Evaluate the Safety and Efficacy of Phenazopyridine Hydrochloride Tablets, USP 200 mg vs. Placebo

Inclusion criteria

• Diagnosis of uncomplicated urinary tract infection (uUTI)
• Must have one of the following uUTI diagnosis
• Cystitis
• Urethritis
• A Positive urine dipstick test showing nitrate or leukocyte esterase (LE)
• Negative pregnancy test (if applicable)
• Must have one or both of the following symptoms of
• pain upon urination
• burning upon urination
• In addition, one of the following symptoms
• Not being able to empty bladder completely
• Pain or discomfort in lower abdomen, or pelvic areas
• Frequent urge to urinate
• Blood in urine
• None

Exclusion criteria

• Any diagnosis of a urinary tract or kidney disorder that is not a uUTI
• A diagnosis of Pyelonephritis (kidney infections when lower uUTI spreads to the upper tract)
• Women with a history of prior use of phenazopyridine hydrochloride
• Women who have taken any systemic anti-infectives within seven days of study participation
• Women with a history of G-6-PD deficiency or hemolytic anemia
• Women who have a known history of anatomical genitourinary (GU) anomalies or GU surgery within the past 6 months
• Women of child bearing age who do not consent to a pregnancy test
• Women who are lactating
• Chronic infection of the urinary tract requiring an intravenous pyelogram (IVP), ultrasound or cystoscopy
• Subjects with clinically significant abnormal results or finding on the screening physical examination, laboratory tests, vital signs or ECG.
• Subjects unable to comprehend the language of the informed consent and the self evaluation scales.
• Subjects with serious acute illness (e.g. pneumonia) or an untreated or unstable medical illness that would likely interfere with assessments of uUTI
• Subjects who have received an investigational medication as part of a drug trial 3 months prior to the baseline study visit
• Subjects with a history of severe drug allergy or hypersensitivity
• Subjects with a known sensitivity to Phenazopyridine, Hyoscyamine, Butabarbital and antibiotics.
• Employees of the investigator or the institution who have direct involvement in the trial or other trials under the direction of the investigator or their associates.