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

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: Doxycycline

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