Urinary Tract InfectionPhase 2NCT01406587
Safety and Efficacy of PP4001 for the Treatment of Symptoms Associated With Uncomplicated Urinary Tract Infection
A Phase 2 study testing PP4001 in people with Urinary Tract Infection, run by Pinnacle Pharmaceuticals, Inc. at 25 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Urinary Tract Infection
- What is being tested?
- PP4001
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 261 participants
- Where
- 25 sitesUnited States
- Study dates
- Jul 2011to Oct 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
Bellevue Family Practice/Clinical Research Advantage
Bellevue, Nebraska, 68005
InvestiClin Research
Brentwood, Tennessee, 37027
Tampa Bay Medical Research
Clearwater, Florida, 33761
Ellipsis Research Group, LLC
Columbia, South Carolina, 29201
Advanced Research Associates
Corpus Christi, Texas, 78414
Soapstone Center for Clinical Research
Decatur, Georgia, 30034
Hutzel Women's Health Research
Detroit, Michigan, 48201
AccuMed Research Associates
Garden City, New York, 11530
Palmetto Clinical Research, LLC
Greenville, South Carolina, 29615
Hometown Urgent Care and Research
Groveport, Ohio, 43125
Health Awareness, Inc.
Jupiter, Florida, 33458
R/D Clinical Research, Inc.
Lake Jackson, Texas, 77566
Clinical Research Center of Nevada
Las Vegas, Nevada, 89123
Mesa Family Medical Center/Clincal Research Advantage
Mesa, Arizona, 85203
Desert Clinical Research/Clinical Research Advantage
Mesa, Arizona, 85213
Drug Research and Analysis Corp.
Montgomery, Alabama, 36106
Central Phoenix Medical Clinic/Clinical Research Advantage
Phoenix, Arizona, 85020
Wake Research Associates
Raleigh, North Carolina, 27612
Northern California Research
Sacramento, California, 95821
Urology Center of Central Florida/Triquest Clinical Research Inc.
Saint Cloud, Florida, 34769
Clinical Trials of Texas
San Antonio, Texas, 78229
Medical Center for Clinical Research
San Diego, California, 92108
Women's Health Care Research
San Diego, California, 92123
Hometown Urgent Care and Research
Springfield, Ohio, 45504
Hawthorne Medical Research, Inc.
Winston-Salem, North Carolina, 27103
About this study
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
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
- Being tested
- PP4001, Placebo
- Keywords
- Burning, Dysuria, Frequency, Pain, Uncomplicated Urinary Tract Infection, Uncomplicated UTI, Urinary Tract Infection, UTI, Burning during urination associated with uncomplicated urinary tract infection, Urination frequency associated with uncomplicated urinary tract infection, Pain associated with uncomplicated urinary tract infection
- Medical subject headings
- Urinary Tract Infections, Paresthesia, Dysuria, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PP4001Drug
50 mg, 1 dose every 12 hours x 4 doses
PP4001Drug
100 mg, 1 dose every 12 hours x 4 doses
PP4001Drug
200 mg, 1 dose every 12 hours x 4 doses
PlaceboDrug
Placebo, 1 dose every 12 hours x 4 doses
| Study group | Role | What they receive |
|---|---|---|
| PP4001 50 mg | Experimental | Not described Receives: Drug: PP4001 |
| PP4001 100 mg | Experimental | Not described Receives: Drug: PP4001 |
| PP4001 200 mg | Experimental | Not described Receives: Drug: PP4001 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the efficacy of PP4001 for the relief of burning during urination as measured by the subject's self-reported score at the time of urination in women with uUTI in comparison to placebo.
Measured: Assessed at each urination from the time of randomization to 48 hours post first dose.
Secondary outcomes (9)
Change from baseline in the physical exam evaluation at the End of Study visit
Body systems evaluated will include:
- General appearance
- Skin
- HEENT (Head, Ears, Eyes, Nose, Throat)
- Spine/Neck/Thyroid
- Respiratory
- Cardiovascular
- Abdomen
- Nervous System
- Musculoskeletal
Measured: The End of Study Visit is 48 - 100 hours post first dose. SAEs will be followed up to 30 days beyond the End of Study Visit.
To assess the efficacy of PP4001 for the relief of pain as measured by the subject's self-reported score at the time of urination.
Measured: Assessed at each urination from the time of randomization through 48 hours post first dose.
To assess the efficacy of PP4001 for reduction in urination frequency as measured by the subject's self-reported void diary.
Measured: Assessed at each urination from the time of randomization through 48 hours post first dose.
To evaluate the duration of therapeutic response to PP4001 50 mg, 100 mg and 200 mg.
Measured: Efficacy measures assessed in 2-hour windows after each dose.
To assess global assessment of uUTI symptom severity and change over time as measured by the subject-reported global assessment diaries.
Measured: Assessed at each urination from the time of randomization through 48 hours post first dose.
Change from baseline in vital signs at the End of Study visit
Vital sign measures will include systolic and diastolic blood pressure, pulse, respiratory rate, and temperature.
Measured: The End of Study Visit is 48 - 100 hours post first dose. SAEs will be followed up to 30 days after the End of Study Visit.
Change from baseline in ECG at the End of Study visit
ECG parameters to be reported in this study include heart rate, and interval parameters of RR, PR, QRS, QT, and QTc.
Measured: The End of Study Visit is 48 - 100 hours post first dose. SAEs will be followed up to 30 days beyond the End of Study Visit.
Change from baseline in laboratory evaluations at the End of Study visit
The following laboratory assessments will be performed: venous blood and urine samples for clinical laboratory testing, including hematology, serum chemistry, urinalysis, and urine culture.
Measured: The End of Study Visit is 48 - 100 hours post first dose. SAEs will be followed up to 30 days beyond the End of Study Visit.
Frequency, severity and relationship to study medication of treatment emergent adverse events
Frequency of treatment emergent AEs will be calculated for each body system, by preferred term, by treatment and by period for the number of subjects reporting the event for the safety population. The severity of the AEs and the relationship to study medication will be summarized for each body system and preferred term. Withdrawals due to AEs will be summarized for each body system and preferred term.
Measured: From first dose through the End of Study Visit (48 - 100 hours post first dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2011 (estimated)
- Study startJul 2011
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 261 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pinnacle Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Suma Krishnan, Study director, Pinnacle Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01406587
- Sponsor's protocol ID
- PP4001.301
- Status last verified
- Oct 2011
- First submitted
- 26 Jul 2011
- Last updated
- 19 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01406587
- Acronym / sponsor ID
- PP4001.301
- Conditions
- Urinary Tract Infection
- Keywords
- Burning, Dysuria, Frequency, Pain, Uncomplicated Urinary Tract Infection, Uncomplicated UTI, Urinary Tract Infection, UTI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 261 participants (actual)
- Lead sponsor
- Pinnacle Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 1 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PP4001 50 mg | Experimental | Drug: PP4001 |
| PP4001 100 mg | Experimental | Drug: PP4001 |
| PP4001 200 mg | Experimental | Drug: PP4001 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (23 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PP400150 mg, 1 dose every 12 hours x 4 doses | Drug | PP4001 50 mg |
| PP4001100 mg, 1 dose every 12 hours x 4 doses | Drug | PP4001 100 mg |
| PP4001200 mg, 1 dose every 12 hours x 4 doses | Drug | PP4001 200 mg |
| PlaceboPlacebo, 1 dose every 12 hours x 4 doses | Drug | Placebo |
Primary outcome
To assess the efficacy of PP4001 for the relief of burning during urination as measured by the subject's self-reported score at the time of urination in women with uUTI in comparison to placebo.
Time frame: Assessed at each urination from the time of randomization to 48 hours post first dose.
9 secondary outcomes
Change from baseline in the physical exam evaluation at the End of Study visit
Time frame: The End of Study Visit is 48 - 100 hours post first dose. SAEs will be followed up to 30 days beyond the End of Study Visit.
To assess the efficacy of PP4001 for the relief of pain as measured by the subject's self-reported score at the time of urination.
Time frame: Assessed at each urination from the time of randomization through 48 hours post first dose.
To assess the efficacy of PP4001 for reduction in urination frequency as measured by the subject's self-reported void diary.
Time frame: Assessed at each urination from the time of randomization through 48 hours post first dose.
To evaluate the duration of therapeutic response to PP4001 50 mg, 100 mg and 200 mg.
Time frame: Efficacy measures assessed in 2-hour windows after each dose.
To assess global assessment of uUTI symptom severity and change over time as measured by the subject-reported global assessment diaries.
Time frame: Assessed at each urination from the time of randomization through 48 hours post first dose.
Change from baseline in vital signs at the End of Study visit
Time frame: The End of Study Visit is 48 - 100 hours post first dose. SAEs will be followed up to 30 days after the End of Study Visit.
Change from baseline in ECG at the End of Study visit
Time frame: The End of Study Visit is 48 - 100 hours post first dose. SAEs will be followed up to 30 days beyond the End of Study Visit.
Change from baseline in laboratory evaluations at the End of Study visit
Time frame: The End of Study Visit is 48 - 100 hours post first dose. SAEs will be followed up to 30 days beyond the End of Study Visit.
Frequency, severity and relationship to study medication of treatment emergent adverse events
Time frame: From first dose through the End of Study Visit (48 - 100 hours post first dose)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suma Krishnan study director
Pinnacle Pharmaceuticals
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PP4001 in people with Urinary Tract Infection, run by Pinnacle Pharmaceuticals, Inc. at 25 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the efficacy of PP4001 for the relief of burning during urination as measured by the subject's self-reported score at the time of urination in women with uUTI in comparison to placebo. (time frame: Assessed at each urination from the time of randomization to 48 hours post first dose.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2011.