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

Amneal Pharmaceuticals

Status and phase

Completed

Phase 3

Conditions

Urinary Tract Infections

Pain

Treatments

Drug: Phenazopyridine Hydrochloride

Drug: Placebo

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT01064024

AM-PHN-001

Details and patient eligibility

About

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)

Enrollment

233 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.