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Main
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Note: This record shows only 22 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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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN02536681 |
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Date of registration:
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20/12/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The effect of ondansetron, a 5-Ht3 receptor antagonist, on fatigue severity and functional impairment in Chronic Fatigue Syndrome patients
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Scientific title:
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Date of first enrolment:
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19/06/2002 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN02536681 |
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Study type:
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Interventional |
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Study design:
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Randomised placebo controlled, parallel group, double blinded trial (Treatment)
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Phase:
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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G K H
The |
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Address:
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Department Internal Medicine - 541
Expert Center Chronic Fatigue
University Medical Centre Nijmegen
P.O. Box 9101
6500 HB
Nijmegen
Netherlands |
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Telephone:
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+31 (0)24 361 8819 |
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Email:
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g.the@aig.umcn.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. CDC-diagnosed CFS-patients
2. Male and female patients 18 - 65 years of age
3. High-fatigue severity level
4. Substantial functional impairment
5. Written informed consent
Exclusion criteria: 1. Pregnancy
2. Lactating women
3. Participation in CFS-treatment programs
4. Participation in other CFS-research
5. Psychopharmaca
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Chronic fatigue syndrome
Nervous System Diseases
Chronic fatigue syndrome
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Intervention(s)
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10 weeks ondansetron versus placebo.
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Primary Outcome(s)
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1. Fatigue severity: measured with Checklist Individual Strength
2. Functional impairment: measured with Sickness Impact Profile
3. CDC-symptoms
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Secondary Outcome(s)
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Physical activity level: measured with actometer
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Source(s) of Monetary Support
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GlaxoSmithKline (Netherlands)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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