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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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7 January 2013 |
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Main ID: |
NCT01393847 |
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Date of registration:
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12/07/2011 |
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Primary sponsor: |
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Public title:
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Nitric Oxide and Sickle Cell Pain
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Scientific title:
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Biochemical and Genetic Mechanisms for Etiology of Sickle Cell Pain |
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Date of first enrolment:
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June 2011 |
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Target sample size:
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90 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01393847 |
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Study type:
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Observational |
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Study design:
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Time Perspective: Prospective
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Countries of recruitment
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United States
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Contacts
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Name:
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For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL) |
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Address:
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Telephone:
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800-411-1222 |
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Email:
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prpl@mail.cc.nih.gov |
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Affiliation:
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Name:
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Wendy B Smith, Ph.D. |
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Address:
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Telephone:
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(301) 451-0089 |
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Email:
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smithwe@mail.nih.gov |
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Affiliation:
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Name:
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Alan N Schechter, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
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Key inclusion & exclusion criteria
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- INCLUSION CRITERIA FOR SICKLE CELL SUBJECTS:
All subjects with sickle cell disease will be eligible for enrollment in this study if
they meet all of the following criteria:
18 years of age or older
Diagnosis of sickle cell disease (electrophoretic or HPLC documentation of hemoglobin S
only phenotype is required)
No vaso-occlusive crisis during the previous two weeks
Medically stable
Can speak and understand English to complete assessments and scales
INCLUSION CRITERIA FOR MATCHED CONTROLS:
All volunteer matched control study participants will be eligible for enrollment on this
study if they meet all the following criteria:
18 years of age or older
Non-sickle cell trait or disease
Medically healthy based upon the history and physical exam and screening blood analyses
No chronic pain condition.
Can speak and understand English to complete assessments and scales
Ethnicity, age (within 5 years), and sex matched to that of sickle cell subjects already
enrolled on study
EXCLUSION CRITERIA FOR ALL STUDY PARTICIPANTS:
Study participants will be excluded from the study if he/she has one or more of the
following:
Inability to provide his/her own informed consent.
Drug or alcohol dependence/abuse within the past 5 years
Cigarette smoking or the use of any tobacco products within two years
Use of tranquilizers, steroids, non-steroidal anti-inflammatory agents three or more times
per week.
Clinically significant medical condition that will confound the analysis of factors
associated with sickle cell pain, such as:
- Chronic inflammatory disease (i.e. rheumatoid arthritis, systemic lupus
erythematosus, cirrhosis)
- Diabetes mellitus
- Uncontrolled hypertension
- Known malignancies
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Pain
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Sickle Cell Disease
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Secondary ID(s)
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11-NR-0189
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110189
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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