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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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ClinicalTrials.gov |
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Last refreshed on:
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8 June 2015 |
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Main ID: |
NCT00555347 |
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Date of registration:
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07/11/2007 |
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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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Use of Armodafinil for Fatigue in Sarcoidosis
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Scientific title:
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Use of Armodafinil (R-modafinil) for Fatigue in Sarcoidosis |
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Date of first enrolment:
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October 2007 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00555347 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 2/Phase 3
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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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Robert P Baughman, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Cincinnati |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosis of sarcoidosis using standard criteria 15.
- Disease for more than one year
- On stable, systemic therapy
- Complain of fatigue which has been present for more than six months.
- Over 18 years of age
- Provide written informed consent.
Exclusion Criteria:
- Pregnancy
- Change in therapy for sarcoidosis in prior three months
- History of ventricular arrythmias
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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Fatigue
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Sleepiness
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Sarcoidosis
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Intervention(s)
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Drug: Placebo
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Drug: Armodafinil
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Primary Outcome(s)
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To determine the effect of Armodafinil (Nuvigil) on fatigue and sleep in sarcoidosis.
[Time Frame: Prospective]
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Secondary Outcome(s)
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To determine the safety and tolerability of Armodafinil (Nuvigil) in sarcoidosis.
[Time Frame: Prospective]
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To determine the effect of Armodafinil (Nuvigil) on pulmonary function in sarcoidosis.
[Time Frame: Prospective]
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Secondary ID(s)
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IRB 07011901
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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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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