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Doxycycline Treatment in Graves' Orbitopathy

This study is currently recruiting participants.
Verified February 2013 by Sun Yat-sen University
Sponsor:
Information provided by (Responsible Party):
Dan Liang, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01727973
First received: November 12, 2012
Last updated: February 15, 2013
Last verified: February 2013
History of Changes
  Purpose

The aim of this study is to evaluate the effects of subantimicrobial dose doxycycline (50 mg/d), administered three months, for patients with active moderate-severe Graves' Orbitopathy (GO).


Condition Intervention Phase
Graves Ophthalmopathy
Graves Disease
Eye Diseases
Thyroid Diseases
Endocrine System Diseases
Eye Diseases, Hereditary
Hyperthyroidism
Autoimmune Diseases
Immune System Diseases
 Drug: Doxycycline
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Subantimicrobial Dose Doxycycline in Graves' Orbitopathy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • • European Group on Graves' Orbitopathy (EUGOGO) Clinical Activity Score [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • • Health related quality of life questionnaires (GO-QoL) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • • Safety and tolerability as assessed by adverse events, vital signs [ Time Frame: 6 months. ] [ Designated as safety issue: Yes ]
  • Relapse [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 14
Study Start Date: October 2012
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Doxycycline
Tablets Doxycycline 50 mg PO per day for three months
 Drug: Doxycycline
Tab. Doxycycline 50 mg PO per day for 3 months
Other Names:
  • Dolotard
  • Tibirox
  • Biomycin

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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：lid retraction≥2mm, moderate or severe soft tissue involvement, exophthalmos≥3mm above normal for race and gender, inconstant, or constant diplopia.
  • Clinical activity score higher than 4
  • Being euthyroid for at least 2 months 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 less than 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01727973

Contacts
Contact: Dan Liang, MD 0086-20-87331766 linml0754@gmail.com

Locations
China, Guangdong
Zhongshan Ophthalmic Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Dan Liang, MD     0086-20-87331766     liangd2@mail.sysu.edu.cn    
Principal Investigator: Dan Liang, MD            
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Principal Investigator: Dan Liang, MD Zhongsh Ophthalmic Center
  More Information

Additional Information:
Genetics Home Reference related topics: Lenz microphthalmia syndrome oculofaciocardiodental syndrome Peters plus syndrome  This link exits the ClinicalTrials.gov site
MedlinePlus related topics: Antibiotics Eye Diseases Thyroid Diseases  This link exits the ClinicalTrials.gov site
Drug Information available for: Doxycycline Dolotard Tibirox Biomycin  This link exits the ClinicalTrials.gov site
U.S. FDA Resources  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Dan Liang, MD, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01727973     History of Changes
Other Study ID Numbers: GO-DOXY-1
Study First Received: November 12, 2012
Last Updated: February 15, 2013
Health Authority: China: Ethics Committee

Keywords provided by Sun Yat-sen University:
Graves' orbitopathy
Graves´ ophthalmopathy
Thyroid eye disease
Thyroid-associated ophthalmopathy
 Doxycycline
EUGOGO
CAS

Additional relevant MeSH terms:
Autoimmune Diseases
Endocrine System Diseases
Eye Diseases
Eye Diseases, Hereditary
Graves Disease
Genetic Diseases, Inborn
Hyperthyroidism
Immune System Diseases
Thyroid Diseases
Graves Ophthalmopathy
Exophthalmos
 Orbital Diseases
Goiter
Doxycycline
Doxycycline hyclate
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on May 16, 2013