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

NCT01064024 | Completed Phase 3 DMC

• 1 other identifier: AM-PHN-001
• Study Type: interventional
• Target: 233
• Locations: 1 country
• Sites: 1

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

Keywords

uUTI; Pain or burning associated with Uncomplicated Urinary Tract Infections

Outcome Measures

Primary Outcomes (1)

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

  24 hrs after first dose and 48 hrs after second dose

Study Arms (2)

Phenazopyridine Hydrochloride Tablets, USP 200 mg

ACTIVE COMPARATOR

Drug: Phenazopyridine Hydrochloride

Placebo

PLACEBO COMPARATOR

Matching placebo to the phenazopyridine hydrochloride tablets

Drug: Placebo

Interventions

Phenazopyridine Hydrochloride DRUG

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

Also known as: Pyridium

Phenazopyridine Hydrochloride Tablets, USP 200 mg

Placebo DRUG

Tablets, every 8 hours for 48 hours

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amneal Pharmaceuticals, LLC: lead
• Oxford Pharmaceutical Resources, Inc.: collaborator
• Sristek Clinical Research Solutions Limited: collaborator
• Biostudy Solutions, LLC: collaborator

Study Sites (1)

Oxford Pharmaceutical Resources, Inc.

Totowa, New Jersey, 07512, United States

Location

MeSH Terms

Conditions

Pain; Urinary Tract Infections

Interventions

Phenazopyridine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Aminopyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2010
• First Posted: February 8, 2010
• Study Start: December 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: January 29, 2013

Record last verified: 2013-01

Locations

US (1)