NCT01530620

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2004

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
5.6 years until next milestone

First Submitted

Initial submission to the registry

February 2, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 10, 2012

Completed
Last Updated

February 10, 2012

Status Verified

February 1, 2012

Enrollment Period

6 months

First QC Date

February 2, 2012

Last Update Submit

February 9, 2012

Conditions

Neurogenic Urinary Bladder DisorderUrinary Bladder, NeurogenicBladder Disorder, NeurogenicUrinary Bladder Disorder, NeurogenicNeurogenic Bladder DisorderUrinary Bladder Neurogenic DysfunctionUrologic DiseasesOveractive Detrusor FunctionUrinary Incontinence

Keywords

AntimuscarinicsNeurogenic bladderPropiverineUrodynamics

Outcome Measures

Primary Outcomes (1)

  • Reflex volume (cystometry)

    Change in reflex volume compared to baseline and compared between the two treatment arms

    three weeks

Secondary Outcomes (9)

  • Leak point pressure

    three weeks

  • Leak point volume

    three weeks

  • Maximum detrusor pressure

    three weeks

  • Maximum cystometric capacity

    three weeks

  • Bladder compliance

    three weeks

  • +4 more secondary outcomes

Study Arms (2)

Propiverine hydrochloride ER

EXPERIMENTAL

45 mg

Drug: Propiverine hydrochloride ER (extended release)

Propiverine hydrochloride IR

ACTIVE COMPARATOR

15 mg

Drug: Propiverine hydrochloride IR (immediate release)

Interventions

Propiverine hydrochloride ER (extended release)DRUG

45 mg capsule (1x1/d)

Also known as: Mictonorm UNO 45, Detrunorm XL 45
Propiverine hydrochloride ER
Propiverine hydrochloride IR (immediate release)DRUG

15 mg tablet (3x1/d)

Also known as: Mictonorm, Detrunorm
Propiverine hydrochloride IR

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Graz, Austria

Location

Unknown Facility

Hagenow, Germany

Location

Unknown Facility

Bucharest, Romania

Location

MeSH Terms

Conditions

Urinary Bladder, NeurogenicUrologic DiseasesUrinary Bladder, OveractiveUrinary Incontinence

Interventions

propiverine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesUrinary Bladder DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsLower Urinary Tract SymptomsUrological ManifestationsUrination Disorders

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2012

First Posted

February 10, 2012

Study Start

December 1, 2004

Primary Completion

June 1, 2005

Study Completion

July 1, 2006

Last Updated

February 10, 2012

Record last verified: 2012-02

Locations

AU(1)DE(1)RO(1)