Condition category
Urological and Genital Diseases
Date applied
01/12/2006
Date assigned
19/12/2006
Last edited
08/04/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Chris Chapple

ORCID ID

Contact details

Clinical Department
Southside
97-105 Victoria Street
London
SW1E 6QT
United Kingdom

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

http://www.ds-pharma.co.jp/english/index.html

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

Publication citations

Additional files

Editorial Notes

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.