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This trial is being conducted to study the potential for hypersensitivity symptoms at the time of initial exposure to sugammadex and upon repeat exposure, since it is unknown whether the frequency or severity of hypersensitivity symptoms may worsen at repeat exposure over a prolonged period.
Participants will be randomized to receive one of three study treatments: sugammadex 4 mg/kg, sugammadex 16 mg/kg, or placebo. Participants will receive one dose of study treatment on Day 8, Day 36, and Day 78 of the study in order to determine the safety of each treatment dose.
To ensure safety of the participants, all participants will be admitted to the study center the day before each scheduled dose and will leave the unit the morning of the day after each dose. In cases of suspected hypersensitivity symptoms, participants will remain confined to the study center until all signs and symptoms regress, the participant is stable and the investigator considers it safe for the participant to leave the study center.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Sugammadex 4 mg/kg, Sugammadex 16 mg/kg, Placebo
Published on BioPortfolio: 2014-08-27T03:18:57-0400
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Allergic reaction to products containing processed natural rubber latex such as rubber gloves, condoms, catheters, dental dams, balloons, and sporting equipment. Both T-cell mediated (HYPERSENSITIVITY, DELAYED) and IgE antibody-mediated (HYPERSENSITIVITY, IMMEDIATE) allergic responses are possible. Delayed hypersensitivity results from exposure to antioxidants present in the rubber; immediate hypersensitivity results from exposure to a latex protein.
Antigen-type substances that produce immediate hypersensitivity (HYPERSENSITIVITY, IMMEDIATE).
Epicutaneous or intradermal application of a sensitizer for demonstration of either delayed or immediate hypersensitivity. Used in diagnosis of hypersensitivity or as a test for cellular immunity.
Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.
A form of hypersensitivity affecting the respiratory tract. It includes ASTHMA and RHINITIS, ALLERGIC, SEASONAL.
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