Trial Outcomes & Findings for SMP-986 Phase 2 Proof of Concept in Patients With Overactive Bladder Syndrome (OABS) (NCT NCT00409539)
NCT ID: NCT00409539
Last Updated: 2014-12-10
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
550 participants
Primary outcome timeframe
8 Weeks
Results posted on
2014-12-10
Participant Flow
550 subjects were enrolled into the 2 week placebo run-in phase prior to randomization.
Participant milestones
| Measure |
Placebo
Placebo run-in phase. 2 week duration.
Placebo: Placebo, 2 week duration.
|
20mg Dose of SMP-986
20mg dose of SMP-986 to be taken once daily for 8 week duration.
SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks
|
40mg Dose of SMP-986
40mg dose of SMP-986 to be taken for 8 week duration.
SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks
|
80mg Dose of SMP-986
80mg dose of SMP-986 to be taken for 8 week duration.
SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks
|
120mg Dose of SMP-986
120mg dose of SMP-986 to be taken for 8 week duration.
SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
111
|
111
|
109
|
109
|
110
|
|
Overall Study
COMPLETED
|
100
|
100
|
95
|
97
|
85
|
|
Overall Study
NOT COMPLETED
|
11
|
11
|
14
|
12
|
25
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
SMP-986 Phase 2 Proof of Concept in Patients With Overactive Bladder Syndrome (OABS)
Baseline characteristics by cohort
| Measure |
Placebo
n=111 Participants
Placebo run-in phase. 2 week duration.
Placebo: Placebo, 2 week duration.
|
20mg Dose of SMP-986
n=111 Participants
20mg dose of SMP-986 to be taken once daily for 8 week duration.
SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks
|
40mg Dose of SMP-986
n=109 Participants
40mg dose of SMP-986 to be taken for 8 week duration.
SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks
|
80mg Dose of SMP-986
n=109 Participants
80mg dose of SMP-986 to be taken for 8 week duration.
SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks
|
120mg Dose of SMP-986
n=110 Participants
120mg dose of SMP-986 to be taken for 8 week duration.
SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks
|
Total
n=550 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
61.0 years
STANDARD_DEVIATION 11.15 • n=5 Participants
|
62.0 years
STANDARD_DEVIATION 9.60 • n=7 Participants
|
61.5 years
STANDARD_DEVIATION 9.93 • n=5 Participants
|
61.6 years
STANDARD_DEVIATION 9.04 • n=4 Participants
|
61.1 years
STANDARD_DEVIATION 10.08 • n=21 Participants
|
61.4 years
STANDARD_DEVIATION 9.96 • n=8 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
64 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
63 Participants
n=4 Participants
|
65 Participants
n=21 Participants
|
321 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
47 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
45 Participants
n=21 Participants
|
229 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
96 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
93 Participants
n=4 Participants
|
95 Participants
n=21 Participants
|
465 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
85 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
14 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
107 Participants
n=5 Participants
|
108 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
106 Participants
n=4 Participants
|
103 Participants
n=21 Participants
|
531 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=5 Participants
|
23 participants
n=7 Participants
|
14 participants
n=5 Participants
|
15 participants
n=4 Participants
|
25 participants
n=21 Participants
|
103 participants
n=8 Participants
|
|
Region of Enrollment
Poland
|
31 participants
n=5 Participants
|
27 participants
n=7 Participants
|
32 participants
n=5 Participants
|
30 participants
n=4 Participants
|
30 participants
n=21 Participants
|
150 participants
n=8 Participants
|
|
Region of Enrollment
Germany
|
29 participants
n=5 Participants
|
35 participants
n=7 Participants
|
40 participants
n=5 Participants
|
39 participants
n=4 Participants
|
30 participants
n=21 Participants
|
173 participants
n=8 Participants
|
|
Region of Enrollment
Estonia
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
2 participants
n=5 Participants
|
6 participants
n=4 Participants
|
6 participants
n=21 Participants
|
23 participants
n=8 Participants
|
|
Region of Enrollment
France
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
1 participants
n=21 Participants
|
4 participants
n=8 Participants
|
|
Region of Enrollment
Latvia
|
7 participants
n=5 Participants
|
8 participants
n=7 Participants
|
6 participants
n=5 Participants
|
7 participants
n=4 Participants
|
10 participants
n=21 Participants
|
38 participants
n=8 Participants
|
|
Region of Enrollment
Lithuania
|
11 participants
n=5 Participants
|
5 participants
n=7 Participants
|
13 participants
n=5 Participants
|
7 participants
n=4 Participants
|
3 participants
n=21 Participants
|
39 participants
n=8 Participants
|
|
Region of Enrollment
Spain
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
5 participants
n=21 Participants
|
12 participants
n=8 Participants
|
|
Region of Enrollment
United Kingdom
|
0 participants
n=5 Participants
|
4 participants
n=7 Participants
|
1 participants
n=5 Participants
|
3 participants
n=4 Participants
|
0 participants
n=21 Participants
|
8 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 8 WeeksOutcome measures
| Measure |
Placebo
n=111 Participants
Placebo run-in phase. 2 week duration.
Placebo: Placebo, 2 week duration.
|
20mg Dose of SMP-986
n=111 Participants
20mg dose of SMP-986 to be taken once daily for 8 week duration.
SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks
|
40mg Dose of SMP-986
n=109 Participants
40mg dose of SMP-986 to be taken for 8 week duration.
SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks
|
80mg Dose of SMP-986
n=109 Participants
80mg dose of SMP-986 to be taken for 8 week duration.
SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks
|
120mg Dose of SMP-986
n=110 Participants
120mg dose of SMP-986 to be taken for 8 week duration.
SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks
|
|---|---|---|---|---|---|
|
Change From Baseline to Week 8 in the Number of Voids/24 Hours
|
-1.06 voids/24 hrs.
Standard Error 2.223
|
-1.44 voids/24 hrs.
Standard Error 2.402
|
-1.78 voids/24 hrs.
Standard Error 2.376
|
-2.41 voids/24 hrs.
Standard Error 2.383
|
-1.92 voids/24 hrs.
Standard Error 2.145
|
SECONDARY outcome
Timeframe: 8 WeeksTreatment emergent adverse event summary
Outcome measures
| Measure |
Placebo
n=111 Participants
Placebo run-in phase. 2 week duration.
Placebo: Placebo, 2 week duration.
|
20mg Dose of SMP-986
n=111 Participants
20mg dose of SMP-986 to be taken once daily for 8 week duration.
SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks
|
40mg Dose of SMP-986
n=109 Participants
40mg dose of SMP-986 to be taken for 8 week duration.
SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks
|
80mg Dose of SMP-986
n=109 Participants
80mg dose of SMP-986 to be taken for 8 week duration.
SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks
|
120mg Dose of SMP-986
n=110 Participants
120mg dose of SMP-986 to be taken for 8 week duration.
SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks
|
|---|---|---|---|---|---|
|
To Assess the Safety and Tolerability of 20, 40, 80 and 120 mg SMP 986 (o.d) Following 8-weeks of Treatment in Patients With Over Active Bladder Syndrome
|
61 participants
|
62 participants
|
61 participants
|
87 participants
|
90 participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 39 other events
Deaths: 0 deaths
20mg Dose of SMP-986
Serious events: 1 serious events
Other events: 40 other events
Deaths: 0 deaths
40mg Dose of SMP-986
Serious events: 1 serious events
Other events: 50 other events
Deaths: 0 deaths
80mg Dose of SMP-986
Serious events: 0 serious events
Other events: 78 other events
Deaths: 0 deaths
120mg Dose of SMP-986
Serious events: 3 serious events
Other events: 81 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=111 participants at risk
Placebo run-in phase. 2 week duration.
Placebo: Placebo, 2 week duration.
|
20mg Dose of SMP-986
n=111 participants at risk
20mg dose of SMP-986 to be taken once daily for 8 week duration.
SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks
|
40mg Dose of SMP-986
n=109 participants at risk
40mg dose of SMP-986 to be taken for 8 week duration.
SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks
|
80mg Dose of SMP-986
n=109 participants at risk
80mg dose of SMP-986 to be taken for 8 week duration.
SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks
|
120mg Dose of SMP-986
n=110 participants at risk
120mg dose of SMP-986 to be taken for 8 week duration.
SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks
|
|---|---|---|---|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/111 • 8 Weeks
|
0.00%
0/111 • 8 Weeks
|
0.92%
1/109 • Number of events 1 • 8 Weeks
|
0.00%
0/109 • 8 Weeks
|
0.00%
0/110 • 8 Weeks
|
|
Nervous system disorders
Loss of Conciousness
|
0.00%
0/111 • 8 Weeks
|
0.00%
0/111 • 8 Weeks
|
0.00%
0/109 • 8 Weeks
|
0.00%
0/109 • 8 Weeks
|
0.91%
1/110 • Number of events 1 • 8 Weeks
|
|
Nervous system disorders
Sciatica
|
0.00%
0/111 • 8 Weeks
|
0.90%
1/111 • Number of events 1 • 8 Weeks
|
0.00%
0/109 • 8 Weeks
|
0.00%
0/109 • 8 Weeks
|
0.91%
1/110 • Number of events 1 • 8 Weeks
|
|
Nervous system disorders
Syncope
|
0.00%
0/111 • 8 Weeks
|
0.00%
0/111 • 8 Weeks
|
0.00%
0/109 • 8 Weeks
|
0.00%
0/109 • 8 Weeks
|
0.91%
1/110 • Number of events 1 • 8 Weeks
|
|
Vascular disorders
Hypotension
|
0.00%
0/111 • 8 Weeks
|
0.00%
0/111 • 8 Weeks
|
0.00%
0/109 • 8 Weeks
|
0.00%
0/109 • 8 Weeks
|
0.91%
1/110 • Number of events 1 • 8 Weeks
|
Other adverse events
| Measure |
Placebo
n=111 participants at risk
Placebo run-in phase. 2 week duration.
Placebo: Placebo, 2 week duration.
|
20mg Dose of SMP-986
n=111 participants at risk
20mg dose of SMP-986 to be taken once daily for 8 week duration.
SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks
|
40mg Dose of SMP-986
n=109 participants at risk
40mg dose of SMP-986 to be taken for 8 week duration.
SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks
|
80mg Dose of SMP-986
n=109 participants at risk
80mg dose of SMP-986 to be taken for 8 week duration.
SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks
|
120mg Dose of SMP-986
n=110 participants at risk
120mg dose of SMP-986 to be taken for 8 week duration.
SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks
|
|---|---|---|---|---|---|
|
Eye disorders
Vision Blurred
|
0.00%
0/111 • 8 Weeks
|
0.90%
1/111 • Number of events 1 • 8 Weeks
|
1.8%
2/109 • Number of events 2 • 8 Weeks
|
6.4%
7/109 • Number of events 7 • 8 Weeks
|
4.5%
5/110 • Number of events 5 • 8 Weeks
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
1.8%
2/111 • Number of events 2 • 8 Weeks
|
5.4%
6/111 • Number of events 6 • 8 Weeks
|
1.8%
2/109 • Number of events 2 • 8 Weeks
|
2.8%
3/109 • Number of events 3 • 8 Weeks
|
2.7%
3/110 • Number of events 5 • 8 Weeks
|
|
Gastrointestinal disorders
Constipation
|
3.6%
4/111 • Number of events 4 • 8 Weeks
|
0.90%
1/111 • Number of events 1 • 8 Weeks
|
0.92%
1/109 • Number of events 1 • 8 Weeks
|
7.3%
8/109 • Number of events 8 • 8 Weeks
|
9.1%
10/110 • Number of events 10 • 8 Weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
0.90%
1/111 • Number of events 1 • 8 Weeks
|
1.8%
2/111 • Number of events 2 • 8 Weeks
|
1.8%
2/109 • Number of events 2 • 8 Weeks
|
3.7%
4/109 • Number of events 4 • 8 Weeks
|
0.91%
1/110 • Number of events 1 • 8 Weeks
|
|
Gastrointestinal disorders
Dry Mouth
|
11.7%
13/111 • Number of events 13 • 8 Weeks
|
19.8%
22/111 • Number of events 25 • 8 Weeks
|
32.1%
35/109 • Number of events 39 • 8 Weeks
|
58.7%
64/109 • Number of events 70 • 8 Weeks
|
67.3%
74/110 • Number of events 80 • 8 Weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
0.90%
1/111 • Number of events 1 • 8 Weeks
|
0.00%
0/111 • 8 Weeks
|
4.6%
5/109 • Number of events 6 • 8 Weeks
|
5.5%
6/109 • Number of events 6 • 8 Weeks
|
2.7%
3/110 • Number of events 4 • 8 Weeks
|
|
Gastrointestinal disorders
Nausea
|
0.90%
1/111 • Number of events 1 • 8 Weeks
|
2.7%
3/111 • Number of events 3 • 8 Weeks
|
1.8%
2/109 • Number of events 2 • 8 Weeks
|
1.8%
2/109 • Number of events 2 • 8 Weeks
|
3.6%
4/110 • Number of events 4 • 8 Weeks
|
|
Infections and infestations
Bronchitis
|
1.8%
2/111 • Number of events 2 • 8 Weeks
|
1.8%
2/111 • Number of events 2 • 8 Weeks
|
0.92%
1/109 • Number of events 1 • 8 Weeks
|
3.7%
4/109 • Number of events 4 • 8 Weeks
|
1.8%
2/110 • Number of events 2 • 8 Weeks
|
|
Infections and infestations
Nasopharyngitis
|
6.3%
7/111 • Number of events 7 • 8 Weeks
|
3.6%
4/111 • Number of events 4 • 8 Weeks
|
3.7%
4/109 • Number of events 4 • 8 Weeks
|
3.7%
4/109 • Number of events 4 • 8 Weeks
|
3.6%
4/110 • Number of events 4 • 8 Weeks
|
|
Infections and infestations
Urinary Tract Infection
|
5.4%
6/111 • Number of events 6 • 8 Weeks
|
2.7%
3/111 • Number of events 3 • 8 Weeks
|
2.8%
3/109 • Number of events 3 • 8 Weeks
|
5.5%
6/109 • Number of events 6 • 8 Weeks
|
2.7%
3/110 • Number of events 6 • 8 Weeks
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.90%
1/111 • Number of events 1 • 8 Weeks
|
1.8%
2/111 • Number of events 2 • 8 Weeks
|
4.6%
5/109 • Number of events 22 • 8 Weeks
|
2.8%
3/109 • Number of events 3 • 8 Weeks
|
0.91%
1/110 • Number of events 1 • 8 Weeks
|
|
Nervous system disorders
Headache
|
8.1%
9/111 • Number of events 12 • 8 Weeks
|
5.4%
6/111 • Number of events 9 • 8 Weeks
|
4.6%
5/109 • Number of events 7 • 8 Weeks
|
9.2%
10/109 • Number of events 12 • 8 Weeks
|
6.4%
7/110 • Number of events 13 • 8 Weeks
|
Additional Information
Medical Director, Urology
Sunovion
Phone: 1-866-503-6351
Results disclosure agreements
- Principal investigator is a sponsor employee In addition to the \<60-180 day restriction above, since this is a multicenter study, 1st publication of study results shall be made with other participating study sites as a multicenter publication; provided, if a multicenter publication is not forthcoming within 24 months following completion of study at all sites, the PI shall be free to publish.
- Publication restrictions are in place
Restriction type: OTHER