Trial | NCT01727973  Report issue

Title

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

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    14
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.
Study Started
Oct 31
2012
Primary Completion
Nov 30
2013
Study Completion
Nov 30
2013
Last Update
Dec 10
2013
Estimate

Drug Doxycycline

Tab. Doxycycline 50 mg PO per day for 12 weeks

  • Other names: Dolotard, Tibirox, Biomycin

Doxycycline Experimental

Tablets Doxycycline 50 mg PO per day for 12 weeks

Criteria 

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
No Results Posted