Trial Outcomes & Findings for Sanctura Muscarinic Receptor Antagonist Resists Transport (SMART-II) Trial (NCT NCT01178827)
NCT ID: NCT01178827
Last Updated: 2016-02-26
Results Overview
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®.
COMPLETED
PHASE4
20 participants
Day 10 Post-Dose
2016-02-26
Participant Flow
Participant milestones
| Measure |
Sanctura XR®
Sanctura XR® (trospium chloride), 60mg once daily for 10 days
|
Oxybutynin IR
Oxybutynin IR (oxybutynin immediate release) 5 mg, three times daily for 2 days
|
Oxybutynin IR Placebo
Oxybutynin IR placebo three times daily for 2 days
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
10
|
4
|
|
Overall Study
COMPLETED
|
6
|
10
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sanctura Muscarinic Receptor Antagonist Resists Transport (SMART-II) Trial
Baseline characteristics by cohort
| Measure |
Sanctura XR®
n=6 Participants
Sanctura XR® (60mg) once daily for 10 days
|
Oxybutynin IR
n=10 Participants
Oxybutynin IR (5 mg) three times daily for 2 days
|
Oxybutynin IR Placebo
n=4 Participants
Oxybutynin IR placebo three times daily for 2 days
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
74.4 Years
STANDARD_DEVIATION 6.3 • n=99 Participants
|
68.3 Years
STANDARD_DEVIATION 6.1 • n=107 Participants
|
77.6 Years
STANDARD_DEVIATION 12.3 • n=206 Participants
|
72.0 Years
STANDARD_DEVIATION 8.2 • n=7 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Day 10 Post-DosePopulation: All patients who received Sanctura XR®
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®.
Outcome measures
| Measure |
Sanctura XR®
n=6 Participants
Sanctura XR® (60mg) once daily for 10 days
|
Oxybutynin IR
Oxybutynin IR (5 mg) three times daily for 2 days
|
Oxybutynin IR Placebo
Oxybutynin IR placebo three times daily for 2 days
|
|---|---|---|---|
|
Cerebral Spinal Fluid Levels of Sanctura XR® at Day 10 Post-dose
|
NA Nanograms (ng) per milliliter (mL)
Standard Deviation NA
Below level of detection
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 2 Post-DosePopulation: All patients who received Oxybutynin IR
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.
Outcome measures
| Measure |
Sanctura XR®
Sanctura XR® (60mg) once daily for 10 days
|
Oxybutynin IR
n=10 Participants
Oxybutynin IR (5 mg) three times daily for 2 days
|
Oxybutynin IR Placebo
Oxybutynin IR placebo three times daily for 2 days
|
|---|---|---|---|
|
Cerebral Spinal Fluid Levels of Oxybutynin and N-Desethyl-Oxybutynin at Day 2 Post-dose
Oxybutynin
|
—
|
0.0597 Nanograms (ng) per milliliter (mL)
Standard Deviation 0.0309
|
—
|
|
Cerebral Spinal Fluid Levels of Oxybutynin and N-Desethyl-Oxybutynin at Day 2 Post-dose
N-Desethyl-Oxybutynin
|
—
|
0.386 Nanograms (ng) per milliliter (mL)
Standard Deviation 0.235
|
—
|
SECONDARY outcome
Timeframe: Day 10 Post-DosePopulation: All patients who received of Sanctura XR®
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.
Outcome measures
| Measure |
Sanctura XR®
n=6 Participants
Sanctura XR® (60mg) once daily for 10 days
|
Oxybutynin IR
Oxybutynin IR (5 mg) three times daily for 2 days
|
Oxybutynin IR Placebo
Oxybutynin IR placebo three times daily for 2 days
|
|---|---|---|---|
|
Plasma Levels of Sanctura XR® at Day 10 Post-dose
|
1.47 Nanograms (ng) per milliliter (mL)
Standard Deviation 1.03
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 2 Post-DosePopulation: All patients who received of Oxybutynin IR
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.
Outcome measures
| Measure |
Sanctura XR®
Sanctura XR® (60mg) once daily for 10 days
|
Oxybutynin IR
n=10 Participants
Oxybutynin IR (5 mg) three times daily for 2 days
|
Oxybutynin IR Placebo
Oxybutynin IR placebo three times daily for 2 days
|
|---|---|---|---|
|
Plasma Levels of Oxybutynin and N-Desethyl-Oxybutynin at Day 2 Post-dose
Oxybutynin
|
—
|
8.80 Nanograms (ng) per milliliter (mL)
Standard Deviation 2.84
|
—
|
|
Plasma Levels of Oxybutynin and N-Desethyl-Oxybutynin at Day 2 Post-dose
N-Desethyl-Oxybutynin
|
—
|
47.0 Nanograms (ng) per milliliter (mL)
Standard Deviation 11.2
|
—
|
SECONDARY outcome
Timeframe: Baseline, 10 DaysPopulation: Per Protocol: All subjects who completed the study.
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.
Outcome measures
| Measure |
Sanctura XR®
n=6 Participants
Sanctura XR® (60mg) once daily for 10 days
|
Oxybutynin IR
n=10 Participants
Oxybutynin IR (5 mg) three times daily for 2 days
|
Oxybutynin IR Placebo
n=4 Participants
Oxybutynin IR placebo three times daily for 2 days
|
|---|---|---|---|
|
Change From Baseline in Total Recall Score as Measured by the Hopkins Verbal Learning Test-Revised (HVLT-R) up to Day 10
Baseline
|
22.5 Scores on a Scale
Standard Deviation 2.9
|
24.4 Scores on a Scale
Standard Deviation 3.3
|
24.0 Scores on a Scale
Standard Deviation 3.7
|
|
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 up to Day 10
|
-0.3 Scores on a Scale
Standard Deviation 3.3
|
-3.3 Scores on a Scale
Standard Deviation 5.4
|
-2.0 Scores on a Scale
Standard Deviation 4.8
|
SECONDARY outcome
Timeframe: Baseline, 10 DaysPopulation: Per Protocol: All subjects who completed the study.
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.
Outcome measures
| Measure |
Sanctura XR®
n=6 Participants
Sanctura XR® (60mg) once daily for 10 days
|
Oxybutynin IR
n=10 Participants
Oxybutynin IR (5 mg) three times daily for 2 days
|
Oxybutynin IR Placebo
n=4 Participants
Oxybutynin IR placebo three times daily for 2 days
|
|---|---|---|---|
|
Change From Baseline in Delayed Recall Score as Measured by the HVLT-R up to Day 10
Baseline
|
8.2 Scores on a Scale
Standard Deviation 1.2
|
9.4 Scores on a Scale
Standard Deviation 2.1
|
8.8 Scores on a Scale
Standard Deviation 2.1
|
|
Change From Baseline in Delayed Recall Score as Measured by the HVLT-R up to Day 10
Change from Baseline up to Day 10
|
-1.2 Scores on a Scale
Standard Deviation 1.5
|
-1.3 Scores on a Scale
Standard Deviation 1.6
|
-0.3 Scores on a Scale
Standard Deviation 3.7
|
SECONDARY outcome
Timeframe: Baseline, 10 DaysPopulation: Per Protocol: All subjects who completed the study.
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.
Outcome measures
| Measure |
Sanctura XR®
n=6 Participants
Sanctura XR® (60mg) once daily for 10 days
|
Oxybutynin IR
n=10 Participants
Oxybutynin IR (5 mg) three times daily for 2 days
|
Oxybutynin IR Placebo
n=4 Participants
Oxybutynin IR placebo three times daily for 2 days
|
|---|---|---|---|
|
Change From Baseline in Total Recall Score as Measured by the Brief Visuospatial Memory Test-Revised (BVMT-R) up to Day 10
Baseline
|
15.8 Scores on a Scale
Standard Deviation 6.6
|
20.3 Scores on a Scale
Standard Deviation 9.9
|
16.8 Scores on a Scale
Standard Deviation 11.3
|
|
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 up to Day 10
|
1.2 Scores on a Scale
Standard Deviation 7.4
|
-1.1 Scores on a Scale
Standard Deviation 5.3
|
0.0 Scores on a Scale
Standard Deviation 3.5
|
SECONDARY outcome
Timeframe: Baseline, 10 DaysPopulation: Per Protocol: All subjects who completed the study.
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.
Outcome measures
| Measure |
Sanctura XR®
n=6 Participants
Sanctura XR® (60mg) once daily for 10 days
|
Oxybutynin IR
n=10 Participants
Oxybutynin IR (5 mg) three times daily for 2 days
|
Oxybutynin IR Placebo
n=4 Participants
Oxybutynin IR placebo three times daily for 2 days
|
|---|---|---|---|
|
Change From Baseline in Delayed Recall Score as Measured by the BVMT-R up to Day 10
Baseline
|
6.0 Scores on a Scale
Standard Deviation 4.2
|
8.0 Scores on a Scale
Standard Deviation 3.6
|
4.5 Scores on a Scale
Standard Deviation 5.3
|
|
Change From Baseline in Delayed Recall Score as Measured by the BVMT-R up to Day 10
Change from Baseline up to Day 10
|
0.2 Scores on a Scale
Standard Deviation 3.4
|
-1.8 Scores on a Scale
Standard Deviation 3.5
|
2.3 Scores on a Scale
Standard Deviation 3.9
|
Adverse Events
Sanctura XR®
Oxybutynin IR
Oxybutynin IR Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sanctura XR®
n=6 participants at risk
Sanctura XR® (60mg) once daily for 10 days
|
Oxybutynin IR
n=10 participants at risk
Oxybutynin IR (5 mg) three times daily for 2 days
|
Oxybutynin IR Placebo
n=4 participants at risk
Oxybutynin IR placebo three times daily for 2 days
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/6
|
10.0%
1/10
|
0.00%
0/4
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/6
|
20.0%
2/10
|
0.00%
0/4
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/6
|
10.0%
1/10
|
0.00%
0/4
|
|
Gastrointestinal disorders
Nausea
|
33.3%
2/6
|
20.0%
2/10
|
0.00%
0/4
|
|
General disorders
Oedema Peripheral
|
0.00%
0/6
|
10.0%
1/10
|
0.00%
0/4
|
|
Nervous system disorders
Headache
|
83.3%
5/6
|
50.0%
5/10
|
50.0%
2/4
|
|
Nervous system disorders
Lethargy
|
16.7%
1/6
|
0.00%
0/10
|
0.00%
0/4
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/6
|
10.0%
1/10
|
0.00%
0/4
|
|
Ear and labyrinth disorders
Tinnitus
|
16.7%
1/6
|
0.00%
0/10
|
0.00%
0/4
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
1/6
|
0.00%
0/10
|
0.00%
0/4
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6
|
10.0%
1/10
|
0.00%
0/4
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/6
|
10.0%
1/10
|
0.00%
0/4
|
|
General disorders
Application Site Pruritus
|
16.7%
1/6
|
0.00%
0/10
|
0.00%
0/4
|
|
Investigations
Body Temperature Increased
|
0.00%
0/6
|
10.0%
1/10
|
0.00%
0/4
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
1/6
|
0.00%
0/10
|
0.00%
0/4
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
66.7%
4/6
|
30.0%
3/10
|
25.0%
1/4
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
16.7%
1/6
|
10.0%
1/10
|
25.0%
1/4
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Stiffness
|
16.7%
1/6
|
0.00%
0/10
|
0.00%
0/4
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/6
|
10.0%
1/10
|
0.00%
0/4
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
16.7%
1/6
|
40.0%
4/10
|
50.0%
2/4
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6
|
20.0%
2/10
|
0.00%
0/4
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6
|
10.0%
1/10
|
0.00%
0/4
|
|
Renal and urinary disorders
Micturition Urgency
|
0.00%
0/6
|
10.0%
1/10
|
0.00%
0/4
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Tract Congestion
|
16.7%
1/6
|
0.00%
0/10
|
0.00%
0/4
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER