Uncomplicated Urinary Tract InfectionsPhase 3NCT01650051
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)
A Phase 3 study testing Phenazopyridine Hydrochloride Tables, USP 200 mg in people with Uncomplicated Urinary Tract Infections, run by Amneal Pharmaceuticals, LLC at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Uncomplicated Urinary Tract Infections
- What is being tested?
- Phenazopyridine Hydrochloride Tables, USP 200 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 424 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Feb 2014
- Phase
- Phase 3
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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.
- Conditions
- Uncomplicated Urinary Tract Infections
- Being tested
- Placebo of Phenazopyridine Hydrochloride Tables, USP 200 mg, Phenazopyridine Hydrochloride Tables, USP 200 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo of Phenazopyridine Hydrochloride Tables, USP 200 mgDrug
Deep brown maroon colored, film coated round biconvex tablet debossed 'AN" obve '2' on one side and plain on the other side.
Phenazopyridine Hydrochloride Tables, USP 200 mgDrug
Deep brown maroon colored, film coated round biconvex tablet debossed 'AN" obve '2' on one side and plain on the other side.
| Study group | Role | What they receive |
|---|---|---|
| Placebo of Phenazopyridine Hydrochloride Tables, USP 200 mg | Placebo comparator | Not described Receives: Drug: Placebo of Phenazopyridine Hydrochloride Tables, USP 200 mg |
| Phenazopyridine Hydrochloride Tables, USP 200 mg | Experimental | Not described Receives: Drug: Phenazopyridine Hydrochloride Tables, USP 200 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-assessments
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.
Measured: Designated Intervals for 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2012 (estimated)
- Study startFeb 2012
- Primary completionFeb 2013
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uncomplicated Urinary Tract InfectionsStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 424 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amneal Pharmaceuticals, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Symbio, LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01650051
- Sponsor's protocol ID
- AM-PHN-004
- Status last verified
- Jun 2014
- First submitted
- 19 Jul 2012
- Last updated
- 26 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01650051
- Acronym / sponsor ID
- AM-PHN-004
- Conditions
- Uncomplicated Urinary Tract Infections
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 424 participants (actual)
- Lead sponsor
- Amneal Pharmaceuticals, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Symbio, LLC
- Study start
- Feb 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 26 Jul 2012 (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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo of Phenazopyridine Hydrochloride Tables, USP 200 mg | Placebo comparator | Drug: Placebo of Phenazopyridine Hydrochloride Tables, USP 200 mg |
| Phenazopyridine Hydrochloride Tables, USP 200 mg | Experimental | Drug: Phenazopyridine Hydrochloride Tables, USP 200 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
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 |
|---|---|---|
| Placebo of Phenazopyridine Hydrochloride Tables, USP 200 mgDeep brown maroon colored, film coated round biconvex tablet debossed 'AN" obve '2' on one side and plain on the other side. | Drug | Placebo of Phenazopyridine Hydrochloride Tables, USP 200 mg |
| Phenazopyridine Hydrochloride Tables, USP 200 mgDeep brown maroon colored, film coated round biconvex tablet debossed 'AN" obve '2' on one side and plain on the other side. | Drug | Phenazopyridine Hydrochloride Tables, USP 200 mg |
Primary outcome
Self-assessments
Time frame: Designated Intervals for 24 hours
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.
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 26 Jun 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Phenazopyridine Hydrochloride Tables, USP 200 mg in people with Uncomplicated Urinary Tract Infections, run by Amneal Pharmaceuticals, LLC at 1 site 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 8 inclusion and 17 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 26 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Self-assessments (time frame: Designated Intervals for 24 hours). 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 26 Jun 2014.