A Stratified Sickle Event Randomized Trial (ASSERT)

NCT ID: NCT00102791

Last Updated: 2008-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

297 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2007-06-30

Brief Summary

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The purpose of this study is to compare the effects of ICA-17043 to placebo with or without hydroxyurea (an oral drug used for treatment of sickle cell disease) in patients with sickle cell disease who have had 2 or more acute sickle-related painful crises requiring a visit to a medical facility within the past 12 months.

Detailed Description

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Conditions

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Sickle Cell Disease

Keywords

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Sickle Cell Anemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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ICA-17043

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 16 to 65 years of age (inclusive)
* Male or female (not capable of becoming pregnant or using appropriate birth control)
* Medical history of sickle cell disease
* Have a history of at least two or more acute sickle-related painful crises requiring a visit to a medical facility within the preceding 12 months

Exclusion Criteria

* Hemoglobin \<4 or \>11 g/dL
* On a chronic transfusion program
* Has significant active and poorly controlled (unstable) cardiovascular, neurologic, endocrine, hepatic, or renal disorders clearly unrelated to sickle cell disease
Minimum Eligible Age

16 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

INDUSTRY

Sponsor Role collaborator

Icagen

INDUSTRY

Sponsor Role lead

Principal Investigators

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Jonathan W Stocker, Ph.D.

Role: STUDY_DIRECTOR

Icagen

Locations

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Mobile, Alabama, United States

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Little Rock, Arkansas, United States

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Davis, California, United States

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Los Angeles, California, United States

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Oakland, California, United States

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Denver, Colorado, United States

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Hartford, Connecticut, United States

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Washington D.C., District of Columbia, United States

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Holly Hill, Florida, United States

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Hollywood, Florida, United States

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Jacksonville, Florida, United States

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Augusta, Georgia, United States

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Savannah, Georgia, United States

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Chicago, Illinois, United States

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Iowa City, Iowa, United States

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New Orleans, Louisiana, United States

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Shreveport, Louisiana, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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Detroit, Michigan, United States

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Jackson, Mississippi, United States

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Kansas City, Missouri, United States

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Las Vegas, Nevada, United States

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Hackensack, New Jersey, United States

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New Brunswick, New Jersey, United States

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Newark, New Jersey, United States

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Brooklyn, New York, United States

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The Bronx, New York, United States

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Chapel Hill, North Carolina, United States

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Durham, North Carolina, United States

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Greenville, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Charleston, South Carolina, United States

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Memphis, Tennessee, United States

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Nashville, Tennessee, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Richmond, Virginia, United States

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Porto Alegre, , Brazil

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Rio de Janeiro, , Brazil

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São Paulo, , Brazil

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Créteil, , France

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Kingston, , Jamaica

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Port of Spain, , Trinidad and Tobago

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London, , United Kingdom

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Countries

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United States Brazil France Jamaica Trinidad and Tobago United Kingdom

References

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Stocker JW, De Franceschi L, McNaughton-Smith GA, Corrocher R, Beuzard Y, Brugnara C. ICA-17043, a novel Gardos channel blocker, prevents sickled red blood cell dehydration in vitro and in vivo in SAD mice. Blood. 2003 Mar 15;101(6):2412-8. doi: 10.1182/blood-2002-05-1433. Epub 2002 Nov 14.

Reference Type BACKGROUND
PMID: 12433690 (View on PubMed)

Related Links

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Other Identifiers

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ICA-17043-10

Identifier Type: -

Identifier Source: org_study_id