Urinary Catheter Blockage and EncrustationPhase 2NCT01243125
Study to Evaluate NVC-422 for Urinary Catheter Blockage and Encrustation
A Phase 2 study testing NVC-422, 0.2% and Sterile normal saline, 0.9% in people with Urinary Catheter Blockage and Encrustation, run by NovaBay Pharmaceuticals, Inc. at 8 sites in United States.
Trial summary
NVC-422 is a topical, non-antibiotic, fast-acting, broad-spectrum anti-microbial, which exhibits the potential to prevent the growth of urinary pathogens, including Proteus and others. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Catheter Blockage and Encrustation
- What is being tested?
- NVC-422, 0.2% and Sterile normal saline, 0.9%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 8 sitesUnited States
- Study dates
- Nov 2010to Aug 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Spinal Cord Injury (SCI) or other neurogenic bladder patient requiring a chronic indwelling urinary catheter with history of catheter blockage and/or encrustation
- Screening within 30 days of first treatment
Who cannot join
- Systemic antibiotics within 7 days of first treatment
- Investigational drug or device within 30 days of enrollment
- Current infection that requires treatment with systemic antibiotics
- Recent history of significant autonomic dysreflexia (requiring intervention or treatment)
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Carolinas Medical Center
Charlotte, North Carolina, 28203
Los Amigos Research and Education Institute (LAREI)
Downey, California, 90242
Integrity Medical Research
Mountlake Terrace, Washington, 98043
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
Specialists in Urology
Naples, Florida, 34102
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
McGuire Veterans Affairs Medical Center
Richmond, Virginia, 23249
Kessler Institute for Rehabilitation
West Orange, New Jersey, 07052
About this study
Official title: A Multicenter, Double-blind, Crossover Design, Pilot Study to Evaluate the Effect of NVC-422 Catheter Irrigation on Urinary Catheter Patency
NVC-422 is a topical, non-antibiotic, fast-acting, broad-spectrum anti-microbial, which exhibits the potential to prevent the growth of urinary pathogens, including Proteus and others.
The use of a catheter irrigation solution that can prevent biofilm formation and encrustation leading to blockage may keep the catheter patent longer, resulting in fewer catheter changes, potentially lower incidence of UTIs, and better patient quality of life.
Read more
The study population will include male and female spinal cord injury (SCI) and other neurogenic bladder patients with chronic indwelling transurethral urinary catheters who have a recent repeated history of urinary catheter encrustation and/or blockage.
Subjects will receive two treatment regimens: one treatment regimen with NVC-422 sterile irrigation solution and one treatment regimen with sterile saline irrigation solution. Each treatment regimen will consist of a total of 8 treatments, with a washout period between treatment regimens.
- Being tested
- NVC-422, 0.2%, Sterile normal saline, 0.9%
- Keywords
- Blockage, Encrustation, Catheter, Spinal Cord Injury, SCI
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NVC-422, 0.2%Drug
Also called N,N-dichloro-2,2-dimethyltaurine
0.2% NVC-422 (sterile), 25 ml instilled and retained in catheter for 15 min, 2x/day; 8 treatments administered over a 26 day period
Sterile normal saline, 0.9%Drug
Also called 0.9% Sodium chloride for injection, USP
Saline (sterile), 25 ml instilled and retained in catheter for 15 min, 2x/day; 8 treatments administered over a 26 day period
| Study group | Role | What they receive |
|---|---|---|
| NVC-422 | Experimental | Not described Receives: Drug: NVC-422, 0.2% |
| Saline | Placebo comparator | Not described Receives: Drug: Sterile normal saline, 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Catheter patency following treatment
Cross sectional area (percent of open area that is not encrusted) will be determined at pre-selected loci on the catheter
Measured: 26 days
Secondary outcomes (3)
Incidence of catheter blockage requiring early removal
Catheters removed prior to completion of treatment regimen will be assessed for each treatment group
Measured: 26 days
Assessment of biofilm of catheter
Qualitative and quantitative assessment of biofilm of catheter will be determined for all catheters removed
Measured: 26 days
Assessment of encrustation of catheter
Qualitative and quantitative assessment of encrustation of catheter will be determined for all catheters removed
Measured: 26 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionJul 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Catheter Blockage and EncrustationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- NovaBay Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kenneth D. Krantz, MD, PhD, Study director, NovaBay Pharmaceuticals / kkrantz@novabaypharma.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01243125
- Sponsor's protocol ID
- CL1001
- Status last verified
- Aug 2014
- First submitted
- 15 Nov 2010
- Last updated
- 7 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-blind, Crossover Design, Pilot Study to Evaluate the Effect of NVC-422 Catheter Irrigation on Urinary Catheter Patency
- ClinicalTrials.gov ID
- NCT01243125
- Acronym / sponsor ID
- CL1001
- Keywords
- Blockage, Encrustation, Catheter, Spinal Cord Injury, SCI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- NovaBay Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Jul 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 18 Nov 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.
NVC-422 is a topical, non-antibiotic, fast-acting, broad-spectrum anti-microbial, which exhibits the potential to prevent the growth of urinary pathogens, including Proteus and others.
The use of a catheter irrigation solution that can prevent biofilm formation and encrustation leading to blockage may keep the catheter patent longer, resulting in fewer catheter changes, potentially lower incidence of UTIs, and better patient quality of life.
The study population will include male and female spinal cord injury (SCI) and other neurogenic bladder patients with chronic indwelling transurethral urinary catheters who have a recent repeated history of urinary catheter encrustation and/or blockage.
Subjects will receive two treatment regimens: one treatment regimen with NVC-422 sterile irrigation solution and one treatment regimen with sterile saline irrigation solution. Each treatment regimen will consist of a total of 8 treatments, with a washout period between treatment regimens.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NVC-422 | Experimental | Drug: NVC-422, 0.2% |
| Saline | Placebo comparator | Drug: Sterile normal saline, 0.9% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Spinal Cord Injury (SCI) or other neurogenic bladder patient requiring a chronic indwelling urinary catheter with history of catheter blockage and/or encrustation
- Screening within 30 days of first treatment
Key exclusion criteria (4 listed)
- Systemic antibiotics within 7 days of first treatment
- Investigational drug or device within 30 days of enrollment
- Current infection that requires treatment with systemic antibiotics
- Recent history of significant autonomic dysreflexia (requiring intervention or treatment)
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 |
|---|---|---|
| NVC-422, 0.2%Also: N,N-dichloro-2,2-dimethyltaurine0.2% NVC-422 (sterile), 25 ml instilled and retained in catheter for 15 min, 2x/day; 8 treatments administered over a 26 day period | Drug | NVC-422 |
| Sterile normal saline, 0.9%Also: 0.9% Sodium chloride for injection, USPSaline (sterile), 25 ml instilled and retained in catheter for 15 min, 2x/day; 8 treatments administered over a 26 day period | Drug | Saline |
Primary outcome
Catheter patency following treatment
Time frame: 26 days
Cross sectional area (percent of open area that is not encrusted) will be determined at pre-selected loci on the catheter
3 secondary outcomes
Incidence of catheter blockage requiring early removal
Time frame: 26 days
Assessment of biofilm of catheter
Time frame: 26 days
Assessment of encrustation of catheter
Time frame: 26 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 7 Aug 2014.
Related trials for Urinary Catheter Blockage and Encrustation
Recruiting
Effectiveness of the NowCath Foley in Reducing Catheter-Associated UTIs and Blockages in Long-Term Indwelling Catheter Users (REDUCE)
Urinary Catheters, Urinary Catheterization
Recruiting
A Novel Ureteric Stent in Kidney Stone Patients and Oncology Patients Compared to a Conventional JJ Stent
Catheter Blockage, Oncology
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.
Kenneth D. Krantz, MD, PhD study director
NovaBay Pharmaceuticals / kkrantz@novabaypharma.com
8 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 NVC-422, 0.2% and Sterile normal saline, 0.9% in people with Urinary Catheter Blockage and Encrustation, run by NovaBay Pharmaceuticals, Inc. at 8 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 2 inclusion and 4 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 7 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
Catheter patency following treatment (time frame: 26 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 7 Aug 2014.