check_circleStudy Completed
Cystitis / Pyelonephritis / Cystic fibrosis / Anthrax
Bayer Identifier:
18235
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Special Drug Use Investigation of Ciproxan injection in pediatrics
Trial purpose
The objective in this study is collecting post-marketing information on the safety and efficacy of Ciproxan injection under the routine clinical practice.
Key Participants Requirements
Sex
BothAge
NaN - 14 YearsTrial summary
Enrollment Goal
48Trial Dates
July 2016 - June 2019Phase
N/ACould I Receive a placebo
NoProducts
Cipro IV (Ciprofloxacin, BAYQ3939)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many Locations, Japan |
Primary Outcome
- Number of musculoskeletal adverse events.date_rangeTime Frame:Up to 12 monthsenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Existence of Bacillus anthracis or Escherichia coli or Pseudomonas aeruginosa in urine(Y/N)date_rangeTime Frame:At week 6enhanced_encryptionNoSafety Issue:
- Number of participants with adverse events as measure of safety and tolerabilitydate_rangeTime Frame:At week 4enhanced_encryptionYesSafety Issue:
- EfficacyRated by physician with 3-grade scaledate_rangeTime Frame:Up to 2 weeksenhanced_encryptionNoSafety Issue:
- Number of participants with adverse events based on abnormal laboratory measurementsdate_rangeTime Frame:At week 4enhanced_encryptionYesSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A