Overactive BladderPhase 4NCT01178827
Sanctura Muscarinic Receptor Antagonist Resists Transport (SMART-II) Trial
A Phase 4 study testing trospium chloride and oxybutynin IR in people with Overactive Bladder, run by Allergan at 1 site in United States.
Trial summary
This study will evaluate the cerebrospinal fluid levels of trospium chloride (Sanctura XR®) and oxybutynin immediate release (Oxybutynin IR) on memory performance in patients with overactive bladder and age associated memory impairment. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- trospium chloride and oxybutynin IR
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Mar 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient presents symptoms of overactive bladder
- Patient has age associated memory impairment
- No acute or unstable medical conditions
Who cannot join
- History of alcohol or substance abuse within 1 year prior to study
- Has donated in excess of 500mL of blood or plasma in the 30 days prior to study
- Has known bleeding disorder (hemophilia)
- Previous abdominal bypass surgery for obesity
Trial locations and contacts
1 site in 1 country.
About this study
This study will evaluate the cerebrospinal fluid levels of trospium chloride (Sanctura XR®) and oxybutynin immediate release (Oxybutynin IR) on memory performance in patients with overactive bladder and age associated memory impairment.
- Conditions
- Overactive Bladder
- Being tested
- trospium chloride, oxybutynin IR, oxybutynin IR placebo
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trospium chlorideDrug
Also called Sanctura XR®
trospium chloride (60mg) once daily for 10 days
oxybutynin IRDrug
oxybutynin IR (5 mg) three times daily for 2 days
oxybutynin IR placeboDrug
oxybutynin IR placebo three times daily for 2 days
| Study group | Role | What they receive |
|---|---|---|
| Sanctura XR® | Experimental | Sanctura XR® (trospium chloride), 60mg once daily for 10 days Receives: Drug: trospium chloride |
| Oxybutynin IR | Active comparator | Oxybutynin IR (oxybutynin immediate release), 5 mg three times daily for 2 days Receives: Drug: oxybutynin IR |
| Oxybutynin IR placebo | Placebo comparator | Oxybutynin IR placebo three times daily for 2 days Receives: Drug: oxybutynin IR placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral Spinal Fluid Levels of Sanctura XR® at Day 10 Post-dose
Cerebral spinal fluid levels of Sanctura XR® at Day 10 Post-dose. Cerebral spinal fluid is the fluid that surrounds the spinal cord and the inside of the brain. Samples were drawn from patients who received Sanctura XR®.
Measured: Day 10 Post-Dose
Cerebral Spinal Fluid Levels of Oxybutynin and N-Desethyl-Oxybutynin at Day 2 Post-dose
Cerebral spinal fluid levels of Oxybutynin and N-Desethyl-Oxybutynin (metabolite of Oxybutynin) at Day 2 Post-dose. Cerebral spinal fluid is the fluid that surrounds the spinal cord and the inside of the brain. Samples were drawn from patients who received Oxybutynin IR.
Measured: Day 2 Post-Dose
Secondary outcomes (6)
Plasma Levels of Sanctura XR® at Day 10 Post-dose
Plasma levels of Sanctura XR® at Day 10 post-dose. Plasma is the liquid component of the blood in which the blood cells are suspended. Plasma samples were collected from each patient and analyzed for the drug the patient received.
Measured: Day 10 Post-Dose
Plasma Levels of Oxybutynin and N-Desethyl-Oxybutynin at Day 2 Post-dose
Plasma levels of Oxybutynin and N-Desethyl-Oxybutynin (metabolite of Oxybutynin) at Day 2 post-dose. Plasma is the liquid component of the blood in which the blood cells are suspended. Plasma samples were collected from each patient and analyzed for the drug the patient received.
Measured: Day 2 Post-Dose
Change From Baseline in Total Recall Score as Measured by the Hopkins Verbal Learning Test-Revised (HVLT-R) up to Day 10
Change from Baseline in Total Recall Score as Measured by the HVLT-R up to Day 10. The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition. The total recall score was the sum of 3 'free recall' learning trials, and reflects the patient's ability to learn. The total score ranges from 0 (no memory) to 36 (best memory). A positive change from baseline indicates improved memory and a negative change from baseline indicates worsened memory.
Measured: Baseline, 10 Days
Change From Baseline in Delayed Recall Score as Measured by the HVLT-R up to Day 10
Change from Baseline in Delayed Recall Score as Measured by the HVLT-R up to Day 10. The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition. The total recall score was the sum of 3 'free recall' learning trials, and reflects the patient's ability to learn. The total score ranges from 0 (no memory) to 12 (best memory). A positive change from baseline indicates improved memory.
Measured: Baseline, 10 Days
Change From Baseline in Total Recall Score as Measured by the Brief Visuospatial Memory Test-Revised (BVMT-R) up to Day 10
Change from Baseline in total recall score as measured by the BVMT-R up to Day 10. The BVMT-R is an instrument used to measure visual learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition trial. The total recall score is the sum of 3 free recall learning trials, and reflects the patient's ability to learn. The total score ranges from 0 (no memory) to 36 (best memory). A positive change from baseline indicates improved memory.
Measured: Baseline, 10 Days
Change From Baseline in Delayed Recall Score as Measured by the BVMT-R up to Day 10
Change from Baseline in delayed recall score as measured by the BVMT-R up to Day 10. The BVMT-R is an instrument used to measure visual learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition trial. The total recall score is the sum of 3 free recall learning trials, and reflects the patient's ability to learn. The total score ranges from 0 (no memory) to 12 (best memory). A positive change from baseline indicates improved memory.
Measured: Baseline, 10 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Overactive BladderStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01178827
- Sponsor's protocol ID
- MA-SXR-09-005
- Status last verified
- Jan 2016
- First submitted
- 9 Aug 2010
- Last updated
- 26 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sanctura Muscarinic Receptor Antagonist Resists Transport (SMART-II) Trial
- ClinicalTrials.gov ID
- NCT01178827
- Acronym / sponsor ID
- MA-SXR-09-005
- Conditions
- Overactive Bladder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 10 Aug 2010 (estimated)
- Results
- Posted 16 Aug 2012
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 cerebrospinal fluid levels of trospium chloride (Sanctura XR®) and oxybutynin immediate release (Oxybutynin IR) on memory performance in patients with overactive bladder and age associated memory impairment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sanctura XR® | Experimental | Drug: trospium chlorideSanctura XR® (trospium chloride), 60mg once daily for 10 days |
| Oxybutynin IR | Active comparator | Drug: oxybutynin IROxybutynin IR (oxybutynin immediate release), 5 mg three times daily for 2 days |
| Oxybutynin IR placebo | Placebo comparator | Drug: oxybutynin IR placeboOxybutynin IR placebo three times daily for 2 days |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient presents symptoms of overactive bladder
- Patient has age associated memory impairment
- No acute or unstable medical conditions
Key exclusion criteria (4 listed)
- History of alcohol or substance abuse within 1 year prior to study
- Has donated in excess of 500mL of blood or plasma in the 30 days prior to study
- Has known bleeding disorder (hemophilia)
- Previous abdominal bypass surgery for obesity
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 |
|---|---|---|
| trospium chlorideAlso: Sanctura XR®trospium chloride (60mg) once daily for 10 days | Drug | Sanctura XR® |
| oxybutynin IRoxybutynin IR (5 mg) three times daily for 2 days | Drug | Oxybutynin IR |
| oxybutynin IR placebooxybutynin IR placebo three times daily for 2 days | Drug | Oxybutynin IR placebo |
Primary outcome
Cerebral Spinal Fluid Levels of Sanctura XR® at Day 10 Post-dose
Time frame: Day 10 Post-Dose
Cerebral spinal fluid levels of Sanctura XR® at Day 10 Post-dose. Cerebral spinal fluid is the fluid that surrounds the spinal cord and the inside of the brain. Samples were drawn from patients who received Sanctura XR®.
Cerebral Spinal Fluid Levels of Oxybutynin and N-Desethyl-Oxybutynin at Day 2 Post-dose
Time frame: Day 2 Post-Dose
Cerebral spinal fluid levels of Oxybutynin and N-Desethyl-Oxybutynin (metabolite of Oxybutynin) at Day 2 Post-dose. Cerebral spinal fluid is the fluid that surrounds the spinal cord and the inside of the brain. Samples were drawn from patients who received Oxybutynin IR.
6 secondary outcomes
Plasma Levels of Sanctura XR® at Day 10 Post-dose
Time frame: Day 10 Post-Dose
Plasma Levels of Oxybutynin and N-Desethyl-Oxybutynin at Day 2 Post-dose
Time frame: Day 2 Post-Dose
Change From Baseline in Total Recall Score as Measured by the Hopkins Verbal Learning Test-Revised (HVLT-R) up to Day 10
Time frame: Baseline, 10 Days
Change From Baseline in Delayed Recall Score as Measured by the HVLT-R up to Day 10
Time frame: Baseline, 10 Days
Change From Baseline in Total Recall Score as Measured by the Brief Visuospatial Memory Test-Revised (BVMT-R) up to Day 10
Time frame: Baseline, 10 Days
Change From Baseline in Delayed Recall Score as Measured by the BVMT-R up to Day 10
Time frame: Baseline, 10 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Medical Director study director
Allergan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing trospium chloride and oxybutynin IR in people with Overactive Bladder, run by Allergan 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 3 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 26 Feb 2016. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Cerebral Spinal Fluid Levels of Sanctura XR® at Day 10 Post-dose (time frame: Day 10 Post-Dose). The study lists 2 primary outcomes in all. 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 Feb 2016.