Condition category
Urological and Genital Diseases
Date applied
12/06/2008
Date assigned
04/07/2008
Last edited
13/07/2012
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

Mr Joseph Reiz

ORCID ID

Contact details

Purdue Pharma
575 Granite Court
Pickering
L1W 3W8
Canada

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

018-010

Study information

Scientific title

Acronym

STOP

Study hypothesis

Patients and physician satisfaction with study drug 018 will not be different in elderly and non-elderly patients.

Ethics approval

Ethics approval for the lead centre was obtained from IRB Services, Aurora, Ontario (Canada) on November 23, 2006. All other participating centres obtained ethics approval before recruiting study patients.

Study design

Multi-centred open label trial

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format. Please have your family physician use the contact details below to request information on the study.

Condition

Overactive bladder

Intervention

Oral anticholinergic-antispasmodic (018) over a four-week open label phase.

Intervention type

Drug

Phase

Not Specified

Drug names

Study drug 018

Primary outcome measures

Measured after four weeks of treatment:
1. Quality of life
2. Patient and physician satisfaction

Secondary outcome measures

Measured after four weeks of treatment:
1. Tolerability
2. Cognitive status
3. Adverse events

Overall trial start date

07/01/2007

Overall trial end date

31/12/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Males or non-pregnant, non-nursing females greater than or equal to 18 years of age
2. Diagnosis of overactive bladder and currently experiencing incontinent episodes and frequent micturitions or urgency
3. Newly diagnosed patients or patients not currently taking medication for overactive bladder
4. Capable of completing questionnaires in English or French

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

300

Participant exclusion criteria

1. Patient who will initiate treatment with any drug prescribed for the treatment of overactive bladder (except oestrogen) during the study period
2. Patient with a primary diagnosis of stress incontinence or a concurrent diagnosis of functional or overflow incontinence
3. Patients with conditions contra-indicating anticholinergic therapy or have hepatic or renal disease
4. Patients using an indwelling catheter or who had bladder electrostimulation therapy or participated in bladder training within the previous 14 days prior to study entry

Recruitment start date

07/01/2007

Recruitment end date

31/12/2007

Locations

Countries of recruitment

Canada

Trial participating centre

Purdue Pharma
Pickering
L1W 3W8
Canada

Sponsor information

Organisation

Purdue Pharma Canada

Sponsor details

c/o Joseph L. Reiz
575 Granite Court
Pickering
L1W 3W8
Canada
+1 905 420 6400
medinfo@purdue.ca

Sponsor type

Industry

Website

http://www.purdue.ca

Funders

Funder type

Industry

Funder name

Purdue Pharma Canada

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Publication summary

2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22769237

Publication citations

  1. Results

    Aaron LE, Morris TJ, Jahshan P, Reiz JL, An evaluation of patient and physician satisfaction with controlled-release oxybutynin 15 mg as a one-step daily dose in elderly and non-elderly patients with overactive bladder: results of the STOP study., Curr Med Res Opin, 2012, 28, 8, 1369-1379, doi: 10.1185/03007995.2012.709837.

Additional files

Editorial Notes