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Efficacy of Subantimicrobial Dose Doxycycline for Moderate to Severe and Active Graves' Orbitopathy

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ClinicalTrials.gov Identifier: NCT01727973
Recruitment Status : Completed
First Posted : November 16, 2012
Last Update Posted : December 10, 2013
Sponsor:
Information provided by (Responsible Party):

November 12, 2012
November 16, 2012
December 10, 2013
October 2012
November 2013   (Final data collection date for primary outcome measure)
• Treatment response [ Time Frame: 24 weeks ]
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.
• European Group on Graves' Orbitopathy (EUGOGO) Clinical Activity Score [ Time Frame: Primary study measures - 6 months ]
Clinical Activity Score is a validated index of Graves' orbitopathy that assigns one point to the presence of: 1.spontaneous retrobulbar pain, 2. pain on up/downgaze, 3. redness of eyelids, 4. redness of conjunctiva, 5. swelling of eyelids, 6. inflammation of caruncle/plica, 7. chemosis. The maximal clinical activity score (CAS) is thus 7.
Complete list of historical versions of study NCT01727973 on ClinicalTrials.gov Archive Site
  • Safety and tolerability as assessed by adverse events, vital signs [ Time Frame: 24 weeks ]
  • Graves' orbitopathy-Specific Quality of Life (GO-QoL) [ Time Frame: 24 weeks ]
• Health related quality of life questionnaires (GO-QoL) [ Time Frame: Primary study measures - 6 months ]
Not Provided
• Safety and tolerability as assessed by adverse events, vital signs [ Time Frame: Time Frame: Primary study measures - 6 months. ]
 
Efficacy of Subantimicrobial Dose Doxycycline for Moderate to Severe and Active Graves' Orbitopathy
Efficacy of Subantimicrobial Dose Doxycycline for Moderate to Severe and Active Graves' Orbitopathy: a Prospective, Uncontrolled Pilot Study
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).

Graves'orbitopathy is an autoimmune disease characterised by an inflammatory phase followed by fibrosis. Surgery to correct eyelid swelling, proptosis, and diplopia is effective, but can not be done until the inflammatory phase has passed. To arrest the inflammatory phase, several types of immunosuppressive treatments have been investigated. Corticosteroids are the first-choice immunosuppressive treatment, but they often cause severe side-effects.

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.

Interventional
Phase 1
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Graves Ophthalmopathy
  • Graves Disease
  • Eye Diseases
  • Thyroid Diseases
  • Endocrine System Diseases
  • Eye Diseases, Hereditary
  • Hyperthyroidism
  • Autoimmune Diseases
  • Immune System Diseases
Drug: Doxycycline
Tab. Doxycycline 50 mg PO per day for 12 weeks
Other Names:
  • Dolotard
  • Tibirox
  • Biomycin
Experimental: Doxycycline
Tablets Doxycycline 50 mg PO per day for 12 weeks
Intervention: Drug: Doxycycline
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
November 2013
November 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01727973
GO-DOXY-1
Yes
Not Provided
Not Provided
Dan Liang, Sun Yat-sen University
Sun Yat-sen University
Not Provided
Principal Investigator: Dan Liang, MD Zhongsh Ophthalmic Center
Sun Yat-sen University
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP