Ameparomo Capsules 250 mg Drug Use Investigation

Completed

• Conditions: Intestinal Amebiasis

• Registration Number: NCT02680665
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-19
• Study First Submitted: 2016-02-09
• Study First Submitted QC: 2016-02-09
• Study First Posted: 2016-02-11
• Primary Completion: 2018-12-21
• Study Completion: 2018-12-21
• Results First Submitted: 2019-12-11
• Results First Submitted QC: 2019-12-11
• Results First Posted: 2020-01-02
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-07
• Last Update Posted: 2020-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Patients with no history of using this product

Exclusion Criteria

• No exclusion criteria are set out in this study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Drug Reactions	38 days at maximum	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.

Secondary Outcome Measures

Name	Time	Method
Proportion of Cyst Negative	10 days + 3 months at maximum	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".
Overall Clinical Response Rate	10 days at maximum	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.