FindTrial
Sign In

SMP-986 Phase 2 Proof of Concept in Patients With Overactive Bladder Syndrome (OABS)

A 10-week Randomised, DB, PG, PC Phase 2 Study to Investigate the Extent of Symptom Relief and the Safety and Tolerability of SMP-986 (20, 40, 80 and 120 mg) Administered Once Daily for 8 Weeks to Patients With Overactive Bladder Syndrome

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00409539
Enrollment
550
Registered
2006-12-11
Start date
2006-12-31
Completion date
2008-07-31
Last updated
2014-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overactive Bladder Syndrome (OABS)

Brief summary

SMP-986 is a compound being developed for the treatment of overactive bladder syndrome (OABS). This clinical study is designed to test the hypothesis that SMP-986 at doses of 20mg, 40mg, 80mg or 120mg provides greater symptom relief in OABS compared to placebo. The hypothesis will be tested by measuring the change in mean voids/24 hrs after treatment with SMP-986 compared to placebo, as well comparing the change in: the severity of urgency episodes, mean number of urgency episodes/24 hr, mean number of incontinence episodes/24 hr and the mean void volume/void between SMP-986 and placebo.

Detailed description

A multicenter study conducted in patients with OABS comprising a 2-week single blind placebo run-in period followed by an 8-week randomized, double-blind, placebo controlled treatment period with patients randomized to receive 20 mg, 40 mg, 80 mg or 120 mg SMP 986 or placebo in a 1:1:1:1:1 ratio in parallel groups on an outpatient basis with study center visits.

Interventions

DRUGPlacebo

Placebo, 2 week duration.

DRUGSMP-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

Sponsors

Dainippon Sumitomo Pharma America
CollaboratorINDUSTRY
ICON Clinical Research
CollaboratorINDUSTRY
ClinPhone, Inc.
CollaboratorINDUSTRY
Covance
CollaboratorINDUSTRY
PPD Development, LP
CollaboratorINDUSTRY
Sumitomo Pharma America, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

Main Inclusion Criteria: * Males, or females who are not of child-bearing potential * Aged 20-80 years (inclusive) with a diagnosis of OABS based on symptomatic reporting over a period of 6 months (micturition frequency, and urgency with or without incontinence) prior to screening.

Exclusion criteria

Main

Design outcomes

Primary

MeasureTime frame
Change From Baseline to Week 8 in the Number of Voids/24 Hours8 Weeks

Secondary

MeasureTime frameDescription
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 Syndrome8 WeeksTreatment emergent adverse event summary

Countries

Estonia, France, Germany, Latvia, Lithuania, Poland, Spain, United Kingdom, United States

Participant flow

Pre-assignment details

550 subjects were enrolled into the 2 week placebo run-in phase prior to randomization.

Participants by arm

ArmCount
Placebo
Placebo run-in phase. 2 week duration. Placebo: Placebo, 2 week duration.
111
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
111
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
109
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
109
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
110
Total550

Baseline characteristics

CharacteristicPlaceboTotal120mg Dose of SMP-98680mg Dose of SMP-98640mg Dose of SMP-98620mg Dose of SMP-986
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
47 Participants229 Participants45 Participants46 Participants43 Participants48 Participants
Age, Categorical
Between 18 and 65 years
64 Participants321 Participants65 Participants63 Participants66 Participants63 Participants
Age, Continuous61.0 years
STANDARD_DEVIATION 11.15
61.4 years
STANDARD_DEVIATION 9.96
61.1 years
STANDARD_DEVIATION 10.08
61.6 years
STANDARD_DEVIATION 9.04
61.5 years
STANDARD_DEVIATION 9.93
62.0 years
STANDARD_DEVIATION 9.6
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
1 Participants5 Participants1 Participants2 Participants1 Participants0 Participants
Race (NIH/OMB)
Black or African American
3 Participants14 Participants6 Participants1 Participants1 Participants3 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
107 Participants531 Participants103 Participants106 Participants107 Participants108 Participants
Region of Enrollment
Estonia
4 participants23 participants6 participants6 participants2 participants5 participants
Region of Enrollment
France
1 participants4 participants1 participants1 participants0 participants1 participants
Region of Enrollment
Germany
29 participants173 participants30 participants39 participants40 participants35 participants
Region of Enrollment
Latvia
7 participants38 participants10 participants7 participants6 participants8 participants
Region of Enrollment
Lithuania
11 participants39 participants3 participants7 participants13 participants5 participants
Region of Enrollment
Poland
31 participants150 participants30 participants30 participants32 participants27 participants
Region of Enrollment
Spain
2 participants12 participants5 participants1 participants1 participants3 participants
Region of Enrollment
United Kingdom
0 participants8 participants0 participants3 participants1 participants4 participants
Region of Enrollment
United States
26 participants103 participants25 participants15 participants14 participants23 participants
Sex: Female, Male
Female
96 Participants465 Participants95 Participants93 Participants89 Participants92 Participants
Sex: Female, Male
Male
15 Participants85 Participants15 Participants16 Participants20 Participants19 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —— / —— / —
other
Total, other adverse events
39 / 11140 / 11150 / 10978 / 10981 / 110
serious
Total, serious adverse events
0 / 1111 / 1111 / 1090 / 1093 / 110

Outcome results

Primary

Change From Baseline to Week 8 in the Number of Voids/24 Hours

Time frame: 8 Weeks

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
PlaceboChange From Baseline to Week 8 in the Number of Voids/24 Hours-1.06 voids/24 hrs.Standard Error 2.223
20mg Dose of SMP-986Change From Baseline to Week 8 in the Number of Voids/24 Hours-1.44 voids/24 hrs.Standard Error 2.402
40mg Dose of SMP-986Change From Baseline to Week 8 in the Number of Voids/24 Hours-1.78 voids/24 hrs.Standard Error 2.376
80mg Dose of SMP-986Change From Baseline to Week 8 in the Number of Voids/24 Hours-2.41 voids/24 hrs.Standard Error 2.383
120mg Dose of SMP-986Change From Baseline to Week 8 in the Number of Voids/24 Hours-1.92 voids/24 hrs.Standard Error 2.145
Secondary

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

Treatment emergent adverse event summary

Time frame: 8 Weeks

ArmMeasureValue (NUMBER)
PlaceboTo 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 Syndrome61 participants
20mg Dose of SMP-986To 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 Syndrome62 participants
40mg Dose of SMP-986To 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 Syndrome61 participants
80mg Dose of SMP-986To 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 Syndrome87 participants
120mg Dose of SMP-986To 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 Syndrome90 participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026