99Tc-MDP for Thyroid-Associated Ophthalmopathy

NCT ID: NCT03948191

Last Updated: 2019-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-16
• Study Completion Date: 2019-03-31

Brief Summary

To investigate the efficacy，safety and tolerability of 99Tc-MDP in comparison to Methylprednisolone, in the treatment of participants suffering from active moderate to severe TAO.

Conditions

Thyroid-Associated Ophthalmopathy

Study Design

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

Study Groups

Methylprednisolone(ivMP)

Methylprednisolone(ivMP) 500mg i.v. infusion once a week for 6 weeks followed by 250mg i.v. once a week for 6 weeks.

Group Type: ACTIVE_COMPARATOR

Methylprednisolone

Intervention Type: DRUG

500mg i.v. infusion once a week for 6 weeks followed by 250mg i.v. once a week for 6 weeks.

99Tc-MDP

99Tc-MDP 15mg i.v. infusion once a day for 10 days, 20 days apart, received 3 courses of infusions.

Group Type: EXPERIMENTAL

99Tc-MDP(99Technetium-Methylenediphosphonate Injection)

Intervention Type: DRUG

15mg i.v. infusion once a day for 10 days, 20 days apart, received 3 courses of infusions.

Interventions

Methylprednisolone

500mg i.v. infusion once a week for 6 weeks followed by 250mg i.v. once a week for 6 weeks.

Intervention Type: DRUG

99Tc-MDP(99Technetium-Methylenediphosphonate Injection)

15mg i.v. infusion once a day for 10 days, 20 days apart, received 3 courses of infusions.

Intervention Type: DRUG

Other Intervention Names

Yunke

Eligibility Criteria

Inclusion Criteria

• The patient age 18 Years to 76 Years;
• Fewer than 6 months from onset of TAO;
• Clinical diagnosis of Graves' disease associated with active TAO and a clinical activity score of ≥ 3;
• Moderate to severe TAO;
• No previous medical or surgical treatment, excluding local supportive measures and oral steroids if the maximum cumulative dose is less than 1000 mg methylprednisolone or equivalent with at least 6 weeks between last administration of oral steroids and randomization.

Exclusion Criteria

• Optic neuropathy, severe orbital appearance and surgical;
• Extra-thyroid disease;
• Pregnant and children;
• Severe impairment of cardiac, hepatic and renal functions;
• Allergies;
• Other contraindications.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 76 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dalian University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Affiliated Zhongshan Hospital of Dalian University

Dalian, Liaoning, China

Countries

China

Other Identifiers

zsyy_nfm2-2017-10

Identifier Type: -

Identifier Source: org_study_id