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NCT02680665 Clinical Trial

Ameparomo Capsules 250 mg Drug Use Investigation

Intestinal Amebiasis Clinical Trial

Official title:
AMEPAROMO CAPSULES 250 MG DRUG USE INVESTIGATION

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02680665
Other study ID # B3391001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 19, 2015
Est. completion date December 21, 2018

Study information
Verified date December 2020
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This Study is intended to evaluate the safety and effectiveness of Ameparomo Capsules 250 mg under actual medical practice.

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date December 21, 2018
Est. primary completion date December 21, 2018
Accepts healthy volunteers No
Gender All
Age group 15 Years to 99 Years
Eligibility Inclusion Criteria: - Patients with no history of using this product Exclusion Criteria: - No exclusion criteria are set out in this study.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Participants With Adverse Drug Reactions An adverse drug reaction (ADR) was any untoward medical occurrence attributed to AMEPAROMO capsules in a participant who received AMEPAROMO capsules. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to AMEPAROMO capsules was assessed by the physician. 38 days at maximum
Secondary Proportion of Cyst Negative Proportion of cyst negative, which was defined as the percentage of participants with negative results in the examination of cysts after AMEPAROMO capsules up to 3 months after the completion of observation period or discontinuation of treatment, was presented along with its 2-sided 95% CI. The results of the examination of cysts were assessed as "negative ", "positive", or "indeterminate". 10 days + 3 months at maximum
Secondary Overall Clinical Response Rate Clinical response rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented along with its 2-sided 95% CI. Clinical response of AMEPAROMO capsules was assessed as "effective", "not effective", or "indeterminate" by the physician based on the clinical course at the end of the observation period or at the time of treatment discontinuation. 10 days at maximum

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