NCT01893450

Comparison of the Effect of Bromocriptine and Pentoxifylline in Mild to Moderate Autoimmune Ophthalmopathy. A Randomized, Controlled, Single Blind, Clinical Trial.

Terminated NA Last updated 2 July 2013

What this trial tests

NA trial testing Methimazole in Graves Ophthalmopathy in 31 participants. Terminated before completion.

Timeline

1 June 2008

Primary endpoint
1 June 2013

1 June 2013

Quick facts

Lead sponsor	Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	31
Start date	1 June 2008
Primary completion	1 June 2013
Estimated completion	1 June 2013
Sites	1 location across Mexico

Drugs / interventions tested

• Methimazole — full drug profile →
• Bromocriptine (BROMOCRIPTINE) — full drug profile →
• Pentoxifylline — full drug profile →

Conditions studied

• Graves Ophthalmopathy — all drugs for Graves Ophthalmopathy →

Sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran — full company profile →

Who can join

Adults 18 to 45, any sex, with Graves Ophthalmopathy. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Proptosis
  Time frame: One year
  Left and right eye proptosis by exophthalmometry

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.