Bromocriptine and Pentoxifylline in Ophthalmopathy Autoimmune Treatment
Primary Purpose
Graves Ophthalmopathy
Status
Terminated
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Methimazole
Bromocriptine
Pentoxifylline
Sponsored by
About this trial
This is an interventional treatment trial for Graves Ophthalmopathy focused on measuring Graves ophthalmopathy, Exophthalmos, Proptosis, Quality of life
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
Sites / Locations
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
methimazole
methimazole, bromocriptine
pentoxifylline
Arm Description
methimazole 30 mg daily during one year
methimazole 30 mg daily during one year, bromocriptine 5 mg twice a day during one year
methimazol 30 mg daily and pentoxifylline 400 mg twice a day during one year
Outcomes
Primary Outcome Measures
Proptosis
Left and right eye proptosis by exophthalmometry
Secondary Outcome Measures
Clinical activity score
Clinical activity score for Graves' ophthalmopathy
Quality of life
Quality of life assessed with the quality of life questionnaire specific for Graves' ophthalmopathy (GO-QOL)
Full Information
NCT ID
NCT01893450
First Posted
June 28, 2013
Last Updated
July 2, 2013
Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
1. Study Identification
Unique Protocol Identification Number
NCT01893450
Brief Title
Bromocriptine and Pentoxifylline in Ophthalmopathy Autoimmune Treatment
Official Title
Comparison of the Effect of Bromocriptine and Pentoxifylline in Mild to Moderate Autoimmune Ophthalmopathy. A Randomized, Controlled, Single Blind, Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Terminated
Why Stopped
Efficacy demonstrated on a preliminary analysis
Study Start Date
June 2008 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Graves Ophthalmopathy
Keywords
Graves ophthalmopathy, Exophthalmos, Proptosis, Quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
methimazole
Arm Type
Active Comparator
Arm Description
methimazole 30 mg daily during one year
Arm Title
methimazole, bromocriptine
Arm Type
Active Comparator
Arm Description
methimazole 30 mg daily during one year, bromocriptine 5 mg twice a day during one year
Arm Title
pentoxifylline
Arm Type
Active Comparator
Arm Description
methimazol 30 mg daily and pentoxifylline 400 mg twice a day during one year
Intervention Type
Drug
Intervention Name(s)
Methimazole
Intervention Type
Drug
Intervention Name(s)
Bromocriptine
Intervention Type
Drug
Intervention Name(s)
Pentoxifylline
Primary Outcome Measure Information:
Title
Proptosis
Description
Left and right eye proptosis by exophthalmometry
Time Frame
One year
Secondary Outcome Measure Information:
Title
Clinical activity score
Description
Clinical activity score for Graves' ophthalmopathy
Time Frame
One year
Title
Quality of life
Description
Quality of life assessed with the quality of life questionnaire specific for Graves' ophthalmopathy (GO-QOL)
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
14000
Country
Mexico
12. IPD Sharing Statement
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Bromocriptine and Pentoxifylline in Ophthalmopathy Autoimmune Treatment
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