Condition category
Urological and Genital Diseases
Date applied
31/01/2007
Date assigned
22/03/2007
Last edited
30/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes