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ABOUT THIS STUDY
Secondary Data Collection Study; safety and effectiveness of Anaemetro under Japanese medical
practice
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
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
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.
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Anaerobic Infection, Infectious Enterocolitis, Amebic DysenteryAnaemetro I.V. Infusion 500mg Drug Use Investigation
NCT03491228
ALL GENDERS
0+
years
MULTIPLE SITES
Advanced Information
| 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 |
| ||||
| 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 | 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:
Exclusion Criteria:
| ||||
| Sex/Gender |
| ||||
| 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 |
| ||||
| IPD Sharing Statement |
| ||||
| Responsible Party | Pfizer | ||||
| Study Sponsor | Pfizer | ||||
| Collaborators | Not Provided | ||||
| Investigators |
| ||||
| PRS Account | Pfizer | ||||
| Verification Date | December 2018 | ||||