Bromocriptine and Pentoxifylline in Ophthalmopathy Autoimmune Treatment

NCT ID: NCT01893450

Last Updated: 2013-07-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2013-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

methimazole

methimazole 30 mg daily during one year

Group Type: ACTIVE_COMPARATOR

Methimazole

Intervention Type: DRUG

methimazole, bromocriptine

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

Group Type: ACTIVE_COMPARATOR

Bromocriptine

Intervention Type: DRUG

pentoxifylline

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

Group Type: ACTIVE_COMPARATOR

Pentoxifylline

Intervention Type: DRUG

Interventions

Methimazole

Intervention Type: DRUG

Bromocriptine

Intervention Type: DRUG

Pentoxifylline

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

OTHER

Sponsor Role: lead

Responsible Party

Paloma Almeda-Valdés

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Mexico City, Mexico City, Mexico

Countries

Mexico

Other Identifiers

DIA19508091

Identifier Type: -

Identifier Source: org_study_id