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

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: Female

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)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

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.