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

Pain Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01064024
• Other study ID #: AM-PHN-001
• Status: Completed
• Phase: Phase 3
• First received: February 4, 2010
• Last updated: January 24, 2013
• Start date: December 2009
• Est. completion date: December 2010

Study information

• Verified date: January 2013
• Source: Amneal Pharmaceuticals, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 233
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infection
• Pain
• Urinary Tract Infections

Intervention

Drug:
• Phenazopyridine Hydrochloride
Tablets, 200 mg, every 8 hours for 48 hours.
• Placebo
Tablets, every 8 hours for 48 hours

Locations

Country	Name	City	State
United States	Oxford Pharmaceutical Resources, Inc.	Totowa	New Jersey

Sponsors (4)

Lead Sponsor	Collaborator
Amneal Pharmaceuticals, LLC	Biostudy Solutions, LLC, Oxford Pharmaceutical Resources, Inc., Sristek Clinical Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No