Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 10 of 25 for:    "Hyperthyroidism" | "Protective Agents"

99Tc-MDP for Thyroid-Associated Ophthalmopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03948191
Recruitment Status : Completed
First Posted : May 13, 2019
Last Update Posted : May 15, 2019
Sponsor:
Information provided by (Responsible Party):
Dalian University

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.

Condition or disease Intervention/treatment Phase
Thyroid-Associated Ophthalmopathy Drug: Methylprednisolone Drug: 99Tc-MDP(99Technetium-Methylenediphosphonate Injection) Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-masked, Methylprednisolone-control, Efficacy and Safety Study of 99Tc-MDP for Thyroid Associated Ophthalmopathy.
Actual Study Start Date : October 16, 2017
Actual Primary Completion Date : December 30, 2018
Actual Study Completion Date : March 31, 2019


Arm Intervention/treatment
Active Comparator: 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.
Drug: Methylprednisolone
500mg i.v. infusion once a week for 6 weeks followed by 250mg i.v. once a week for 6 weeks.

Experimental: 99Tc-MDP
99Tc-MDP 15mg i.v. infusion once a day for 10 days, 20 days apart, received 3 courses of infusions.
Drug: 99Tc-MDP(99Technetium-Methylenediphosphonate Injection)
15mg i.v. infusion once a day for 10 days, 20 days apart, received 3 courses of infusions.
Other Name: Yunke




Primary Outcome Measures :
  1. Responder Status at Week 12 [ Time Frame: Week 12 ]
    This end point main evaluation improvement of clinical activity score and proptosis at week 12. A reduction of the CAS 2 point or more, and reduction of the proptosis 2 mm or more was defined as response.


Secondary Outcome Measures :
  1. Overall Average Continuous Change in CAS From Baseline to Week 24 [ Time Frame: Baseline to Week 24 ]
    The 7-item European Group on Graves' Ophthalmopathy (EUGOGO) amended CAS was used to evaluate clinical activity. CAS of 3 point or more on a 7-point scale indicating active thyroid-associated ophthalmopathy.

  2. Overall Average Continuous Change in Proptosis From Baseline to Week 24 [ Time Frame: Baseline to Week 24 ]
    Proptosis is the amount of protrusion of the eye from the orbital rim. Measurements were recorded with the Hertel exophthalmometer.

  3. Overall Average Change in Diplopia grading From Baseline to Week 24 [ Time Frame: Baseline to Week 24 ]

    Diplopia grading included 01/4no:no diplopia; 11/4intermittent: diplopia in primary position of gaze, when tired or when first awakening; 21/4inconstant: diplopia at extremes of gaze; 31/4constant: continuous diplopia in primary or reading position).

    Diplopia change in one grade or more at week 24 was regarded as improvement.


  4. Overall Average Change in extra-ocular muscular thickening From Baseline in thickening extra-ocular muscular improvement in Orbital CT to Week 24 [ Time Frame: Baseline to Week 24 ]
    Observation of extra-ocular muscular thickening is observed on Orbital CT. One or more extra-ocular muscle recovery at week 24 was regarded as improvemed.

  5. Overall Average Change in Graves' Ophthalmopathy Quality of Life (GO-QOL) Scale From baseline to Week 24 follow-up [ Time Frame: Baseline to Week 24 ]
    The GO-QOL is a 16-item self-administered questionnaire used to assess the perceived effects of thyroid associated ophthalmopathy (TAO) by the participants on their daily physical and psychosocial functioning. Two subscales of the 16-question GO-QOL have been defined: Visual Functioning and Appearance, with 8 questions comprising each subscale.The transformed overall score is the sum of scores from all 16 questions to a scale of 0 (worst health) to 100 (best health). A change of 8 point was defined as improvement.

  6. Overall Average Change in GO-QOLScale - Visual Functioning From baseline to Week 24 follow-up [ Time Frame: Baseline to Week 24 ]
    Transformed Visual Functioning score is the sum of scores from following 8 questions to a scale of 0 (worst health) to 50 (best health): bicycling, driving, moving around the house, walking outdoors, reading, watching television (TV), hobby or pastime, feel hindered.

  7. Overall Average Change in GO-QOLScale - Appearance From baseline to Week 24 follow-up [ Time Frame: Baseline to Week 24 ]
    Transformed Appearance score is the sum of scores from the following 8 questions to a scale of 0 (worst health) to 50 (best health): feel appearance has changed, feel being stared at, feel people react unpleasantly, influence on self-confidence, feel socially isolated, influence on making friends, appear less often on photos, try to mask changes in appearance.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 76 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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): NCT03948191


Locations
Layout table for location information
China, Liaoning
Affiliated Zhongshan Hospital of Dalian University
Dalian, Liaoning, China, 116001
Sponsors and Collaborators
Dalian University

Layout table for additonal information
Responsible Party: Dalian University
ClinicalTrials.gov Identifier: NCT03948191     History of Changes
Other Study ID Numbers: zsyy_nfm2-2017-10
First Posted: May 13, 2019    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Dalian University:
99Tc-MDP
TAO
efficacy
safety
Additional relevant MeSH terms:
Layout table for MeSH terms
Hyperthyroidism
Protective Agents
Graves Ophthalmopathy
Thyroid Diseases
Eye Diseases
Endocrine System Diseases
Eye Diseases, Hereditary
Graves Disease
Exophthalmos
Orbital Diseases
Genetic Diseases, Inborn
Goiter
Autoimmune Diseases
Immune System Diseases
Methylene diphosphonate
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Technetium Tc 99m Medronate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids