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
| ISRCTN | ISRCTN63089812 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN63089812 |
| EudraCT/CTIS number | 2006-003730-15 |
| ClinicalTrials.gov number | NCT00409539 |
| Secondary identifying numbers | D3601113 |
- Submission date
- 01/12/2006
- Registration date
- 19/12/2006
- Last edited
- 15/04/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Chris Chapple
Scientific
Scientific
Clinical Department
Southside
97-105 Victoria Street
London
SW1E 6QT
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study objectives | SMP-986 demonstrates greater efficacy in reducing the symptoms of OverActive Bladder Syndrome (OABS) compared to placebo. |
| Ethics approval(s) | 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) |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | SMP-986 |
| Primary outcome measure | 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 study start date | 01/12/2006 |
| Completion date | 19/06/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Approximately 710 patients |
| Key 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. |
| Key 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 |
| Date of first enrolment | 01/12/2006 |
| Date of final enrolment | 19/06/2008 |
Locations
Countries of recruitment
- England
- Estonia
- France
- Germany
- Latvia
- Lithuania
- Poland
- Spain
- United Kingdom
- United States of America
Study participating centre
Clinical Department
London
SW1E 6QT
United Kingdom
SW1E 6QT
United Kingdom
Sponsor information
Dainippon Sumitomo Pharma Europe Ltd (UK)
Industry
Industry
Southside
97-105 Victoria Street
London
SW1E 6QT
United Kingdom
| Website | http://www.ds-pharma.co.jp/english/index.html |
|---|---|
"ROR" |
https://ror.org/03sh4z743 |
Funders
Funder type
Industry
Dainippon Sumitomo Pharma Co., Ltd (UK)
Private sector organisation / For-profit companies (industry)
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Dainippon Sumitomo Pharma Co., Ltd.
- Location
- Japan
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | No | No | |||
| Basic results | No | No |
Editorial Notes
15/04/2019: Added EudraCT link to basic results (scientific).
08/04/2016: No publications found, verifying study status with principal investigator
21/03/2016: Added link to results - basic reporting.
21/05/2008: The overall trial end date was changed from 28/02/2008 to 19/06/2008.
