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NCT03535558 · ClinicalTrials.gov registry record
Fluoroquinolone Associated Disability
A clinical trial, sponsored by Janssen Research & Development.
- Completed
- Registry status
- 239,306
- Enrollment target
NCT03535558 is a clinical trial that has completed, run by Janssen Research & Development. The registered enrollment target is 239,306 participants.
The verdict
NCT03535558 has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- 239,306 participants
- Enrollment target
Study Summary
The purpose of this study is to: 1) describe drug utilization for Fluoroquinolone(FQ), Azithromycin (AZ) and Sulfamethoxazole/Trimethoprim(ST) in the entire Truven MarketScan Commercial Claims and Encounters database (CCAE) database, and specifically among individuals in the Health and Productivity Management (HPM) during the observation period; 2) describe the rate of disability associated with 2 or more System Organ Class adverse events (SOC AEs) and exposure to FQs for several acute, uncomplicated indications; and 3) compare the rates of disability for 2 or more SOC AEs and exposure to FQs and AZ/ST for the same indications.
Interventions
- DRUG Fluoroquinolone (FQ)
- DRUG Azithromycin (AZ)
- DRUG Sulfamethoxazole/Trimethoprim (ST) Fixed Dose Combination
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 239,306 participants |
| Start Date | 2018-05-17 |
| Est. Completion | 2018-12-31 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03535558
The ClinicalTrials.gov registry entry for NCT03535558 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 239,306 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Fluoroquinolone (FQ) is the first listed.
NCT03535558 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03535558 about?
NCT03535558 is a clinical study titled "Fluoroquinolone Associated Disability". The purpose of this study is to: 1) describe drug utilization for Fluoroquinolone(FQ), Azithromycin (AZ) and Sulfamethoxazole/Trimethoprim(ST) in the entire Truven MarketScan Commercial Claims and Encounters database (CCAE) database, and specifically among individuals in the Health and Productivity ...
What is the current status of trial NCT03535558?
This trial is currently completed. The enrollment target is 239,306 participants. The study started on 2018-05-17. Estimated completion is 2018-12-31.
What interventions are being tested in trial NCT03535558?
The interventions under investigation include: Fluoroquinolone (FQ) (DRUG), Azithromycin (AZ) (DRUG), Sulfamethoxazole/Trimethoprim (ST) Fixed Dose Combination (DRUG).
Who is sponsoring clinical trial NCT03535558?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
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