Contact information
Type
Scientific
Primary contact
Dr Christian Hampel
ORCID ID
Contact details
Johannes Gutenberg-Universität Mainz
Department of Urology
Langenbeckstr. 1
Mainz
55131
Germany
+49 (0)6131-17-2310
hampel@urologie.klinik.uni-mainz.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2006-001-Oxy-OAB-Skin-Oxy
Study information
Scientific title
Acronym
Oxy-OAB-Skin-Oxy
Study hypothesis
The primary endpoint is treatment preference of subjects who will be asked at the end of the 2nd treatment period. The preference will be checked for its plausibility in an end-of-period satisfaction rating (6 = very satisfied, 0 = very dissatisfied). Treatment satisfaction will be assessed at the end of each period of the cross over. The total score on the satisfaction visual analog scale of the two treatment periods will be compared to express preference.
Ethics approval
In progress as of 2 February 2007
Study design
Prospective, randomised, open, 2 x 6 - week crossover, single-centre subject preference trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Subjects with overactive bladder (OAB)
Intervention
As of 29/07/09 the status of this trial was updated to 'stopped' due to poor recruitment. The decsion to terminate the trial was made on 25/11/2008, the date of last patient out (LPO) was on 17/07/2009
Test product: Kentera™ TDS 3,9 mg/24h, transdermal patch vs Reference therapy: Oxybutynin ratiopharm® 5 mg, tablets
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Primary efficacy endpoint will be the personal preference of the subject after both treatment phases. The preference will be checked for its plausibility in an end-of-period satisfaction rating (total of scores of final list of questions: 6 = very satisfied, 0 = very dissatisfied)
Secondary outcome measures
1. Cognitive abilities during treatment with orally administered Oxybutynin versus transdermal administration of Oxybutynin measured by CNS tests (Trail Making Test and Wechsler Memorial Scale-Revised)
2. Quality of life assessed with King´s Health Questionnaire
3. Severity of urinary incontinence episodes estimated in pad test at V1, V3, V4 and V6
4. Reports of adverse event (AE)/serious adverse event (SAE) in terms of severity and frequency
5. Frequency of micturition assessed in a 3 day diary in every treatment period
6. Urinary incontinence episodes assessed in a 3 day diary in every treatment period
7. Degree of severity of incontinence episodes estimated in Sandvik Index and documented at subject visits
8. Urgency frequency assessed in a 3 day diary in every treatment period
9. Treatment satisfaction will be assessed with a satisfaction questionnaire at the end of each treatment period
Overall trial start date
01/03/2007
Overall trial end date
01/12/2007
Reason abandoned (if study stopped)
Participant recruitment issue
Eligibility
Participant inclusion criteria
Subjects meeting all of the following criteria will be considered for admission to the trial:
1. Male or female (18 80 years) suffering from OverActive Bladder (OAB)
2. Symptoms of OAB as defined by:
a. Urgency frequency ≥7 /week
b. Urinary urgency incontinence (> 7 UIE/week)
c. Urodynamically proven detrusor instability
3. Women must be surgically sterile, be postmenopausal or must agree to use effective contraception during treatment phases (i.e. contraceptions with a failure ratio of < 1%/ year are implants, injection preparations, combined oral contraceptives, intrauterine device [e.g. hormone spiral] or vasectomy of the partner)
4. Negative urine pregnancy test for women capable of child-bearing within 24 hours before administration of the first dose medication at V1
5. Signed and dated informed consent of the subject must be available before start of any specific trial procedures
6. Ability of subject to understand character and individual consequences of clinical trial
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
It is planned to enroll 80 patients in the trial.
Participant exclusion criteria
Subjects presenting with any of the following criteria will not be included in the trial:
1. Pregnancy and lactation
2. History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product
3. Subjects with significant urinary obstruction as measured during cystometry (e.g. prostatic hyperplasia, stricture of urethra), severe gastro-intestinal condition (e.g. toxic megacolon, severe ulcerative colitis, intestinal atony, bowel obstruction), myasthenia gravis or uncontrolled narrow-angle glaucoma
4. Refractory to antimuscarine treatment: Subjects having experienced no benefit from previous treatment with oral or transdermal oxybutynin
5. Subjects with hiatus hernia and reflux oesophagitis
6. Subjects with acute prostatitis
7. Subjects with urinary frequency or nocturia due to cardiac or renal insufficiency and without urgency
8. Subjects with tachyarrhythmia (pulse > 100/min)
9. Subjects with Parkinsons`s disease or Alzheimer`s disease or other cerebral diseases
10. Subjects with cognitive impairment, not able to understand content and aim of the trial
11. Medical or psychological condition that would not permit completion of the trial or signing of informed consent
12. Participation in other clinical trials and observation period of competing trials, respectively
13. Subjects who have previously been enrolled in the trial
Recruitment start date
01/03/2007
Recruitment end date
01/12/2007
Locations
Countries of recruitment
Germany
Trial participating centre
Johannes Gutenberg-Universität Mainz
Mainz
55131
Germany
Sponsor information
Organisation
Johannes Gutenberg-Universität Mainz, Fachbereich Medizin (Germany)
Sponsor details
c/o Prof J Thüroff
Executive center
Langenbeckstr. 1
Mainz
55131
Germany
+49 (0)6131 17 7183
thueroff@urologie.klinik.uni-mainz.de
Sponsor type
University/education
Website
Funders
Funder type
Industry
Funder name
UCB Farchim S.A. (Switzerland)
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
Basic results (scientific)
Publication list