Anaemetro I.V. Infusion 500mg Drug Use Investigation

Completed

• Conditions: Anaerobic Infection; Infectious Enterocolitis; Amebic Dysentery

• Registration Number: NCT03491228
• Lead Sponsor: Pfizer

Brief Summary

Secondary Data Collection Study; safety and effectiveness of Anaemetro under Japanese medical practice

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07
• Primary Completion: 2017-08
• Study Completion: 2017-08
• Study First Submitted: 2018-03-27
• Study First Submitted QC: 2018-04-05
• Study First Posted: 2018-04-09
• Results First Submitted: 2018-07-23
• Status Verified: 2018-12
• Results First Submitted QC: 2018-12-26
• Last Update Submitted: 2018-12-26
• Results First Posted: 2018-12-28
• Last Update Posted: 2018-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

Inclusion Criteria

• Patients who have not used metronidazole (injection) in the past, and have been given this drug for treatment of anaerobic infection, infectious enterocolitis, or amebic dysentery. Patients who have used metronidazole (oral agent and vaginal tablet) in the past are eligible, and should not be excluded from this study.

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Exclusion Criteria

• No exclusion criteria are set out in this study.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Drug Reaction (ADR)	Maximum 8 weeks	An adverse drug reaction (ADR) was any untoward medical occurrence attributed to ANAEMETRO Intravenous infusion in a participant who received ANAEMETRO Intravenous infusion. 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 ANAEMETRO Intravenous infusion was assessed by the physician.

Secondary Outcome Measures

Name	Time	Method
Clinical Response Rate	Maximum 8 weeks	Clinical response of ANAEMETRO Intravenous infusion was evaluated comprehensively at the completion of the observation period, being assessed as "effective," "not effective," or "indeterminate" by the physician based on clinical symptoms.; Clinical response rate, which was defined as the percentage of participants evaluated as "effective" over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI.
Clinical Response Rates by Target Diseases	Maximum 8 weeks	Clinical response of ANAEMETRO Intravenous infusion was evaluated comprehensively at the completion of the observation period, being assessed as "effective," "not effective," or "indeterminate" by the physician based on clinical symptoms.; Clinical response rate, which was defined as the percentage of participants evaluated as "effective" over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI.; Participants assessed as "effective" by the following target diseases were counted to assess whether they contribute to the clinical response: anaerobic infection, infectious enterocolitis, amebic dysentery, and the infection with both infectious enterocolitis and amebic dysentery.