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

Condition(s) targeted: Pain; Urinary Tract Infections

Intervention: Phenazopyridine Hydrochloride (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Amneal Pharmaceuticals, LLC

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: 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)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: proportion of subjects in each treatment group who demonstrate reduction in pain or burning when passing urine.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

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.

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

Starting date: December 2009
Last updated: January 24, 2013