PainPhase 3NCT01064024
Evaluate the Safety and Efficacy of Phenazopyridine Hydrochloride Tablets, USP 200 mg vs. Placebo
A Phase 3 study testing Phenazopyridine Hydrochloride in people with Pain and Urinary Tract Infections, run by Amneal Pharmaceuticals, LLC at 1 site in United States.
Trial summary
This study will evaluate the safety and efficacy of Phenazopyridine Hydrochloride Tablets, USP 200 mg as a short term analgesic treatment for the primary symptoms of pain or burning when passing urine 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
- Pain, Urinary Tract Infections
- What is being tested?
- Phenazopyridine Hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 233 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Dec 2010
- 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
- Diagnosis of uncomplicated urinary tract infection (uUTI)
- Must have one of the following uUTI diagnosis
- Cystitis
- Urethritis
- A Positive urine dipstick test showing nitrate or leukocyte esterase (LE)
- Negative pregnancy test (if applicable)
Show all 15Show fewer
- Must have one or both of the following symptoms of
- pain upon urination
- burning upon urination
- In addition, one of the following symptoms
- Not being able to empty bladder completely
- Pain or discomfort in lower abdomen, or pelvic areas
- Frequent urge to urinate
- Blood in urine
- None
Who cannot join
- Any diagnosis of a urinary tract or kidney disorder that is not a uUTI
- A diagnosis of Pyelonephritis (kidney infections when lower uUTI spreads to the upper tract)
- Women with a history of prior use of phenazopyridine hydrochloride
- Women who have taken any systemic anti-infectives within seven days of study participation
- Women with a history of G-6-PD deficiency or hemolytic anemia
- Women who have a known history of anatomical genitourinary (GU) anomalies or GU surgery within the past 6 months
Show all 16Show fewer
- Women of child bearing age who do not consent to a pregnancy test
- Women who are lactating
- Chronic infection of the urinary tract requiring an intravenous pyelogram (IVP), ultrasound or cystoscopy
- Subjects with clinically significant abnormal results or finding on the screening physical examination, laboratory tests, vital signs or ECG.
- Subjects unable to comprehend the language of the informed consent and the self evaluation scales.
- Subjects with serious acute illness (e.g. pneumonia) or an untreated or unstable medical illness that would likely interfere with assessments of uUTI
- Subjects who have received an investigational medication as part of a drug trial 3 months prior to the baseline study visit
- Subjects with a history of severe drug allergy or hypersensitivity
- Subjects with a known sensitivity to Phenazopyridine, Hyoscyamine, Butabarbital and antibiotics.
- 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
1 site in 1 country.
United States1 site
Oxford Pharmaceutical Resources, Inc.
Totowa, New Jersey, 07512
About this study
Official title: A Double Blind, Randomized, Parallel Controlled Study to Evaluate the Safety and Efficacy of Phenazopyridine Hydrochloride Tablets, USP 200 mg vs. Placebo as a Urinary Analgesic for Short Term Treatment in Female Subjects Suffering From Pain or Burning When Passing Urine Associated With Uncomplicated Urinary Tract Infections (uUTI)
This study will evaluate the safety and efficacy of Phenazopyridine Hydrochloride Tablets, USP 200 mg as a short term analgesic treatment for the primary symptoms of pain or burning when passing urine associated with uncomplicated urinary tract infections (uUTI)
- Conditions
- Pain, Urinary Tract Infections
- Being tested
- Phenazopyridine Hydrochloride, Placebo
- Keywords
- uUTI, Pain or burning associated with Uncomplicated Urinary Tract Infections
- Medical subject headings
- Pain, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phenazopyridine HydrochlorideDrug
Also called Pyridium
Tablets, 200 mg, every 8 hours for 48 hours.
PlaceboDrug
Tablets, every 8 hours for 48 hours
| Study group | Role | What they receive |
|---|---|---|
| Phenazopyridine Hydrochloride Tablets, USP 200 mg | Active comparator | Not described Receives: Drug: Phenazopyridine Hydrochloride |
| Placebo | Placebo comparator | Matching placebo to the phenazopyridine hydrochloride tablets Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of subjects in each treatment group who demonstrate reduction in pain or burning when passing urine.
Measured: 24 hrs after first dose and 48 hrs after second dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2010 (estimated)
- Study startDec 2009
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- 233 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amneal Pharmaceuticals, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Oxford Pharmaceutical Resources, Inc., Sristek Clinical Research Solutions Limited, Biostudy Solutions, LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01064024
- Sponsor's protocol ID
- AM-PHN-001
- Status last verified
- Jan 2013
- First submitted
- 4 Feb 2010
- Last updated
- 29 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Randomized, Parallel Controlled Study to Evaluate the Safety and Efficacy of Phenazopyridine Hydrochloride Tablets, USP 200 mg vs. Placebo as a Urinary Analgesic for Short Term Treatment in Female Subjects Suffering From Pain or Burning When Passing Urine Associated With Uncomplicated Urinary Tract Infections (uUTI)
- ClinicalTrials.gov ID
- NCT01064024
- Acronym / sponsor ID
- AM-PHN-001
- Conditions
- Pain, Urinary Tract Infections
- Keywords
- uUTI, Pain or burning associated with Uncomplicated Urinary Tract Infections
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 233 participants (actual)
- Lead sponsor
- Amneal Pharmaceuticals, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Oxford Pharmaceutical Resources, Inc., Sristek Clinical Research Solutions Limited, Biostudy Solutions, LLC
- Study start
- Dec 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 8 Feb 2010 (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.
This study will evaluate the safety and efficacy of Phenazopyridine Hydrochloride Tablets, USP 200 mg as a short term analgesic treatment for the primary symptoms of pain or burning when passing urine associated with uncomplicated urinary tract infections (uUTI)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phenazopyridine Hydrochloride Tablets, USP 200 mg | Active comparator | Drug: Phenazopyridine Hydrochloride |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo to the phenazopyridine hydrochloride tablets |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Diagnosis of uncomplicated urinary tract infection (uUTI)
- Must have one of the following uUTI diagnosis
- Cystitis
- Urethritis
- A Positive urine dipstick test showing nitrate or leukocyte esterase (LE)
Key exclusion criteria (16 listed)
- Any diagnosis of a urinary tract or kidney disorder that is not a uUTI
- A diagnosis of Pyelonephritis (kidney infections when lower uUTI spreads to the upper tract)
- Women with a history of prior use of phenazopyridine hydrochloride
- Women who have taken any systemic anti-infectives within seven days of study participation
- Women with 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 |
|---|---|---|
| Phenazopyridine HydrochlorideAlso: PyridiumTablets, 200 mg, every 8 hours for 48 hours. | Drug | Phenazopyridine Hydrochloride Tablets, USP 200 mg |
| PlaceboTablets, every 8 hours for 48 hours | Drug | Placebo |
Primary outcome
proportion of subjects in each treatment group who demonstrate reduction in pain or burning when passing urine.
Time frame: 24 hrs after first dose and 48 hrs after second 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 29 Jan 2013.
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
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 in people with Pain and 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 15 inclusion and 16 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 29 Jan 2013. 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?
proportion of subjects in each treatment group who demonstrate reduction in pain or burning when passing urine. (time frame: 24 hrs after first dose and 48 hrs after second 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 29 Jan 2013.