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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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16 December 2017 |
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Main ID: |
NCT02464124 |
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Date of registration:
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03/06/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Nitazoxanide Plus Lactulose Versus Lactulose Alone Treatment of Hepatic Encephalopathy
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Scientific title:
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A Randomized, Double-blind, Controlled Trial Comparing Nitazoxanide Plus Lactulose With Lactulose Alone Treatment of Overt Hepatic Encephalopathy |
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Date of first enrolment:
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January 2016 |
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Target sample size:
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120 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02464124 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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Egypt
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Contacts
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Name:
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Sherief Abd-elsalam, lecturer |
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Address:
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Telephone:
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00201095159522 |
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Email:
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Sheriefabdelsalam@yahoo.com |
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Affiliation:
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Name:
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Rehab elsheshtawi, lecturer |
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Address:
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Telephone:
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Email:
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Affiliation:
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hepatology dept-Tanta |
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Name:
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Samah Soliman, lecturer |
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Address:
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Telephone:
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Email:
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Affiliation:
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hepatology dept-Tanta |
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Name:
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Asem Elfert, Prof |
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Address:
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Telephone:
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Email:
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Affiliation:
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hepatology dept-Tanta |
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Name:
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Sherief Abdelsalam, lecturer |
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Address:
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Telephone:
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00201095159522 |
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Email:
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Sheriefabdelsalam@yahoo.com |
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Affiliation:
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Name:
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Mennat-Allah Elsawaf, lecturer |
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Address:
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Telephone:
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Email:
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Affiliation:
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hepatology dept-Tanta |
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Name:
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Sherief Abd-Elsalam, lecturer |
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Address:
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Telephone:
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Email:
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Affiliation:
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hepatology dept-Tanta |
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Name:
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Walaa elkhalawany, lecturer |
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Address:
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Telephone:
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Email:
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Affiliation:
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hepatology dept-Tanta |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
Age 18-70 years
Cirrhosis, defined by a combination of any of the following:
- Laboratory findings
- Endoscopic results
- Ultrasound
- Histology Overt hepatic encephalopathy
Exclusion Criteria:
- • Creatinine>1.5 mg/dl
- Alcohol use within prior 4 weeks
- Non-hepatic metabolic encephalopathy
- Hepatocellular carcinoma
- Degenerative CNS disease
- Any significant psychiatric illness or other medical comorbidity
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Encephalopathy, Hepatic
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Intervention(s)
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Drug: Lactulose
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Drug: Nitazoxanide
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Primary Outcome(s)
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Number of patients with total reversal of hepatic encephalopathy
[Time Frame: 6 months]
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Secondary ID(s)
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Hepatic encephalopathy
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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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