Safety and Efficacy of PP4001 for the Treatment of Symptoms Associated With Uncomplicated Urinary Tract Infection
Public ClinicalTrials.gov record NCT01406587. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group Evaluation of the Efficacy and Safety of 50 mg, 100 mg and 200 mg PP4001 Twice Daily for the Treatment of Burning During Urination, Pain, and Urination Frequency Associated With Uncomplicated Urinary Tract Infection
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01406587
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 261 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 2011 (Type not available)
- Primary completion
- Oct 2011 (Actual)
- Completion
- Oct 2011 (Actual)
- Last update posted
- Oct 19, 2011
2011
United States locations
- U.S. sites
- 25
- U.S. states
- 14
- U.S. cities
- 23
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Drug Research and Analysis Corp. | Montgomery | Alabama | 36106 | — |
| Mesa Family Medical Center/Clincal Research Advantage | Mesa | Arizona | 85203 | — |
| Desert Clinical Research/Clinical Research Advantage | Mesa | Arizona | 85213 | — |
| Central Phoenix Medical Clinic/Clinical Research Advantage | Phoenix | Arizona | 85020 | — |
| Northern California Research | Sacramento | California | 95821 | — |
| Medical Center for Clinical Research | San Diego | California | 92108 | — |
| Women's Health Care Research | San Diego | California | 92123 | — |
| Tampa Bay Medical Research | Clearwater | Florida | 33761 | — |
| Health Awareness, Inc. | Jupiter | Florida | 33458 | — |
| Urology Center of Central Florida/Triquest Clinical Research Inc. | Saint Cloud | Florida | 34769 | — |
| Soapstone Center for Clinical Research | Decatur | Georgia | 30034 | — |
| Hutzel Women's Health Research | Detroit | Michigan | 48201 | — |
| Bellevue Family Practice/Clinical Research Advantage | Bellevue | Nebraska | 68005 | — |
| Clinical Research Center of Nevada | Las Vegas | Nevada | 89123 | — |
| AccuMed Research Associates | Garden City | New York | 11530 | — |
| Wake Research Associates | Raleigh | North Carolina | 27612 | — |
| Hawthorne Medical Research, Inc. | Winston-Salem | North Carolina | 27103 | — |
| Hometown Urgent Care and Research | Groveport | Ohio | 43125 | — |
| Hometown Urgent Care and Research | Springfield | Ohio | 45504 | — |
| Ellipsis Research Group, LLC | Columbia | South Carolina | 29201 | — |
| Palmetto Clinical Research, LLC | Greenville | South Carolina | 29615 | — |
| InvestiClin Research | Brentwood | Tennessee | 37027 | — |
| Advanced Research Associates | Corpus Christi | Texas | 78414 | — |
| R/D Clinical Research, Inc. | Lake Jackson | Texas | 77566 | — |
| Clinical Trials of Texas | San Antonio | Texas | 78229 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01406587, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 19, 2011 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01406587 live on ClinicalTrials.gov.