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

Study Overview
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Brief Summary
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This study will evaluate the safety and efficacy of Phenazopyridine Hydrochloride Tablets, USP 200 mg as a short term analgesic treatment for the primary symptoms of pain or burning when passing urine associated with uncomplicated urinary tract infections (uUTI)

Official Title
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A Double Blind, Randomized, Parallel Controlled Study to Evaluate the Safety and Efficacy of Phenazopyridine Hydrochloride Tablets, USP 200 mg vs. Placebo as a Urinary Analgesic for Short Term Treatment in Female Subjects Suffering From Pain or Burning When Passing Urine Associated With Uncomplicated Urinary Tract Infections (uUTI)

Conditions
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Pain, Urinary Tract Infections

Intervention / Treatment
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* Drug: Phenazopyridine Hydrochloride
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Phenazopyridine Hydrochloride Tablets, USP 200 mg<br> | Drug: Phenazopyridine Hydrochloride<br>* Tablets, 200 mg, every 8 hours for 48 hours.<br>* Other names: Pyridium;|
| Placebo Comparator: Placebo<br>Matching placebo to the phenazopyridine hydrochloride tablets | Drug: Placebo<br>* Tablets, every 8 hours for 48 hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of subjects in each treatment group who demonstrate reduction in pain or burning when passing urine. |  | 24 hrs after first dose and 48 hrs after second dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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uUTI, Pain or burning associated with Uncomplicated Urinary Tract Infections