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Ameparomo Capsules 250 mg Drug Use Investigation

Last updated on November 16, 2019

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Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Intestinal Amebiasis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
15-99 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Patients with no history of using this product

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.

NCT02680665
Pfizer
Completed
Ameparomo Capsules 250 mg Drug Use Investigation

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Descriptive Information
Brief TitleAmeparomo Capsules 250 mg Drug Use Investigation
Official TitleAMEPAROMO CAPSULES 250 MG DRUG USE INVESTIGATION
Brief SummaryThis Study is intended to evaluate the safety and effectiveness of Ameparomo Capsules 250 mg under actual medical practice.
Detailed DescriptionNot Provided
Study TypeObservational
Study DesignObservational Model: Cohort
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodProbability Sample
Study PopulationSites of infection department, internal medicine, and other relevant departments.
ConditionIntestinal Amebiasis
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: February 26, 2019)
120
Original Estimated Enrollment
 (submitted: February 9, 2016)
200
Actual Study Completion DateDecember 21, 2018
Actual Primary Completion DateDecember 21, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients with no history of using this product

Exclusion Criteria:

  • No exclusion criteria are set out in this study.
Sex/Gender
Sexes Eligible for Study:All
Ages15 Years to 99 Years   (Child, 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 NumberNCT02680665
Other Study ID NumbersB3391001
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
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 DateMarch 2019

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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

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Contact

[email protected]

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