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Anaemetro I.V. Infusion 500mg Drug Use Investigation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03491228
Recruitment Status : Completed
First Posted : April 9, 2018
Results First Posted : December 28, 2018
Last Update Posted : December 28, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date March 27, 2018
First Posted Date April 9, 2018
Results First Submitted Date July 23, 2018
Results First Posted Date December 28, 2018
Last Update Posted Date December 28, 2018
Actual Study Start Date July 2015
Actual Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 26, 2018)
Number of Participants With Adverse Drug Reaction (ADR) [ Time Frame: 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.
Original Primary Outcome Measures
 (submitted: April 5, 2018)
Number of Participants with Adverse Events (AEs) by Seriousness and Relationship to Treatment [ Time Frame: Maximum 8 weeks ]
Change History Complete list of historical versions of study NCT03491228 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: December 26, 2018)
  • Clinical Response Rate [ Time Frame: 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 [ Time Frame: 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.
Original Secondary Outcome Measures
 (submitted: April 5, 2018)
Number of Participants with Clinical Effectiveness [ Time Frame: Maximum 8 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Anaemetro I.V. Infusion 500mg Drug Use Investigation
Official Title METRONIDAZOLE IV DRUG USE INVESTIGATION
Brief Summary Secondary Data Collection Study; safety and effectiveness of Anaemetro under Japanese medical practice
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients who satisfy all of the inclusion criteria are subject to this study.
Condition
  • Anaerobic Infection
  • Infectious Enterocolitis
  • Amebic Dysentery
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 5, 2018)
107
Original Actual Enrollment Same as current
Actual Study Completion Date August 2017
Actual Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.

Exclusion Criteria:

  • No exclusion criteria are set out in this study.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03491228
Other Study ID Numbers A6831007
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: 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.
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date December 2018