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Bromocriptine and Pentoxifylline in Ophthalmopathy Autoimmune Treatment

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ClinicalTrials.gov Identifier: NCT01893450
Recruitment Status : Terminated (Efficacy demonstrated on a preliminary analysis)
First Posted : July 9, 2013
Last Update Posted : July 9, 2013
Sponsor:
Information provided by (Responsible Party):
Paloma Almeda-Valdés, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

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.


Condition or disease Intervention/treatment Phase
Graves Ophthalmopathy Drug: Methimazole Drug: Bromocriptine Drug: Pentoxifylline Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: 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 Start Date : June 2008
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

Arm Intervention/treatment
Active Comparator: methimazole
methimazole 30 mg daily during one year
Drug: Methimazole
Active Comparator: methimazole, bromocriptine
methimazole 30 mg daily during one year, bromocriptine 5 mg twice a day during one year
Drug: Bromocriptine
Active Comparator: pentoxifylline
methimazol 30 mg daily and pentoxifylline 400 mg twice a day during one year
Drug: Pentoxifylline



Primary Outcome Measures :
  1. Proptosis [ Time Frame: One year ]
    Left and right eye proptosis by exophthalmometry


Secondary Outcome Measures :
  1. Clinical activity score [ Time Frame: One year ]
    Clinical activity score for Graves' ophthalmopathy

  2. Quality of life [ Time Frame: One year ]
    Quality of life assessed with the quality of life questionnaire specific for Graves' ophthalmopathy (GO-QOL)



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01893450


Locations
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Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, Distrito Federal, Mexico, 14000
Sponsors and Collaborators
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

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Responsible Party: Paloma Almeda-Valdés, MD, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
ClinicalTrials.gov Identifier: NCT01893450     History of Changes
Other Study ID Numbers: DIA19508091
First Posted: July 9, 2013    Key Record Dates
Last Update Posted: July 9, 2013
Last Verified: July 2013
Keywords provided by Paloma Almeda-Valdés, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran:
Graves ophthalmopathy
Exophthalmos
Proptosis
Quality of life
Additional relevant MeSH terms:
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Graves Ophthalmopathy
Eye Diseases
Eye Diseases, Hereditary
Graves Disease
Exophthalmos
Orbital Diseases
Genetic Diseases, Inborn
Goiter
Thyroid Diseases
Endocrine System Diseases
Hyperthyroidism
Autoimmune Diseases
Immune System Diseases
Pentoxifylline
Bromocriptine
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Vasodilator Agents
Free Radical Scavengers
Antioxidants
Antiparkinson Agents
Anti-Dyskinesia Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Dopamine Agonists