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Efficacy and Tolerability of Propiverine Hydrochloride in Patients With Neurogenic Detrusor Overactivity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01530620
Recruitment Status : Completed
First Posted : February 10, 2012
Last Update Posted : February 10, 2012
Sponsor:
Information provided by (Responsible Party):
APOGEPHA Arzneimittel GmbH

Tracking Information
First Submitted Date  ICMJE February 2, 2012
First Posted Date  ICMJE February 10, 2012
Last Update Posted Date February 10, 2012
Study Start Date  ICMJE December 2004
Actual Primary Completion Date June 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 9, 2012)
Reflex volume (cystometry) [ Time Frame: three weeks ]
Change in reflex volume compared to baseline and compared between the two treatment arms
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 9, 2012)
  • Leak point pressure [ Time Frame: three weeks ]
    Change in LPP compared to baseline and compared between the two treatment arms
  • Leak point volume [ Time Frame: three weeks ]
    Change in LPV compared to baseline and compared between the two treatment arms
  • Maximum detrusor pressure [ Time Frame: three weeks ]
    Change in maximum p det compared to baseline and compared between the two treatment arms
  • Maximum cystometric capacity [ Time Frame: three weeks ]
    Change in maximum cystometric capacity compared to baseline and compared between the two treatment arms
  • Bladder compliance [ Time Frame: three weeks ]
    Change in compliance compared to baseline and compared between the two treatment arms
  • Change in number of incontinence episodes [ Time Frame: three weeks ]
    Change of incontinence episodes compared to baseline and compared between the two treatment arms
  • State of Well-Being Questionnaire [ Time Frame: three weeks ]
    Change of well-beeing compared to baseline and compared between the two treatment arms
  • Post void residual volume [ Time Frame: three weeks ]
    Change in PVR compared to baseline and compared between the two treatment arms
  • Incidence and severity of adverse events [ Time Frame: three weeks ]
    occurrences and intensity of adverse events or withdrawals over the whole treatment period
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Tolerability of Propiverine Hydrochloride in Patients With Neurogenic Detrusor Overactivity
Official Title  ICMJE Efficacy and Tolerability of Propiverine Hydrochloride Extended Release (ER) Compared to Immediate Release (IR) in Patients With Neurogenic Detrusor Overactivity. A Randomized, Double Blind, Parallel Group, Multicenter Clinical Trial
Brief Summary The purpose of this clinical study is to compare efficacy and safety of propiverine hydrochloride extended and immediate release formulations in patients suffering from neurogenic detrusor overactivity.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Neurogenic Urinary Bladder Disorder
  • Urinary Bladder, Neurogenic
  • Bladder Disorder, Neurogenic
  • Urinary Bladder Disorder, Neurogenic
  • Neurogenic Bladder Disorder
  • Urinary Bladder Neurogenic Dysfunction
  • Urologic Diseases
  • Overactive Detrusor Function
  • Urinary Incontinence
Intervention  ICMJE
  • Drug: Propiverine hydrochloride ER (extended release)
    45 mg capsule (1x1/d)
    Other Names:
    • Mictonorm UNO 45
    • Detrunorm XL 45
  • Drug: Propiverine hydrochloride IR (immediate release)
    15 mg tablet (3x1/d)
    Other Names:
    • Mictonorm
    • Detrunorm
Study Arms  ICMJE
  • Experimental: Propiverine hydrochloride ER
    45 mg
    Intervention: Drug: Propiverine hydrochloride ER (extended release)
  • Active Comparator: Propiverine hydrochloride IR
    15 mg
    Intervention: Drug: Propiverine hydrochloride IR (immediate release)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 9, 2012)
66
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2006
Actual Primary Completion Date June 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female Caucasian patients aged ≥18 and ≤70 years
  • Voluntarily signed informed consent
  • Neurogenic detrusor overactivity with occurrence of reflex detrusor contractions
  • Reflex volume of ≤250 mL
  • Intact reflex arcs in the area of segments S2-S4

Exclusion Criteria:

  • Patients suffering from multiple sclerosis under unstable conditions
  • Augmented reflex bladder
  • Patients with increased residual urine (≥20 % of the maximum bladder capacity), in whom catheterization is not possible
  • Acute urinary tract infection
  • Electrostimulation therapy (within 4 weeks propir to Visit 1)
  • Anomalies of the lower genitourinary tract (e.g. ectopic ureters, fistulas, urethral stenosis)
  • Radiation bladder, interstitial cystitis, bladder calculi, bladder carcinoma
  • Surgery of the lower genitourinary tract within the last 6 months (e.g. prostatectomy, hysterectomy, tumor surgery)
  • Pre-existing medical contraindications for anticholinergics
  • Cardiac insufficiency (NYHA stage III/ IV)
  • Therapy with botulinum toxin within the last 12 months
  • Evidence of severe renal, hepatic or metabolic disorders
  • History of drug or alcohol abuse
  • Concomitant medication known to have a potential to interfere with the trial medication
  • Known hypersensitivity to Propiverine hydrochloride or excipients contained in the trial medication, respectively
  • Pregnant or breast-feeding women, or women of childbearing potential without using any reliable contraceptive method
  • Patients with impaired co-operation or who are unable to understand the nature, scope and possible consequences of the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Germany,   Romania
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01530620
Other Study ID Numbers  ICMJE 8405010
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party APOGEPHA Arzneimittel GmbH
Study Sponsor  ICMJE APOGEPHA Arzneimittel GmbH
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account APOGEPHA Arzneimittel GmbH
Verification Date February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP