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

NCT ID: NCT01064024

Last Updated: 2013-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 233 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2010-12-31

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)

Conditions

Pain; Urinary Tract Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Phenazopyridine Hydrochloride Tablets, USP 200 mg

Group Type: ACTIVE_COMPARATOR

Phenazopyridine Hydrochloride

Intervention Type: DRUG

Tablets, 200 mg, every 8 hours for 48 hours.

Placebo

Matching placebo to the phenazopyridine hydrochloride tablets

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Tablets, every 8 hours for 48 hours

Interventions

Phenazopyridine Hydrochloride

Tablets, 200 mg, every 8 hours for 48 hours.

Intervention Type: DRUG

Placebo

Tablets, every 8 hours for 48 hours

Intervention Type: DRUG

Other Intervention Names

Pyridium

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Oxford Pharmaceutical Resources, Inc.

INDUSTRY

Sponsor Role: collaborator

Sristek Clinical Research Solutions Limited

INDUSTRY

Sponsor Role: collaborator

Biostudy Solutions, LLC

UNKNOWN

Sponsor Role: collaborator

Amneal Pharmaceuticals, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Oxford Pharmaceutical Resources, Inc.

Totowa, New Jersey, United States

Countries

United States

Other Identifiers

AM-PHN-001

Identifier Type: -

Identifier Source: org_study_id