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

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)

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)

Study Overview

• Status: Completed
• Conditions: Pain; Urinary Tract Infections
• Intervention / Treatment: Drug: Phenazopyridine Hydrochloride; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 233
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Totowa, New Jersey, United States, 07512
      • Oxford Pharmaceutical Resources, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Amneal Pharmaceuticals, LLC
• Collaborators: Oxford Pharmaceutical Resources, Inc.; Sristek Clinical Research; Biostudy Solutions, LLC

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: February 4, 2010
• First Submitted That Met QC Criteria: February 5, 2010
• First Posted (Estimate): February 8, 2010

Study Record Updates

• Last Update Posted (Estimate): January 29, 2013
• Last Update Submitted That Met QC Criteria: January 24, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: uUTI; Pain or burning associated with Uncomplicated Urinary Tract Infections
• Additional Relevant MeSH Terms: Urologic Diseases; Infections; Urinary Tract Infections
• Other Study ID Numbers: AM-PHN-001