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Prednisone Versus Doxycycline in the Treatment of Graves' Orbitopathy

NCT01809444 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2013-12-10

No results posted yet for this study

Summary

The aim of this study is to compare the efficacy and safety of prednisone versus sub-antimicrobial dose doxycycline (50 mg/d) in the treatment of active moderate-severe Graves' Orbitopathy (GO).

Conditions

  • Thyroid Associated Opthalmopathies

Interventions

DRUG

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

DRUG

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.

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Dan Liang, MD · Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China

  • Liya Wang, MD · Henan Eye Institue, Henan, China

  • Luosheng Tang, MD · The second xiangya hospital of central south university, Hunan, China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2016-01-31
Completion
2016-01-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01809444 on ClinicalTrials.gov