Safety and Efficacy of Phenazopyridine Hydrochloride Tablets, USP 200 mg as an Analgesic for Short-Term Treatment in Female Subjects Suffering From Moderate-to-Severe Pain and Burning Upon Urination Associated With Uncomplicated Urinary Tract Infections (uUTI)

This study has been completed.
Sponsor:
Collaborator:
Symbio, LLC
Information provided by (Responsible Party):
Amneal Pharmaceuticals, LLC
ClinicalTrials.gov Identifier:
NCT01650051
First received: July 19, 2012
Last updated: June 25, 2014
Last verified: June 2014
  Purpose

The primary objective is to evaluate the safety and efficacy of Phenazopyridine HCl Tablets, USP 200 mg as a short term analgesic treatment of pain upon urination associated with Uncomplicated Urinary Tract Infections (uUTI).

The secondary exploratory objective is to evaluate safety and efficacy of Phenazopyridine HCl Tablets, USP 200 mg as a short term analgesic treatment of burning upon urination associated with uUTI.


Condition Intervention Phase
Uncomplicated Urinary Tract Infections
Drug: Placebo of Phenazopyridine Hydrochloride Tables, USP 200 mg
Drug: Phenazopyridine Hydrochloride Tables, USP 200 mg
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, Multi-Center, Parallel-Group, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Phenazopyridine Hydrochloride Tablets, USP 200 mg as an Analgesic for Short-Term Treatment in Female Subjects Suffering From Moderate-to-Severe Pain and Burning Upon Urination Associated With Uncomplicated Urinary Tract Infections (uUTI)

Resource links provided by NLM:


Further study details as provided by Amneal Pharmaceuticals, LLC:

Primary Outcome Measures:
  • Self-assessments [ Time Frame: Designated Intervals for 24 hours ] [ Designated as safety issue: No ]
    The difference between baseline NRS for pain at 0 hours and the NRS for pain score at each scheduled time will be calculated to obtain Pain Intensity Difference (PID) at each time point 92, 4, 6, 8, 16 and 24.


Enrollment: 424
Study Start Date: February 2012
Study Completion Date: February 2014
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo of Phenazopyridine Hydrochloride Tables, USP 200 mg Drug: Placebo of Phenazopyridine Hydrochloride Tables, USP 200 mg
Deep brown maroon colored, film coated round biconvex tablet debossed 'AN" obve '2' on one side and plain on the other side.
Experimental: Phenazopyridine Hydrochloride Tables, USP 200 mg Drug: Phenazopyridine Hydrochloride Tables, USP 200 mg
Deep brown maroon colored, film coated round biconvex tablet debossed 'AN" obve '2' on one side and plain on the other side.

Detailed Description:

Subjects will make separate self-assessments for severity of pain and burning upon urination using the NRS and self-assessments of their discomfort using the GSAS at designated intervals for 24 hours. Subjects will rate the effectiveness of the study medication using the SASMS at a designated interval for 24 hours.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Is willing and able to provide and understand written informed consent for the study.
  • Is a female 18 years of age or older.
  • Has a clinical diagnosis of uncomplicated urinary tract infection (uUTI).
  • Has a reported history indicating a diagnosis of cystitis or urethritis.
  • Has a positive urine dipstick test showing the presence of nitrate or leukocyte esterase.
  • Has moderate to severe pain (score of 4 to 10 inclusive on the NRS) and burning (score of 4-10, inclusive on the NRS) upon urination.
  • Is willing and able to understand and comply with the requirements of the study.
  • Each female subject of childbearing potential (excluding women who are surgically sterilized or postmenopausal for at least 2 years) must have a negative urine pregnancy test at Screening and must be willing to use an acceptable form of birth control during the study. For the purpose of this trial, the following are considered acceptable methods of birth control: oral contraceptives, contraceptive patches, contraceptive implant, vaginal contraceptive, double barrier methods (eg, condom and spermicide), contraceptive injection (Depo-provera®), intrauterine device (IUD), hormonal IUD (Mirena®), and abstinence with a documented second acceptable method of birth control should the subject become sexually active.

Exclusion Criteria:

  • Is pregnant or breastfeeding during the study.
  • Has a diagnosis of a urinary tract or kidney disorder that is not a uUTI. Has a diagnosis of pyelonephritis (kidney infections when lower uUTI spreads to the upper tract).
  • Has taken an analgesic within 1 day prior to Visit 1.
  • Has taken any systemic anti-infectives within 7 days prior to Visit 1.
  • Has a history of G-6-PD deficiency or hemolytic anemia.
  • Has a known history of anatomical genitourinary (GU) anomalies or GU surgery within 6 months prior to Visit 1.
  • Has a chronic infection of the urinary tract requiring an intravenous pyelogram (IVP), ultrasound, or cystoscopy.
  • Is unable to comprehend the language of the informed consent and the self-evaluation scales.
  • Has serious acute illness (e.g., pneumonia) or an untreated or unstable medical illness that would likely interfere with assessments of uUTI.
  • Has received an investigational medication as part of a drug trial within 3 months prior to Visit 1.
  • Is currently participating in any other clinical study.
  • Has a history of severe drug allergy or hypersensitivity, including to phenazopyridine HCl or to any component of the study medications.
  • Consumes excessive amounts of alcohol, abuses drugs, or has any condition that would compromise compliance with this protocol.
  • Previous participation in this study.
  • Any clinically significant condition or situation, that in the opinion of the Investigator would interfere with the study evaluations or optimal participation in the study.
  • Prior use of phenazopyridine product within 3 years of enrollment.
  • Is an employee or direct relative of the study site or Investigator.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01650051

Locations
United States, New York
Symbio, LLC
Port Jefferson, New York, United States, 11777
Sponsors and Collaborators
Amneal Pharmaceuticals, LLC
Symbio, LLC
  More Information

No publications provided

Responsible Party: Amneal Pharmaceuticals, LLC
ClinicalTrials.gov Identifier: NCT01650051     History of Changes
Other Study ID Numbers: AM-PHN-004
Study First Received: July 19, 2012
Last Updated: June 25, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Urinary Tract Infections
Stress, Psychological
Infection
Urologic Diseases
Behavioral Symptoms
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 26, 2014