MedDataX Logo

Study of Darifenacin in Patients Suffering From Multiple Sclerosis and Neurogenic Detrusor Overactivity

NCT ID: NCT00845338

Last Updated: 2014-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2007-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The objective of this study is to explore the effects of darifenacin in patients with multiple sclerosis and neurogenic detrusor overactivity. The efficacy, safety and tolerability of darifenacin are already well established in idiopathic detrusor overactivity. Patients with multiple sclerosis and neurogenic detrusor overactivity without detrusor-sphincter-dyssynergia (DSD) will be allocated to darifenacin therapy.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Multiple Sclerosis Overactive Detrusor

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm 1

Group Type EXPERIMENTAL

Darifenacin (BAY79-4998)

Intervention Type DRUG

Darifenacin 7,5mg tablets once daily for 14 days, darifenacin 7,5mg or 15mg once daily for 14 consecutive days

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Darifenacin (BAY79-4998)

Darifenacin 7,5mg tablets once daily for 14 days, darifenacin 7,5mg or 15mg once daily for 14 consecutive days

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients with multiple sclerosis for at least 6 months
* Neurogenic detrusor overactivity without DSD
* Symptoms of OAB
* Patients capable of completing the bladder diary
* Patients capable of independent toileting
* Patients able to swallow the study medication in accordance to the protocol
* Body Mass Index \>/= 18,8 kg/qm and \</= 35,0 kg/qm
* documented, dated, written informed consent

Exclusion Criteria

* Treatment with drugs known to affect mainly the urinary function 14 days prior to starting completion of the baseline diary for Visit 2
* Participation in a bladder-training program
* Low compliance bladder (Compliance \<20 mL/cm H2O)
* DSD, Detrusor hyporeflexia / areflexia and bradykinesia / tremor of the external urethral sphincter
* Indwelling catheter or intermittent self-catheterization
* Patience with post-void residual (PVR) urinary volume \> 200 mL at baseline
* Urinary retention or clinically significant bladder outlet obstruction as detected by the investigator
* Clinically predominant and bothersome stress urinary incontinence
* Neurological diseases other than multiple sclerosis affecting urinary bladder function
* Any urogenital surgery within 12 month prior to Visit 1
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Emmendingen, Baden-Wurttemberg, Germany

Site Status

Heidelberg, Baden-Wurttemberg, Germany

Site Status

Lahr, Baden-Wurttemberg, Germany

Site Status

Tübingen, Baden-Wurttemberg, Germany

Site Status

Villingen-Schwenningen, Baden-Wurttemberg, Germany

Site Status

Planegg, Bavaria, Germany

Site Status

Hamburg, City state of Hamburg, Germany

Site Status

Oberursel, Hesse, Germany

Site Status

Herne, North Rhine-Westphalia, Germany

Site Status

Mönchengladbach, North Rhine-Westphalia, Germany

Site Status

Mülheim, North Rhine-Westphalia, Germany

Site Status

Mainz, Rhineland-Palatinate, Germany

Site Status

Halle, Saxony-Anhalt, Germany

Site Status

Berlin, State of Berlin, Germany

Site Status

Bad Berka, Thuringia, Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Related Links

Access external resources that provide additional context or updates about the study.

http://www.clinicaltrialsregister.eu/

Click here to find information about studies related to Bayer Healthcare products conducted in Europe

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2006-002361-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

12331

Identifier Type: -

Identifier Source: org_study_id