Safety and Efficacy of PP4001 for the Treatment of Symptoms Associated With Uncomplicated Urinary Tract Infection

NCT ID: NCT01406587

Last Updated: 2011-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 261 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2011-10-31

Brief Summary

PP4001 is a medication not yet approved by the US FDA. This is a phase 2, multi-center, randomized, double-blind study of 3 doses of PP4001 versus placebo in the treatment of symptoms associated with uncomplicated urinary tract infection. After the screening, patients are randomized to receive one of three doses of PP4001 or placebo. Patients are screened and randomized on the same day, and take 4 doses of study drug, one dose every 12 hours. Data about uncomplicated urinary tract infection symptoms are collected from the subjects on electronic handheld devices throughout the 48-hour study period. The primary endpoint is burning during urination.

Conditions

Urinary Tract Infection

Study Design

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

Study Groups

PP4001 50 mg

Group Type: EXPERIMENTAL

PP4001

Intervention Type: DRUG

50 mg, 1 dose every 12 hours x 4 doses

PP4001 100 mg

Group Type: EXPERIMENTAL

PP4001

Intervention Type: DRUG

100 mg, 1 dose every 12 hours x 4 doses

PP4001 200 mg

Group Type: EXPERIMENTAL

PP4001

Intervention Type: DRUG

200 mg, 1 dose every 12 hours x 4 doses

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo, 1 dose every 12 hours x 4 doses

Interventions

PP4001

50 mg, 1 dose every 12 hours x 4 doses

Intervention Type: DRUG

PP4001

100 mg, 1 dose every 12 hours x 4 doses

Intervention Type: DRUG

PP4001

200 mg, 1 dose every 12 hours x 4 doses

Intervention Type: DRUG

Placebo

Placebo, 1 dose every 12 hours x 4 doses

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Female subjects must be ≥ 18 and ≤ 75 years of age at the time of consent.
• Females not of childbearing potential (FNCBP) are eligible for randomization. FNCBP are defined as postmenopausal women with their last menstrual cycle (without exogenous hormone therapy) completed more than 12 consecutive months before screening or women who are surgically sterilized (hysterectomy, oophorectomy, or tubal ligation). Females of childbearing potential also are eligible for randomization provided they are not pregnant or nursing and employ appropriate methods of contraceptives for the duration of the trial. Medically acceptable forms of contraception include abstinence, oral contraceptives, intra-uterine devices, injectable hormonals, intra-vaginal rings, or double-barrier methods (condom plus spermicide), for at least 1 month prior to treatment. Subjects in a monogamous, long term relationship with a partner who has had a vasectomy at least 3 months prior to screening are also study eligible.
• Diagnosis of uncomplicated UTI as defined by having both of the following:
• Presence of supporting symptoms including new onset (within 1 week) of urination frequency, painful urination, and/or urgency.
• Positive dipstick test for leukocyte esterase.
• Demonstration of moderate to severe burning during urination as measured by a score of at least six (6) on the 11-point rating scale for Burning During Urination during screening.
• A negative urine pregnancy test for women of childbearing potential.
• If subject has a chronic, clinically stable disease that requires medication, medication to treat that disease must be stable for at least 30 days prior to screening.
• Ability to perform study procedures, including the completion of electronic diary assessments, and supply the necessary information to the study personnel as required by the protocol.
• A signed informed consent form in which the subject agrees to participate after the study has been fully explained.

Exclusion Criteria

• Clinically significant medical history or a clinically significant abnormal finding on the physical exam, vital signs or ECG at screening, including serious acute illness (e.g. pneumonia), gastrointestinal illness that would interfere with study drug absorption, or an untreated or unstable medical illness that would likely interfere with the study assessments.
• At risk in terms of the precautions, warnings, and contraindications in the package insert for phenazopyridine hydrochloride including:
• Known hypersensitivity to phenazopyridine hydrochloride (Defined by a history of allergic or adverse response to the drug).
• Renal failure or insufficiency (Defined as having a history of abnormal renal function or as having a known renal disease).
• History of hepatic disease or failure (Defined as having known liver disease or having elevated LFTs (> 2 times the ULN) on previous laboratory testing. Patients who would not otherwise have such testing are not required to undergo special study labs).
• Known G-6-PD (glucose-6-phosphate dehydrogenase) deficiency.
• Prior use of a phenazopyridine product within 6 months of the first dose of study drug and throughout the study.
• Use of any prescription analgesic medication (e.g. opioids, prescription nonsteroidal anti-inflammatory drugs (NSAID), etc.) for urinary tract pain or other pain (headache, back pain, joint pain, dental pain, sore muscles, etc) within one and a half (1.5) dosing intervals for that medication before the firs dose of study drug, and throughout the study.
• Use of any systemic antibiotic within seven (7) days of study participation.
• Subjects with complaint of abnormal vaginal discharge.
• Current diagnosis or suspicion of complicated UTI or systemic infection based on one or more of the following:
• Known presence of an anatomic or functional abnormality.
• Presence of a urinary catheter.
• Infection of the urinary tract requiring an intravenous pyelogram (IVP), ultrasound or cystoscopy.
• Clinical signs of systemic infection such as fever (oral or tympanic temperature >38 degrees Celsius), costovertebral pain or tenderness, rigors, nausea or vomiting.
• Subjects unable to comprehend the language of the informed consent and the self evaluation scales.
• Subjects who, in the opinion of the investigator, are not appropriate for, or are unable, or unwilling to undergo antibiotic treatment for uncomplicated urinary tract infection.
• Subjects with complaint of abnormal vaginal bleeding defined as different from the patient's usual menstrual period flow and timing.
• Subjects with known allergy to multivitamin or any component of the multivitamin.
• Currently participating in a clinical trial or has received an experimental drug or used an experimental device in the last 30 days prior to admission into this study.
• Subjects who, in the opinion of the investigator, are unsuitable for enrollment, unlikely to complete the course of study medication treatment, or unlikely to attend the End of Study visit.
• Subjects who are unable or unwilling to comply with the use of an electronic subject diary.
• 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
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Pinnacle Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Pinnacle Pharmaceuticals

Principal Investigators

Suma Krishnan

Role: STUDY_DIRECTOR

Pinnacle Pharmaceuticals

Locations

Drug Research and Analysis Corp.

Montgomery, Alabama, United States

Mesa Family Medical Center/Clincal Research Advantage

Mesa, Arizona, United States

Desert Clinical Research/Clinical Research Advantage

Mesa, Arizona, United States

Central Phoenix Medical Clinic/Clinical Research Advantage

Phoenix, Arizona, United States

Northern California Research

Sacramento, California, United States

Medical Center for Clinical Research

San Diego, California, United States

Women's Health Care Research

San Diego, California, United States

Tampa Bay Medical Research

Clearwater, Florida, United States

Health Awareness, Inc.

Jupiter, Florida, United States

Urology Center of Central Florida/Triquest Clinical Research Inc.

Saint Cloud, Florida, United States

Soapstone Center for Clinical Research

Decatur, Georgia, United States

Hutzel Women's Health Research

Detroit, Michigan, United States

Bellevue Family Practice/Clinical Research Advantage

Bellevue, Nebraska, United States

Clinical Research Center of Nevada

Las Vegas, Nevada, United States

AccuMed Research Associates

Garden City, New York, United States

Wake Research Associates

Raleigh, North Carolina, United States

Hawthorne Medical Research, Inc.

Winston-Salem, North Carolina, United States

Hometown Urgent Care and Research

Groveport, Ohio, United States

Hometown Urgent Care and Research

Springfield, Ohio, United States

Ellipsis Research Group, LLC

Columbia, South Carolina, United States

Palmetto Clinical Research, LLC

Greenville, South Carolina, United States

InvestiClin Research

Brentwood, Tennessee, United States

Advanced Research Associates

Corpus Christi, Texas, United States

R/D Clinical Research, Inc.

Lake Jackson, Texas, United States

Clinical Trials of Texas

San Antonio, Texas, United States

Countries

United States

Other Identifiers

PP4001.301

Identifier Type: -

Identifier Source: org_study_id