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Sponsored by: |
Genzyme |
Information provided by: | Genzyme |
ClinicalTrials.gov Identifier: | NCT00454220 |
The purpose of this study is to determine the safety and effectiveness of 2 different doses of modified release rhTSH when administered with radioiodine in patients with multinodular goiter, a condition that involves the enlargement of the thyroid gland. We will also evaluate the safety and effectiveness of radioiodine therapy alone in these patients. The goal of the treatment is to determine if there was a reduction in the size of the goiter and to study if goiter symptoms have improved after 6 months.
Condition | Intervention | Phase |
Multinodular Goiter |
Other: Placebo Drug: MRrhTSH |
Phase II |
Drug Information available for: | Thyroid Thyrotropin |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Study to Evaluate the Dose, Safety and Effectiveness of Modified-Release Recombinant Human Thyroid Stimulating Hormone (MRrhTSH) When Used in Conjunction With Radioiodine for the Treatment of Multinodular Goiter. |
Estimated Enrollment: | 99 |
Study Start Date: | April 2007 |
Estimated Study Completion Date: | November 2008 |
Arms | Assigned Interventions |
A: Placebo Comparator
Placebo
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Other: Placebo
placebo + 131-I
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B: Experimental
Dose Group
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Drug: MRrhTSH
0.01 mgMRrhTSH + 131-I
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C: Experimental
Dose Group
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Drug: MRrhTSH
0.03 mg MRrhTSH + 131-I
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Ages Eligible for Study: | 40 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Medical Information | 800-745-4447 | medinfo@genzyme.com |
Contact: Medical Information | 617-252-7832 | medinfo@genzyme.com |
United States, Massachusetts | |||||
Recruiting | |||||
Boston, Massachusetts, United States | |||||
United States, Minnesota | |||||
Not yet recruiting | |||||
Rochester, Minnesota, United States | |||||
United States, Ohio | |||||
Recruiting | |||||
Columbus, Ohio, United States | |||||
Brazil | |||||
Not yet recruiting | |||||
Curitiba, Brazil | |||||
Not yet recruiting | |||||
Sao Paulo, Brazil | |||||
Not yet recruiting | |||||
Rio de Janeiro, Brazil | |||||
Canada, Ontario | |||||
Recruiting | |||||
London, Ontario, Canada | |||||
Denmark | |||||
Recruiting | |||||
Odense, Denmark | |||||
France | |||||
Not yet recruiting | |||||
Lille Cedex, France | |||||
Germany | |||||
Not yet recruiting | |||||
Wurzburg, Germany | |||||
Italy | |||||
Not yet recruiting | |||||
Sienna, Italy | |||||
Not yet recruiting | |||||
Pisa, Italy | |||||
Netherlands | |||||
Recruiting | |||||
Netherlands, Netherlands |
Genzyme |
Study Director: | James Magner, MD | Genzyme |
Responsible Party: | Genzyme ( Medical Monitor ) |
Study ID Numbers: | MRTSH01505 |
First Received: | March 28, 2007 |
Last Updated: | May 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00454220 |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada; European Union: European Medicines Agency; Brazil: National Health Surveillance Agency |
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