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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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19 February 2015 |
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Main ID: |
NCT02328144 |
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Date of registration:
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22/12/2014 |
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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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Effectiveness of Metronidazole in Pain Control Posthemorrhoidectomy
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Scientific title:
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Effectiveness of Metronidazole Versus Homologated Placebo in Pain Control Posthemorrhoidectomy |
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Date of first enrolment:
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July 2013 |
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Target sample size:
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44 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT02328144 |
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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: Parallel Assignment, Masking: Double Blind (Subject, Investigator), 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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Mexico
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Contacts
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Name:
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Clotilde Fuentes-Orozco, 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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Instituto Mexicano del Seguro Social |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Hemorrhoidal disease grade III and IV
- Informed consent
Exclusion Criteria:
- Pregnancy
- Lactation
- Other anorectal disease
- Previous anorectal
- hypersensibility to metronidazole
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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Hemorrhoids
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Intervention(s)
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Drug: Metronidazole
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Drug: Placebo
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Primary Outcome(s)
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Pain evolution, hours and days after surgery
[Time Frame: 6 and 12 hours, 1, 4, 7 and 14 days]
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Secondary Outcome(s)
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Interleukin
[Time Frame: after surgery and 12 hours]
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Return to normal activities
[Time Frame: 1, 4, 7 and 14 days]
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Analgesics
[Time Frame: 6 and 12 hours, 1, 4, 7 and 14 days]
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Satisfaction
[Time Frame: 14 day]
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Surgery complications
[Time Frame: 6 and 12 hours, 1, 4, 7 and 14 days]
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Secondary ID(s)
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R-2013-1301-71
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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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