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

This study has been completed.
Sponsor:
Collaborators:
Oxford Pharmaceutical Resources, Inc.
Sristek Clinical Research
Biostudy Solutions, LLC
Information provided by (Responsible Party):
Amneal Pharmaceuticals, LLC
ClinicalTrials.gov Identifier:
NCT01064024
First received: February 4, 2010
Last updated: January 24, 2013
Last verified: January 2013
History of Changes
  Purpose

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)


Condition Intervention Phase
Pain
Urinary Tract Infections
 Drug: Phenazopyridine Hydrochloride
Drug: Placebo
 Phase 3

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Amneal Pharmaceuticals, LLC:

Primary Outcome Measures:
  • proportion of subjects in each treatment group who demonstrate reduction in pain or burning when passing urine. [ Time Frame: 24 hrs after first dose and 48 hrs after second dose ] [ Designated as safety issue: No ]

Enrollment: 233
Study Start Date: December 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Phenazopyridine Hydrochloride Tablets, USP 200 mg Drug: Phenazopyridine Hydrochloride
Tablets, 200 mg, every 8 hours for 48 hours.
Other Name: Pyridium
Placebo Comparator: Placebo
Matching placebo to the phenazopyridine hydrochloride tablets
 Drug: Placebo
Tablets, every 8 hours for 48 hours

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01064024

Locations
United States, New Jersey
Oxford Pharmaceutical Resources, Inc.
Totowa, New Jersey, United States, 07512
Sponsors and Collaborators
Amneal Pharmaceuticals, LLC
Oxford Pharmaceutical Resources, Inc.
Sristek Clinical Research
Biostudy Solutions, LLC
  More Information

No publications provided

Responsible Party: Amneal Pharmaceuticals, LLC
ClinicalTrials.gov Identifier: NCT01064024     History of Changes
Other Study ID Numbers: AM-PHN-001
Study First Received: February 4, 2010
Last Updated: January 24, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Amneal Pharmaceuticals, LLC:
uUTI
Pain or burning associated with Uncomplicated Urinary Tract Infections

Additional relevant MeSH terms:
Urinary Tract Infections
Infection
Urologic Diseases

ClinicalTrials.gov processed this record on June 17, 2013