CystitisPhase 1UTINCT00801021
Treatment and/or Prevention of Urinary Tract Infections
A Phase 1 study testing Frio Mouth Rinse in people with Cystitis and Urinary Tract Infections, run by Biomedical Development Corporation at 1 site in United States.
Trial summary
The purpose of the study is to determine the effect of an investigational oral rinse in reducing uropathogens and treating uncomplicated urinary tract infections. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cystitis, Urinary Tract Infections
- What is being tested?
- Frio Mouth Rinse
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Jun 2009
- Phase
- Phase 1
- 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
- Non-pregnant adult females;
- 18 years of age or older;
- Clinical signs with one or more symptoms of a UTI (e.g., dysuria, frequency, urgency, suprapubic pain) with onset of symptoms < 72 hours prior to study entry;
- One positive dipstick urine test positive either for leukocyte esterase or nitrates or have a urinalysis with > 5 wbc/hpf.
- A pre-treatment clean-catch midstream urine culture with ≥ 104 CFU/mL of a bacterial organism
Who cannot join
- Males;
- Women who are pregnant, nursing, or not using a medically accepted, effective method of birth control;
- Three or more episodes of acute uncomplicated UTI in the past 12 months;
- Known structural abnormality that would predispose the participant to reflux or urinary retention;
- Patients with evidence of factors predisposing to the development of urinary tract infections, including calculi, stricture, primary renal disease (e.g., polycystic renal disease), or neurogenic bladder;
- Patients with significant impaired immunity secondary to chemotherapy, oral corticosteroids, or HIV;
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- Patients with onset of symptoms > 72 hours prior to entry;
- Patients with a temperature ≥ 100°F, flank pain, chills, or any other manifestations suggestive of upper urinary tract infection;
- Patients with purported hypersensitivity to iodine;
- Patients with history of thyroid disease;
- Patients who received treatment with other antimicrobials within 48 hours prior to entry;
- Any significant medical or psychiatric condition that would render examination difficult or invalid or prevent the subject from active study participation; inability to use an oral rinse;
- Use of concomitant medication that, in the opinion of the Study Directors, might interfere with the outcome of the study.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to determine the effect of an investigational oral rinse in reducing uropathogens and treating uncomplicated urinary tract infections.
Read the detailed description
A 7-day treatment with a 28-day follow up has been designed as a "before and after" assessment of the clinical signs and symptoms of an uncomplicated urinary tract infection and the reduction/eradication of urinary pathogens. Enrollment is targeted to achieving 20 evaluable subjects by the end of the study. After enrolling in the trial at Day 0 (first day of dosing), participants will report back to the study site at Days 3, 7, and 28. At Day 3 or any time thereafter, worsening of symptoms and/or increases in quantitative bacteria counts will result in removal from the trial and prescription of a rescue medication, which will be selected based on microbial susceptibility testing.
- Conditions
- Cystitis, Urinary Tract Infections
- Being tested
- Frio Mouth Rinse
- Keywords
- Cystitis, Urinary Tract Infections
- Medical subject headings
- Cystitis, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frio Mouth RinseDrug
Also called Prescription Mouth Rinse
Rinse with 15ml twice daily then expectorate
| Study group | Role | What they receive |
|---|---|---|
| Frio Oral Rinse | Experimental | Prescription Mouth Rinse Receives: Drug: Frio Mouth Rinse |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy endpoint is the reduction of the baseline pathogen at the Days 7 to 10 "Test of Cure" visit.
Measured: 7 to 10 Days
Secondary outcomes (1)
The secondary efficacy endpoint of microbiological evaluation classified into four categories (i.e., Eradication, Persistence, Superinfection, and New Infection)
Measured: 28-35 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CystitisStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biomedical Development Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Baylor College of Medicine
- Investigators
- Barbara W. Trautner, M.D., Ph.D., Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00801021
- Sponsor's protocol ID
- H-23281
- Other IDs
- 1R41DK082089-01
- Acronym
- UTI
- Status last verified
- Nov 2009
- First submitted
- 2 Dec 2008
- Last updated
- 8 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment and/or Prevention of Urinary Tract Infections
- ClinicalTrials.gov ID
- NCT00801021
- Acronym / sponsor ID
- UTI / H-23281
- Conditions
- Cystitis, Urinary Tract Infections
- Keywords
- Cystitis, Urinary Tract Infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Biomedical Development CorporationIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Baylor College of Medicine
- Study start
- Dec 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 3 Dec 2008 (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 purpose of the study is to determine the effect of an investigational oral rinse in reducing uropathogens and treating uncomplicated urinary tract infections.
Detailed description
A 7-day treatment with a 28-day follow up has been designed as a "before and after" assessment of the clinical signs and symptoms of an uncomplicated urinary tract infection and the reduction/eradication of urinary pathogens. Enrollment is targeted to achieving 20 evaluable subjects by the end of the study. After enrolling in the trial at Day 0 (first day of dosing), participants will report back to the study site at Days 3, 7, and 28. At Day 3 or any time thereafter, worsening of symptoms and/or increases in quantitative bacteria counts will result in removal from the trial and prescription of a rescue medication, which will be selected based on microbial susceptibility testing.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Frio Oral Rinse | Experimental | Drug: Frio Mouth RinsePrescription Mouth Rinse |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Non-pregnant adult females;
- 18 years of age or older;
- Clinical signs with one or more symptoms of a UTI (e.g., dysuria, frequency, urgency, suprapubic pain) with onset of symptoms < 72 hours prior to study entry;
- One positive dipstick urine test positive either for leukocyte esterase or nitrates or have a urinalysis with > 5 wbc/hpf.
- A pre-treatment clean-catch midstream urine culture with ≥ 104 CFU/mL of a bacterial organism
Key exclusion criteria (13 listed)
- Males;
- Women who are pregnant, nursing, or not using a medically accepted, effective method of birth control;
- Three or more episodes of acute uncomplicated UTI in the past 12 months;
- Known structural abnormality that would predispose the participant to reflux or urinary retention;
- Patients with evidence of factors predisposing to the development of urinary tract infections, including calculi, stricture, primary renal disease (e.g., polycystic renal disease), or neurogenic bladder;
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 |
|---|---|---|
| Frio Mouth RinseAlso: Prescription Mouth RinseRinse with 15ml twice daily then expectorate | Drug | Frio Oral Rinse |
Primary outcome
The primary efficacy endpoint is the reduction of the baseline pathogen at the Days 7 to 10 "Test of Cure" visit.
Time frame: 7 to 10 Days
1 secondary outcome
The secondary efficacy endpoint of microbiological evaluation classified into four categories (i.e., Eradication, Persistence, Superinfection, and New Infection)
Time frame: 28-35 Days
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 8 Mar 2010.
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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.
Barbara W. Trautner, M.D., Ph.D. principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Frio Mouth Rinse in people with Cystitis and Urinary Tract Infections, run by Biomedical Development Corporation 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 5 inclusion and 13 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 8 Mar 2010. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The primary efficacy endpoint is the reduction of the baseline pathogen at the Days 7 to 10 "Test of Cure" visit. (time frame: 7 to 10 Days). 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 8 Mar 2010.