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Phenazopyridine Tables, USP

Phase 3

Uncomplicated Urinary Tract Infections | Small molecule | Nephrology |Amneal Pharmaceuticals, Inc.|Last Updated: Jun 26, 2014

Success Probability
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Market & Valuation
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment424
FDA Designations
No designations recorded
Clinical trial landscape

Phenazopyridine Tables, USP · 1 trial · 1 indication

Phase 3 1
NCT01650051Safety and Efficacy of Phenazopyridine Hydrochloride Tablets, USP 200 mg as an Analgesic for Short-Term Treatment in Female Subjects Suffering From Moderate-to-Severe Pain and Burning Upon Urination Associated With Uncomplicated Urinary Tract Infections (uUTI)Uncomplicated Urinary Tract Infections
COMPLETED424 Analytics
PHASE3COMPLETED
Safety and Efficacy of Phenazopyridine Hydrochloride Tablets, USP 200 mg as an Analgesic for Short-Term Treatment in Female Subjects Suffering From Moderate-to-Severe Pain and Burning Upon Urination Associated With Uncomplicated Urinary Tract Infections (uUTI)
Uncomplicated Urinary Tract Infections
NCT01650051424
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Study Endpoints
Primary Endpoints
Self-assessments
Designated Intervals for 24 hours

The difference between baseline NRS for pain at 0 hours and the NRS for pain score at each scheduled time will be calculated to obtain Pain Intensity Difference (PID) at each time point 92, 4, 6, 8, 16 and 24.

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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Placebo of Phenazopyridine Hydrochloride Tables, USP 200 mgPLACEBO_COMPARATOR -
Phenazopyridine Hydrochloride Tables, USP 200 mgEXPERIMENTAL -
Interventions
NameTypeDescription
Placebo of Phenazopyridine Hydrochloride Tables, USP 200 mgDRUGDeep brown maroon colored, film coated round biconvex tablet debossed 'AN" obve '2' on one side and plain on the other side.
Phenazopyridine Hydrochloride Tables, USP 200 mgDRUGDeep brown maroon colored, film coated round biconvex tablet debossed 'AN" obve '2' on one side and plain on the other side.
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Eligibility Criteria
Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Is willing and able to provide and understand written informed consent for the study. * Is a female 18 years of age or older. * Has a clinical diagnosis of uncomplicated urinary tract infection (uUTI). * Has a reported history indicating a diagnosis of cystitis or urethritis. ...

Countries:United States
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