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A Study to Investigate the Efficacy and Safety of S-888711 Tablets Administered to Adult Subjects With Immune Thrombocytopenia (ITP)

2014-08-27 03:16:27 | BioPortfolio

Summary

This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-ranging, parallel-group study to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of S-888711 in the treatment of subjects with immune thrombocytopenia. Eligible subjects will be randomized into one of four treatment groups to receive S-888711 0.5 mg, 0.75 mg, or 1.0 mg or placebo.

Study Design

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

Conditions

Immune Thrombocytopenia (ITP)

Intervention

placebo to S-888711, S-888711, S-888711, S-888711

Location

Investigator
Anaheim
California
United States
92801

Status

Recruiting

Source

Shionogi USA, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:27-0400

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Medical and Biotech [MESH] Definitions

An antihelminthic drug that has been tried experimentally in rheumatic disorders where it apparently restores the immune response by increasing macrophage chemotaxis and T-lymphocyte function. Paradoxically, this immune enhancement appears to be beneficial in rheumatoid arthritis where dermatitis, leukopenia, and thrombocytopenia, and nausea and vomiting have been reported as side effects. (From Smith and Reynard, Textbook of Pharmacology, 1991, p435-6)

Thrombocytopenia occurring in the absence of toxic exposure or a disease associated with decreased platelets. It is mediated by immune mechanisms, in most cases IMMUNOGLOBULIN G autoantibodies which attach to platelets and subsequently undergo destruction by macrophages. The disease is seen in acute (affecting children) and chronic (adult) forms.

Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.

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An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.

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