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

Purpose

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.

Condition	Intervention	Phase
Overactive Bladder Syndrome (OABS)	Drug: Placebo Drug: SMP-986	Phase II

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	A 10-Week Randomised, Double-Blind, Parallel-Group, Placebo-Controlled Phase 2 Study to Investigate the Extent of Symptom Relief and the Safety and Tolerability of SMP-986 (20 mg, 40 mg, 80 mg and 120 mg) Administered Once Daily for 8 Weeks to Patients With Overactive Bladder Syndrome

Further study details as provided by Dainippon Sumitomo Pharma Europe LTd.:

Primary Outcome Measures:

To quantify the extent of symptomatic relief provided by 20, 40, 80 and 120 mg SMP 986 (o.d) following 8-weeks of treatment in patients with OABS [ Time Frame: Study End ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 OABS [ Time Frame: Study End ] [ Designated as safety issue: Yes ]
To determine the most clinically appropriate dose range for SMP-986 in terms of treatment benefit (efficacy, safety, tolerability and Quality of Life outcomes) [ Time Frame: Study End ] [ Designated as safety issue: Yes ]

Enrollment:	551
Study Start Date:	December 2006
Study Completion Date:	July 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator Placebo run-in phase. 2 week duration.	Drug: Placebo Placebo, 2 week duration.
2: Placebo Comparator To be taken for the 8 week duration, in parallel with alternative arms (doses of 20, 40, 80 or 120mg SMP-986).	Drug: Placebo Taken for the 8 week duration, in parallel with alternative arms (doses of 20, 40, 80 or 120mg SMP-986).
3: Experimental 20mg dose of SMP-986 to be taken once daily for 8 week duration.	Drug: 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
4: Experimental 40mg dose of SMP-986 to be taken for 8 week duration.	Drug: 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
5: Experimental 80mg dose of SMP-986 to be taken for 8 week duration.	Drug: 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
6: Experimental 120mg dose of SMP-986 to be taken for 8 week duration.	Drug: 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

Eligibility

Ages Eligible for Study:	20 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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 Exclusion Criteria:

Patients will be excluded if there is an indication of any bladder outlet obstruction or polyuria
Patients with the following conditions, or who have undergone the following procedures, will be excluded:
- stress urinary incontinence
- pelvic organ prolapse ( stage 2)
- genitourinary or lower bowel surgery (within 12 months prior to screening),
- pathological conditions including poorly controlled diabetes, painful bladder syndrome/interstitial cystitis or history of chronic urinary tract infection
- neurological conditions including multiple sclerosis, Parkinson's disease or neuropathy)
Patients will also be excluded if they have an indwelling catheter or perform intermittent self catheterisation
Patients should not have a current or past medical condition contraindicating the use of antimuscarinics and must have discontinued use of the following drugs:
- drugs used to treat OABS or urinary incontinence
- cholinergics
- anticholinergics
- alpha adrenergic antagonists
- opioid analgesics
- compound analgesics containing an opioid
- warfarin
Patients with a current or past malignancy (within the last 5 years)
Patients who have ever had a tumour affecting the genitourinary tract (not including benign prostatic hyperplasia) will be excluded.
Patients will be ineligible if they have a clinically significant cardiac, neurological, hepatic, renal, respiratory, haematological or gastrointestinal disorder (including, a significant history of constipation or an active bowel disease e.g. inflammatory bowel disease) or any other illness which in the opinion of the Investigator would preclude the safe or compliant participation of a subject.
Patients will be excluded if they are unable to complete the study diary

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00409539

Show 69 Study Locations

Sponsors and Collaborators

Dainippon Sumitomo Pharma Europe LTd.

Dainippon Sumitomo Pharma America

ICON Clinical Research

ClinPhone, Inc.

Covance

PPD

Investigators


Principal Investigator:	Prof C Chappel	Royal Hallamshire Hospital

More Information

Responsible Party:	Dainippon Sumitomo Pharma Europe Ltd ( Dainippon Sumitomo Pharma Europe Ltd. )
Study ID Numbers:	D3601113
First Received:	December 8, 2006
Last Updated:	August 4, 2008
ClinicalTrials.gov Identifier:	NCT00409539
Health Authority:	United States: Food and Drug Administration; European Union: European Medicines Agency; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Latvia: State Agency of Medicines; Poland: Ministry of Scientific Research and Information Technology; Spain: Comité Ético de Investigación Clínica; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study placed in the following topic categories:

Signs and Symptoms

Urinary Bladder, Overactive

Urologic Diseases

Urinary Bladder Diseases

Additional relevant MeSH terms:

Urological Manifestations

Pathologic Processes

Disease

Syndrome

ClinicalTrials.gov processed this record on October 22, 2008

Sponsors and Collaborators:	Dainippon Sumitomo Pharma Europe LTd. Dainippon Sumitomo Pharma America ICON Clinical Research ClinPhone, Inc. Covance PPD
Information provided by:	Dainippon Sumitomo Pharma Europe LTd.
ClinicalTrials.gov Identifier:	NCT00409539