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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

APOGEPHA Arzneimittel GmbH

ClinicalTrials.gov Identifier:

NCT01530620

First received: February 2, 2012

Last updated: February 9, 2012

Last verified: February 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	February 2, 2012
Last Updated Date	February 9, 2012
Start Date ^ICMJE	December 2004
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 ] [ Designated as safety issue: No ] Change in reflex volume compared to baseline and compared between the two treatment arms
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01530620 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: February 9, 2012)	Leak point pressure [ Time Frame: three weeks ] [ Designated as safety issue: No ] Change in LPP compared to baseline and compared between the two treatment arms Leak point volume [ Time Frame: three weeks ] [ Designated as safety issue: No ] Change in LPV compared to baseline and compared between the two treatment arms Maximum detrusor pressure [ Time Frame: three weeks ] [ Designated as safety issue: No ] Change in maximum p det compared to baseline and compared between the two treatment arms Maximum cystometric capacity [ Time Frame: three weeks ] [ Designated as safety issue: No ] Change in maximum cystometric capacity compared to baseline and compared between the two treatment arms Bladder compliance [ Time Frame: three weeks ] [ Designated as safety issue: No ] Change in compliance compared to baseline and compared between the two treatment arms Change in number of incontinence episodes [ Time Frame: three weeks ] [ Designated as safety issue: No ] Change of incontinence episodes compared to baseline and compared between the two treatment arms State of Well-Being Questionnaire [ Time Frame: three weeks ] [ Designated as safety issue: No ] Change of well-beeing compared to baseline and compared between the two treatment arms Post void residual volume [ Time Frame: three weeks ] [ Designated as safety issue: Yes ] Change in PVR compared to baseline and compared between the two treatment arms Incidence and severity of adverse events [ Time Frame: three weeks ] [ Designated as safety issue: Yes ] occurrences and intensity of adverse events or withdrawals over the whole treatment period
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	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	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 Arm (s)	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
Enrollment ^ICMJE	66
Completion Date	July 2006
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
Gender	Both
Ages	18 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Austria, Germany, Romania

Administrative Information
NCT Number ^ICMJE	NCT01530620
Other Study ID Numbers ^ICMJE	8405010
Has Data Monitoring Committee	No
Responsible Party	APOGEPHA Arzneimittel GmbH
Study Sponsor ^ICMJE	APOGEPHA Arzneimittel GmbH
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	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

To Top