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Trial record 1 of 1 for:    NCT02680665
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Ameparomo Capsules 250 mg Drug Use Investigation

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ClinicalTrials.gov Identifier: NCT02680665
Recruitment Status : Completed
First Posted : February 11, 2016
Last Update Posted : March 18, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date February 9, 2016
First Posted Date February 11, 2016
Last Update Posted Date March 18, 2019
Actual Study Start Date October 19, 2015
Actual Primary Completion Date December 21, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 9, 2016)
Number of Paticipants With Adverse Events (AEs) by Seriousness and Relationship to Treatment [ Time Frame: Maximum 10 days ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02680665 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: February 9, 2016)
Number of Participants With Clinical Response of Cure [ Time Frame: Maximum 3 months ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Ameparomo Capsules 250 mg Drug Use Investigation
Official Title AMEPAROMO CAPSULES 250 MG DRUG USE INVESTIGATION
Brief Summary This Study is intended to evaluate the safety and effectiveness of Ameparomo Capsules 250 mg under actual medical practice.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Sites of infection department, internal medicine, and other relevant departments.
Condition Intestinal Amebiasis
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: February 26, 2019)
120
Original Estimated Enrollment
 (submitted: February 9, 2016)
200
Actual Study Completion Date December 21, 2018
Actual Primary Completion Date December 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
Ages 15 Years to 99 Years   (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 NCT02680665
Other Study ID Numbers B3391001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not 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/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 March 2019