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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12 December 2020 |
Main ID: |
NCT03424733 |
Date of registration:
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31/01/2018 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Evaluating the Use of Prednisone to Decrease Pegylated Interferon Beta-1a Side Effects
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Scientific title:
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A Trial of Prednisone and Acetaminophen Versus Acetaminophen Alone in Minimizing Flu-like Symptoms From Pegylated Interferon Beta-1a |
Date of first enrolment:
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September 25, 2017 |
Target sample size:
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50 |
Recruitment status: |
Recruiting |
URL:
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https://clinicaltrials.gov/show/NCT03424733 |
Study type:
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Interventional |
Study design:
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Allocation: Non-Randomized. Intervention model: Crossover Assignment. Primary purpose: Prevention. Masking: None (Open Label).
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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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Mary Ann Picone, MD |
Address:
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Telephone:
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201-837-0727 |
Email:
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M-picone@mail.holyname.org |
Affiliation:
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Name:
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Mary Ann Picone, MD |
Address:
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Telephone:
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201-837-0727 |
Email:
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m-picone@mail.holyname.org |
Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- diagnosed any form of MS (relapsing remitting, primary progressive, secondary
progressive), any EDSS (expanded stability status scale) score
Exclusion Criteria:
- prior allergic reaction to interferon products, congestive heart failure, elevated
liver enzymes
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Multiple Sclerosis
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Intervention(s)
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Drug: Prednisone
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Drug: Tylenol Pill
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Drug: Plegridy
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Primary Outcome(s)
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Flu-like symptoms
[Time Frame: 12 to 16 weeks]
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Secondary Outcome(s)
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Injection site reactions
[Time Frame: 12 to 16 weeks]
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Secondary ID(s)
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US-PEG-16-10990
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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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