Bromocriptine and Pentoxifylline in Ophthalmopathy Autoimmune Treatment

NCT01893450 | Terminated

• 1 other identifier: DIA19508091
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

Autoimmune ophthalmopathy is clinically evident in one third of Graves' disease cases. In most cases it is mild; however, in 3 to 5% of cases it has a severe presentation. At present, the treatment is directed to identify vision threatening which requires aggressive intervention, usually with glucocorticoids. For mild cases the treatment is limited to the normalization of hyperthyroidism and support measures. Preliminary data show that pentoxifylline and bromocriptine may have a favorable effect in the course of ophthalmopathy by inhibition of the synthesis of TNF-α, VEGF, glycosaminoglycan production, and lymphocyte infiltration. Therefore, the aims of this study were to evaluate the effect of bromocriptine and pentoxifylline on the clinical course and quality of life of patients with mild to moderate ophthalmopathy associated to Graves´disease. Methods. Patients with mild to moderate ophthalmopathy, with less than one year of evolution, and naive to treatment were randomized to receive treatment during 12 months with either 1) bromocriptine (5 mg twice a day) + methimazole (30 mg/day), 2) pentoxifylline (400 mg twice a day) + methimazole (30 mg/day), or 3) methimazole only (30 mg/day). They completed 10 visits to evaluate proptosis and clinical activity score (CAS). In addition, in the first and last visit the quality of life questionnaire specific for Graves' ophthalmopathy(GO-QOL) was applied.

Conditions

Graves Ophthalmopathy

Keywords

Graves ophthalmopathy; Exophthalmos; Proptosis; Quality of life

Outcome Measures

Primary Outcomes (1)

• Proptosis

  Left and right eye proptosis by exophthalmometry

  One year

Secondary Outcomes (2)

• Clinical activity score

  One year

• Quality of life

  One year

Study Arms (3)

methimazole

ACTIVE COMPARATOR

methimazole 30 mg daily during one year

Drug: Methimazole

methimazole, bromocriptine

ACTIVE COMPARATOR

methimazole 30 mg daily during one year, bromocriptine 5 mg twice a day during one year

Drug: Bromocriptine

pentoxifylline

ACTIVE COMPARATOR

methimazol 30 mg daily and pentoxifylline 400 mg twice a day during one year

Drug: Pentoxifylline

Interventions

Methimazole DRUG

methimazole

Bromocriptine DRUG

methimazole, bromocriptine

Pentoxifylline DRUG

pentoxifylline

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women or men
• Between 18 and 45 years
• Autoimmune hyperthyroidism with one year or less of evolution
• No previous treatment
• Mild to moderate ophthalmopathy

You may not qualify if:

• Smoking
• Severe ophthalmopathy
• Steroid treatment
• Asthma
• Diabetes or other significant disease
• Creatine \>1.5 mg/dl
• Women with child bearing potential not using a birth control method
• Opthalmologic diseases
• Uncontrolled hypertension
• History of ischemic cardiopathy
• History of stroke
• History of gastrointestinal bleeding

Sponsors & Collaborators

• Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran: lead

Study Sites (1)

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Mexico City, Mexico City, 14000, Mexico

Location

MeSH Terms

Conditions

Graves Ophthalmopathy; Exophthalmos

Interventions

Methimazole; Bromocriptine; Pentoxifylline

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Graves Disease; Orbital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Sulfhydryl Compounds; Sulfur Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ergotamines; Ergot Alkaloids; Alkaloids; Ergolines; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Theobromine; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 28, 2013
• First Posted: July 9, 2013
• Study Start: June 1, 2008
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: July 9, 2013

Record last verified: 2013-07

Locations

ME (1)