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Anaemetro I.V. Infusion 500mg Drug Use Investigation

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NCT03491228

Last updated on November 5, 2019
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Study Location
Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Anaerobic Infection, Infectious Enterocolitis, Amebic Dysentery
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- No exclusion criteria are set out in this study.

NCT03491228
Pfizer
Completed
Anaemetro I.V. Infusion 500mg Drug Use Investigation

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Descriptive Information
Brief TitleAnaemetro I.V. Infusion 500mg Drug Use Investigation
Official TitleMETRONIDAZOLE IV DRUG USE INVESTIGATION
Brief SummarySecondary Data Collection Study; safety and effectiveness of Anaemetro under Japanese medical practice
Detailed DescriptionNot Provided
Study TypeObservational
Study DesignObservational Model: Other
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodProbability Sample
Study PopulationPatients who satisfy all of the inclusion criteria are subject to this study.
Condition
  • Anaerobic Infection
  • Infectious Enterocolitis
  • Amebic Dysentery
InterventionNot Provided
Study Groups/CohortsNot 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 StatusCompleted
Actual Enrollment
 (submitted: April 5, 2018)		107
Original Actual EnrollmentSame as current
Actual Study Completion DateAugust 2017
Actual Primary Completion DateAugust 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
AgesChild, Adult, Older Adult
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesNot Provided
Removed Location Countries  
 
Administrative Information
NCT NumberNCT03491228
Other Study ID NumbersA6831007
Has Data Monitoring CommitteeNo
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/da....
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateDecember 2018

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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