 mg PO per day for 12 weeks, and placebo for another 4 weeks; Placebo of prednisone: administered for 16 weeks.
Interventions
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Prednisone+placebo of Doxycycline
Prednisone: 50 mg/d for 14 day, tailed by 40 mg/d for 14 day, 30 mg/d for 28 day, 20 mg/d for 28 day, 15 mg/d for 14 day, 10 mg/d for 14 day, in total 16 weeks; Placebo of doxycycline: administered for 16 weeks
Doxycycline+placebo of Prednisone
Doxycycline: 50 mg PO per day for 12 weeks, and placebo for another 4 weeks; Placebo of prednisone: administered for 16 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Eyelid retraction (upper eyelid margin at or above the superior corneoscleral limbus in primary gaze without frontalis muscle contraction) in association with any one of the following:
* Thyroid dysfunction or abnormal regulation (increased serum thyroxine or triiodothyronine level, decreased serum thyroid stimulating hormone level, absence of thyroid radioiodine uptake suppression after administration of triiodothyronine, or the presence of thyroid stimulating immunoglobulins in serum)
* Exophthalmos
* Extraocular muscle involvement (restrictive myopathy or objective evidence of enlarged muscles)
* Optic nerve dysfunction (abnormal visual acuity, color vision, pupillary reaction or perimetry not attributable to other causes) OR
* Thyroid dysfunction or abnormal regulation in association with any one of the following:
* Exophthalmos
* Extraocular muscle involvement
* Optic nerve dysfunction
* Moderate-severe GO According to EUGOGO statement, patients with moderate-severe GO usually have any one or more of the following：lid retraction≥2mm, 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 months 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 gonadotrophin (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 Aminotransferase (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 or Prednisone 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
Zhongshan Ophthalmic Center
Principal Investigators
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Dan Liang, MD
Role: STUDY_CHAIR
Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China
Liya Wang, MD
Role: PRINCIPAL_INVESTIGATOR
Henan Eye Institue, Henan, China
Luosheng Tang, MD
Role: PRINCIPAL_INVESTIGATOR
The second xiangya hospital of central south university, Hunan, China
Locations
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Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Zhongshan Ophthalmic Center
Guangzhou, Guangdong, China
JOINT SHANTOU INTERNATIONALL EYE CENTER of Shantou University and the Chinese University of Hong Kong
Shantou, Guangdong, China
Shenzhen Eye Hospital
Shenzhen, Guangdong, China
Henan Eye Institue, Henan, China
Zhengzhou, Henan, China
The second xiangya hospital of central south university
Changsha, Hunan, China
Countries
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Central Contacts
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Facility Contacts
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Yong Zhong, MD
Role: primary
Dan Liang, MD
Role: primary
Mingzhi Zhang, MD
Role: primary
Guiqin Liu, MD
Role: primary
Liya wang, MD
Role: primary
Wei Xiong, MD
Role: primary
Related Links
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Genetics Home Reference related topics: Lenz microphthalmia syndrome oculofacioc
MedlinePlus related topics: Antibiotics Eye Diseases Thyroid Diseases
U.S. FDA Resources
Other Identifiers
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5010-doxy
Identifier Type: -
Identifier Source: org_study_id