Anaemetro I.V. Infusion 500mg Drug Use Investigation
METRONIDAZOLE IV DRUG USE INVESTIGATION
1 other identifier
observational
107
0 countries
N/A
Brief Summary
Secondary Data Collection Study; safety and effectiveness of Anaemetro under Japanese medical practice
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2015
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedFirst Submitted
Initial submission to the registry
March 27, 2018
CompletedFirst Posted
Study publicly available on registry
April 9, 2018
CompletedResults Posted
Study results publicly available
December 28, 2018
CompletedDecember 28, 2018
December 1, 2018
2.1 years
March 27, 2018
July 23, 2018
December 26, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants With Adverse Drug Reaction (ADR)
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.
Maximum 8 weeks
Secondary Outcomes (2)
Clinical Response Rate
Maximum 8 weeks
Clinical Response Rates by Target Diseases
Maximum 8 weeks
Eligibility Criteria
Patients who satisfy all of the inclusion criteria are subject to this study.
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2018
First Posted
April 9, 2018
Study Start
July 1, 2015
Primary Completion
August 1, 2017
Study Completion
August 1, 2017
Last Updated
December 28, 2018
Results First Posted
December 28, 2018
Record last verified: 2018-12
Data Sharing
- IPD Sharing
- Will not share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.