Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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

Condition or disease
Anaerobic Infection Infectious Enterocolitis Amebic Dysentery

Layout table for study information
Study Type : Observational
Actual Enrollment : 107 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: METRONIDAZOLE IV DRUG USE INVESTIGATION
Actual Study Start Date : July 2015
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


  2. 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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients who satisfy all of the inclusion criteria are subject to this study.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03491228


Sponsors and Collaborators
Pfizer
Investigators
Layout table for investigator information
Study Director: Pfizer CT.gov Call Center Pfizer
  Study Documents (Full-Text)

Documents provided by Pfizer:
Study Protocol  [PDF] January 10, 2017
Statistical Analysis Plan  [PDF] August 18, 2017


Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03491228     History of Changes
Other Study ID Numbers: A6831007
First Posted: April 9, 2018    Key Record Dates
Results First Posted: December 28, 2018
Last Update Posted: December 28, 2018
Last Verified: December 2018
Individual Participant Data (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.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Dysentery, Amebic
Enterocolitis
Dysentery
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Intestinal Diseases, Parasitic
Parasitic Diseases
Amebiasis
Protozoan Infections