Graves OphthalmopathyNCT01893450
Bromocriptine and Pentoxifylline in Ophthalmopathy Autoimmune Treatment
A study testing Methimazole, Bromocriptine and Pentoxifylline in people with Graves Ophthalmopathy, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Graves Ophthalmopathy
- What is being tested?
- Methimazole, Bromocriptine and Pentoxifylline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteMexico
- Study dates
- Jun 2008to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Women or men
- Between 18 and 45 years
- Autoimmune hyperthyroidism with one year or less of evolution
- No previous treatment
- Mild to moderate ophthalmopathy
Who cannot join
- Smoking
- Severe ophthalmopathy
- Steroid treatment
- Asthma
- Diabetes or other significant disease
- Creatine >1.5 mg/dl
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, Mexico City, 14000
About this study
Official title: Comparison of the Effect of Bromocriptine and Pentoxifylline in Mild to Moderate Autoimmune Ophthalmopathy. A Randomized, Controlled, Single Blind, Clinical Trial.
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
- Being tested
- Methimazole, Bromocriptine, Pentoxifylline
- Keywords
- Graves ophthalmopathy, Exophthalmos, Proptosis, Quality of life
- Medical subject headings
- Graves Ophthalmopathy, Exophthalmos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethimazoleDrug
BromocriptineDrug
PentoxifyllineDrug
| Study group | Role | What they receive |
|---|---|---|
| methimazole | Active comparator | methimazole 30 mg daily during one year Receives: Drug: Methimazole |
| methimazole, bromocriptine | Active comparator | methimazole 30 mg daily during one year, bromocriptine 5 mg twice a day during one year Receives: Drug: Bromocriptine |
| pentoxifylline | Active comparator | methimazol 30 mg daily and pentoxifylline 400 mg twice a day during one year Receives: Drug: Pentoxifylline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proptosis
Left and right eye proptosis by exophthalmometry
Measured: One year
Secondary outcomes (2)
Clinical activity score
Clinical activity score for Graves' ophthalmopathy
Measured: One year
Quality of life
Quality of life assessed with the quality of life questionnaire specific for Graves' ophthalmopathy (GO-QOL)
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2013 (estimated)
- Study startJun 2008
- Primary completionJun 2013
- Study completionJun 2013
Why it stopped: Efficacy demonstrated on a preliminary analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graves OphthalmopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paloma Almeda-Valdés, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01893450
- Sponsor's protocol ID
- DIA19508091
- Status last verified
- Jul 2013
- First submitted
- 28 Jun 2013
- Last updated
- 9 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of Bromocriptine and Pentoxifylline in Mild to Moderate Autoimmune Ophthalmopathy. A Randomized, Controlled, Single Blind, Clinical Trial.
- ClinicalTrials.gov ID
- NCT01893450
- Acronym / sponsor ID
- DIA19508091
- Conditions
- Graves Ophthalmopathy
- Keywords
- Graves ophthalmopathy, Exophthalmos, Proptosis, Quality of life
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Efficacy demonstrated on a preliminary analysis
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 9 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| methimazole | Active comparator | Drug: Methimazolemethimazole 30 mg daily during one year |
| methimazole, bromocriptine | Active comparator | Drug: Bromocriptinemethimazole 30 mg daily during one year, bromocriptine 5 mg twice a day during one year |
| pentoxifylline | Active comparator | Drug: Pentoxifyllinemethimazol 30 mg daily and pentoxifylline 400 mg twice a day during one year |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women or men
- Between 18 and 45 years
- Autoimmune hyperthyroidism with one year or less of evolution
- No previous treatment
- Mild to moderate ophthalmopathy
Key exclusion criteria (12 listed)
- Smoking
- Severe ophthalmopathy
- Steroid treatment
- Asthma
- Diabetes or other significant disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methimazole | Drug | methimazole |
| Bromocriptine | Drug | methimazole, bromocriptine |
| Pentoxifylline | Drug | pentoxifylline |
Primary outcome
Proptosis
Time frame: One year
Left and right eye proptosis by exophthalmometry
2 secondary outcomes
Clinical activity score
Time frame: One year
Quality of life
Time frame: One year
Results and safety
The study was stopped early (reason given: Efficacy demonstrated on a preliminary analysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Methimazole, Bromocriptine and Pentoxifylline in people with Graves Ophthalmopathy, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Efficacy demonstrated on a preliminary analysis). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proptosis (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2013.