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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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30 March 2015 |
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Main ID: |
NCT01472263 |
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Date of registration:
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11/11/2011 |
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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 Pentoxifylline in Human T-lymphotropic Virus Type-1 (HTLV-1) Diseases
Pentox |
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Scientific title:
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Effectiveness of Pentoxifylline in Attenuating Neurological Disease Associated With HTLV-1 and Negative Modulator of Pathological Immune Response. |
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Date of first enrolment:
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September 2009 |
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Target sample size:
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48 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01472263 |
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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: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Davi Costa, 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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Federal University of Bahia |
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Name:
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Edgar M Carvalho, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Federal University of Bahia |
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Name:
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André Muniz Santos, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Federal University of Bahia |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age = 18 and = 80 years;
- Confirmed HTLV-1 infection with Western Blot analysis;
- HAM/TSP diagnosed patients according to the WHO
- Patients with HTLV-1 and neurogenic bladder diagnosed by clinical and urodynamic
study
- Disease duration < 5 years
Exclusion Criteria:
- Neurological diseases with functional limitations.
- Co-infection with Hepatitis B or C, Syphilis, Chagas Disease or HIV
- Use of immunossupressive drugs
- Immune disease
- Pregnancy
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Immune System Diseases
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Pentoxifylline
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Physical Disability
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HTLV-1
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Tropical Spastic Paraparesis
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Intervention(s)
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Drug: Pentoxifylline
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Drug: Placebo
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Primary Outcome(s)
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Functional neurological capacity
[Time Frame: 60 days]
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Secondary Outcome(s)
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Reduce in cytokines and chemokines
[Time Frame: 60 days]
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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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