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Sugammadex Hypersensitivity Study (Study P06042)(COMPLETED)

2014-08-27 03:18:57 | BioPortfolio

Summary

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.

Description

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.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Hypersensitivity

Intervention

Sugammadex 4 mg/kg, Sugammadex 16 mg/kg, Placebo

Status

Completed

Source

Schering-Plough

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:18:57-0400

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Medical and Biotech [MESH] Definitions

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Antigen-type substances that produce immediate hypersensitivity (HYPERSENSITIVITY, IMMEDIATE).

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