Additional identifiers
EudraCT number
2006-003730-15
ClinicalTrials.gov number
NCT00409539
Protocol/serial number
D3601113
Study information
Scientific title
A ten week randomised, double-blind, parallel-group, placebo-controlled phase II 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 eight weeks to patients with overactive bladder syndrome
Acronym
Study hypothesis
SMP-986 demonstrates greater efficacy in reducing the symptoms of OverActive Bladder Syndrome (OABS) compared to placebo.
Ethics approval
Ethics approval has been received in the following countries on the dates provided:
1. Estonia, 11/10/2006, Tallinn Medical Research Ethics Committee (ref: 947)
2. Latvia, 07/11/2006, Ethics Committee for Clinical Research of Medicines and Pharmaceutical Products (ref: 201006-6E)
3. Lithuania, 22/11/2006, Lithuanian Bioethics Committee (Nº EudraCT: 2006-003730-15)
4. Poland, 09/11/2006, The Ethics Committee at Instytut Centrum Zdrowia Matki Polki (Nº EudraCT: 2006-003730-15)
5. US central IRB, 09/11/2006, Copernicus Group IRB, NC (Nº EudraCT: 2006-003730-15)
6. Spain, 12/01/2007, Ethic Committee of Hospital Universitario de Canarias(Nº EudraCT: 2006-003730-15)
7. Germany, 05/01/2007, Ethics Committee of the Medical Faculty, Ludwig-Maximilians-University (Nº EudraCT: 2006-003730-15)
8. UK, 22/01/2007, Huntingdon Local Research Ethics (ref: 06/Q0104/119)
9. France, 08/03/2007, Paris CPP (ref: 2006/61)
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
OverActive Bladder Syndrome (OABS)
Intervention
Added 06/08/2008: Patient follow-up was completed on the 05/06/2008.
SMP-986 (20mg, 40mg, 80mg, 120 mg) or placebo. The treatment is delivered as tablets taken orally for a total of ten weeks.
Intervention type
Drug
Phase
Phase II
Drug names
SMP-986
Primary outcome measures
To quantify the extent of symptomatic relief provided by 20, 40, 80 and 120 mg SMP 986 (once daily [o.d.]) following eight-weeks of treatment in patients with OABS.
Secondary outcome measures
1. To assess the safety and tolerability of 20, 40, 80 and 120 mg SMP 986 (o.d.) following eight-weeks of treatment in patients with OABS
2. To determine the most clinically appropriate dose range for SMP-986 in terms of treatment benefit (efficacy, safety, tolerability and Quality of Life outcomes)
Overall trial start date
01/12/2006
Overall trial end date
19/06/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Males, or females who are not of child bearing potential. Female subjects must be either postmenopausal, surgically sterile or using a highly effective non oral form of contraception.
2. Aged 20 to 80 years (inclusive)
3. Diagnosis of OABS based on symptomatic reporting over a period of more than six months (micturition frequency, and urgency with or without incontinence) prior to screening.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Approximately 710 patients
Participant exclusion criteria
1. Patients with an indication of any bladder outlet obstruction or polyuria
2. Patients with the following conditions, or who have undergone the following procedures, will be excluded:
2.1. Stress urinary incontinence
2.2. Pelvic organ prolapse (more than stage two)
2.3. Genitourinary or lower bowel surgery (within 12 months prior to screening),
2.4. Pathological conditions including poorly controlled diabetes, painful bladder syndrome/interstitial cystitis or history of chronic urinary tract infection
2.5. Neurological conditions including multiple sclerosis, Parkinson's disease or neuropathy)
3. Patients will also be excluded if they have an indwelling catheter or perform intermittent self catheterisation
4. Patients should not have a current or past medical condition contraindicating the use of antimuscarinics and must have discontinued use of the following drugs:
4.1. Drugs used to treat OABS or urinary incontinence
4.2. Cholinergics
4.3. Anticholinergics
4.4. Alpha adrenergic antagonists
4.5. Opioid analgesics
4.6. Compound analgesics containing an opioid
4.7. Warfarin
5. Patients with a current or past malignancy (within the last five years), and patients who have ever had a tumour affecting the genitourinary tract (not including benign prostatic hyperplasia)
6. 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
7. Patients unable to complete the study diary
Recruitment start date
01/12/2006
Recruitment end date
19/06/2008
Locations
Countries of recruitment
Estonia, France, Germany, Latvia, Lithuania, Poland, Spain, United Kingdom, United States of America
Trial participating centre
Clinical Department
London
SW1E 6QT
United Kingdom
Sponsor information
Organisation
Dainippon Sumitomo Pharma Europe Ltd (UK)
Sponsor details
Southside
97-105 Victoria Street
London
SW1E 6QT
United Kingdom
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Dainippon Sumitomo Pharma Co., Ltd (UK)
Alternative name(s)
Dainippon Sumitomo Pharma Co., Ltd.
Funding Body Type
private sector organisation
Funding Body Subtype
corporate
Location
Japan
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
See https://clinicaltrials.gov/ct2/show/results/NCT00409539
Publication summary