Clinical trial NCT01064024: Evaluate the Safety and Efficacy of Phenazopyridine Hydrochloride Tablets, USP 200 mg vs. Placebo
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Urinary Tract Infections
Keywords: uUTI
Pain or burning associated with Uncomplicated Urinary Tract Infections
Lead sponsor: Amneal Pharmaceuticals, LLC
Sponsor class: INDUSTRY
Collaborators: name: Oxford Pharmaceutical Resources, Inc.
name: Sristek Clinical Research Solutions Limited
name: Biostudy Solutions, LLC
First posted: 2010-02-08
Enrollment: 233
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


Eligibility 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.

Primary outcomes:
measure: proportion of subjects in each treatment group who demonstrate reduction in pain or burning when passing urine.
timeFrame: 24 hrs after first dose and 48 hrs after second dose
Secondary outcomes:
Other outcomes:
Locations:
city: Totowa
country: United States
facility: Oxford Pharmaceutical Resources, Inc.
state: New Jersey
Study officials:
References: