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

Phase 3

Completed

• Conditions: Pain; Urinary Tract Infections
• Interventions: Drug: Phenazopyridine Hydrochloride; Drug: Placebo

• Registration Number: NCT01064024
• Lead Sponsor: Amneal Pharmaceuticals, LLC

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2010-02-04
• Study First Submitted QC: 2010-02-05
• Study First Posted: 2010-02-08
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2013-01
• Disposition First Submitted: 2013-01-24
• Disposition First Submitted QC: 2013-01-24
• Last Update Submitted: 2013-01-24
• Disposition First Posted: 2013-01-29
• Last Update Posted: 2013-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 233

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Phenazopyridine Hydrochloride Tablets, USP 200 mg	Phenazopyridine Hydrochloride	-
Placebo	Placebo	Matching placebo to the phenazopyridine hydrochloride tablets

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Oxford Pharmaceutical Resources, Inc.; 🇺🇸 Totowa, New Jersey, United States