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OpenTrials
Completed

NCT Number: NCT02680665

Ameparomo Capsules 250 mg Drug Use Investigation

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

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Key information

Conditions

Intestinal Amebiasis Amebiasis Digestive System Diseases Dysentery Dysentery, Amebic Gastroenteritis Gastrointestinal Diseases Infections Intestinal Diseases Intestinal Diseases, Parasitic Parasitic Diseases Protozoan Infections

Age range

15 year–99 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with no history of using this product

Exclusion criteria

  • No exclusion criteria are set out in this study.

Treatment and study plan

Primary outcomes

  1. Number of Participants With Adverse Drug Reactions

    Time frame: 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 outcomes

  1. Proportion of Cyst Negative

    Time frame: 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".

  2. Overall Clinical Response Rate

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Feb 11, 2016
Registry last updated
Dec 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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