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

Primary Purpose

Multiple Sclerosis, Overactive Detrusor

Status

Terminated

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

Darifenacin (BAY79-4998)

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Darifenacin, Multiple Sclerosis, Open Label Study

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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
17 Additional Exclusion Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in volume at first detrusor contraction as determined by urodynamics

Secondary Outcome Measures

Detrusor pressure at first contraction

Volume at first detectable leakage

Volume at 10/20/30/40 cm H2O

Compliance

Maximum cystometric bladder capacity

7-day micturition diary: Micturitions

7-day micturition diary: Urgency episodes

7-day micturition diary: Urge urinary incontinence episodes

Full Information

NCT ID

NCT00845338

First Posted

February 16, 2009

Last Updated

November 28, 2014

Sponsor

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT00845338

Brief Title

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

Official Title

A 4-week, Open-label, Multicenter, Urodynamic Pilot Study to Explore the Efficacy, Tolerability and Safety of Darifenacin (7.5 mg With Up-titration to 15 mg) in Patients With Multiple Sclerosis and Neurogenic Detrusor Overactivity

Study Type

Interventional

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Terminated

Why Stopped

The enrollment rate at most centers was unlikely to result in the recruitment of the planned sample size of 40 evaluable subjects.

Study Start Date

February 2007 (undefined)

Primary Completion Date

October 2007 (Actual)

Study Completion Date

October 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bayer

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Sclerosis, Overactive Detrusor

Keywords

Darifenacin, Multiple Sclerosis, Open Label Study

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

7 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Darifenacin (BAY79-4998)

Intervention Description

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

Primary Outcome Measure Information:

Title

Change from baseline in volume at first detrusor contraction as determined by urodynamics

Time Frame

At week 4

Secondary Outcome Measure Information:

Title

Detrusor pressure at first contraction

Time Frame

At week 4

Title

Volume at first detectable leakage

Time Frame

At week 4

Title

Volume at 10/20/30/40 cm H2O

Time Frame

At week 4

Title

Compliance

Time Frame

At week 4

Title

Maximum cystometric bladder capacity

Time Frame

At week 4

Title

7-day micturition diary: Micturitions

Time Frame

At days 0, 14, 28

Title

7-day micturition diary: Urgency episodes

Time Frame

At days 0, 14, 28

Title

7-day micturition diary: Urge urinary incontinence episodes

Time Frame

At days 0, 14, 28

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 17 Additional Exclusion Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bayer Study Director

Organizational Affiliation

Bayer

Official's Role

Study Director

Facility Information:

City

Emmendingen

State/Province

Baden-Württemberg

ZIP/Postal Code

79312

Country

Germany

City

Heidelberg

State/Province

Baden-Württemberg

ZIP/Postal Code

69112

Country

Germany

City

Lahr

State/Province

Baden-Württemberg

ZIP/Postal Code

77933

Country

Germany

City

Tübingen

State/Province

Baden-Württemberg

ZIP/Postal Code

72076

Country

Germany

City

Villingen-Schwenningen

State/Province

Baden-Württemberg

ZIP/Postal Code

78054

Country

Germany

City

Planegg

State/Province

Bayern

ZIP/Postal Code

82152

Country

Germany

City

Oberursel

State/Province

Hessen

ZIP/Postal Code

61440

Country

Germany

City

Herne

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

44627

Country

Germany

City

Mönchengladbach

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

41063

Country

Germany

City

Mülheim

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

45468

Country

Germany

City

Mainz

State/Province

Rheinland-Pfalz

ZIP/Postal Code

55131

Country

Germany

City

Halle

State/Province

Sachsen-Anhalt

ZIP/Postal Code

06112

Country

Germany

City

Bad Berka

State/Province

Thüringen

ZIP/Postal Code

99437

Country

Germany

City

Berlin

ZIP/Postal Code

10115

Country

Germany

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

12. IPD Sharing Statement

Links:

URL

http://www.clinicaltrialsregister.eu/

Description

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

Learn more about this trial

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

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