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. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 February 2015 |
Main ID: |
NCT00361387 |
Date of registration:
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07/08/2006 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Use of Focalin for Fatigue in Sarcoidosis
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Scientific title:
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Randomized, Double-Blind, Placebo-Controlled Study of Dexmethylphenidate Hydrochloride, (d-MPH) in the Treatment of Fatigue in Sarcoidosis Subjects. |
Date of first enrolment:
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June 2006 |
Target sample size:
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12 |
Recruitment status: |
Completed |
URL:
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http://clinicaltrials.gov/show/NCT00361387 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized, Endpoint Classification: 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 4
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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 |
Address:
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Telephone:
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Email:
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Affiliation:
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Unversity of Cincinnati |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosis of sarcoidosis using standard criteria
- Disease for more than one year
- Complain of fatigue which has been present for more than six months.
- Over 18 years of age
Exclusion Criteria:
- Pregnancy
- Change in therapy for sarcoidosis in prior three months
- history of ventricular arrythmias
- Patients with a history of anxiety disorder, glaucoma, motor ties or a family
history of Tourette's syndrome.
- Patients who are currently receiving or have received monoamine oxidase inhibitors
within 14 days prior to study entry.
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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Sarcoidosis
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Intervention(s)
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Drug: d-methylphenidate
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Primary Outcome(s)
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Improvement of fatigue.
[Time Frame: 30 weeks]
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Secondary Outcome(s)
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Improvement of pulmonary status
[Time Frame: 30 weeks]
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Safety of treatment
[Time Frame: 30 weeks]
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Secondary ID(s)
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06-02-23-03
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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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