Ameparomo Capsules 250 mg Drug Use Investigation

Pfizer120 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

120

Conditions

Intestinal Amebiasis

Eligibility

Sex: ALLMin age: 15 YearsMax age: 99 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with no history of using this product Exclusion Criteria: * No exclusion criteria are set out in this study.

Outcomes

Primary Outcomes

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.

Time frame: 38 days at maximum

Secondary Outcomes

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".

Time frame: 10 days + 3 months at maximum

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.

Time frame: 10 days at maximum

Data from ClinicalTrials.gov

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