Propiverine Hydrochloride Extended-Release Capsule for Overactive Bladder

This study has been completed.
Sponsor:
Collaborator:
APOGEPHA Arzneimittel GmbH
Information provided by (Responsible Party):
Lee's Pharmaceutical Limited
ClinicalTrials.gov Identifier:
NCT01512004
First received: November 24, 2010
Last updated: January 24, 2012
Last verified: January 2012

November 24, 2010
January 24, 2012
January 2010
January 2010   (final data collection date for primary outcome measure)
Alteration of mean micturition frequency within 24h on the basis of continuous 3-day record [ Time Frame: prior to medication and 8 weeks after medication ] [ Designated as safety issue: Yes ]
The voiding frequency per 24 hours, and the alteration of mean micturition frequency within 24 hours on the basis of continuous 3-day record, prior to medication and 8 weeks after medication
Same as current
Complete list of historical versions of study NCT01512004 on ClinicalTrials.gov Archive Site
The alteration of mean incontinence frequency and mean micturition frequency and volume within 24 hours on the basis of continuous 3-day record [ Time Frame: prior to medication, 2 weeks and 8 weeks after medication ] [ Designated as safety issue: Yes ]
The alteration of mean incontinence frequency, mean micturition frequency and volume within 24 hous on the basis of continuous 3-day record,prior to medication, 2 weeks and 8 weeks after medication. Additionaly, to evaluate the subject's feeling of treatment benefit and the time of the drug effect onset.
Same as current
Not Provided
Not Provided
 
Propiverine Hydrochloride Extended-Release Capsule for Overactive Bladder
Phase III Study of Propiverine Hydrochloride Extended-Release Capsule in the Treatment of Overactive Bladder (OAB) in Chinese Population With Urgent Micturition, Frequent Micturition and/or Urge Urinary Incontinence

The purpose of this Phase III study is to evaluate the efficacy and safety of Propiverine Hydrochloride Extended-Release Capsule in the treatment of overactive bladder in Chinese population with urgent micturition, frequent micturition and/or urge urinary incontinence.

This is a multi-center, randomized, doubled-blind, double dummy clinical study, in comparison with Tolterodine Tartrate Extended-Release Tablet as active parallel control to evaluate the efficacy and safety of Propiverine Hydrochloride Extended-Release Capsule in the treatment of Overactive Bladder in Chinese population with urgent micturition, frequent micturition and/or urge urinary incontinence.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Overactive Bladder
  • Drug: Propiverine Hydrochloride
    drug of oral capsule
    Other Names:
    • Mictonorm
    • Propierine Hydrochloride Extended-Release Capsule
  • Drug: Tolterodine Extended-release Tablet
    4mg/tablet; oral; once per day
  • Active Comparator: Propiverine Hydrochloride Extended-Release Capsule
    30 mg/capsule; oral; once per day
    Intervention: Drug: Propiverine Hydrochloride
  • Placebo Comparator: Tolterodine Extended-release Tablet
    4mg/tablet; oral; once per day
    Intervention: Drug: Tolterodine Extended-release Tablet
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
324
August 2011
January 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Aged 18 to 65, male or female patient has a diagnosis of overactive bladder and the symptoms of OAB>3 months subject has urinary frequency (average micturition frequency within 24h>8 times), urgency and/or urge incontinence by micturition diary card during screening period
  • Mean volume of single micturition is less than 200ml by micturition diary dard during screening period
  • The subject is willing and able to complete the micturition diary card correctly
  • Subject's urine routine test show that he/she has no urinary tract infection Subject signs informed consent form

Exclusion Criteria:

  • Confirmed by the investigator that subject has severe stress incontinence.
  • Subject who has serious heart disease or arrhythmia, in the investigator's opinion, is not suitable to enroll.
  • Subject who has contraindications of anticholinergic therapy, such as urinary retention, gastric retention and uncontrollable angle closure glaucoma.
  • Subject who has a symptomatic acute urinary tract infection.
  • Subject who has a recurrent urinary tract infection.
  • Subject who has interstitial cystitis.
  • Subject who has an agnogenic hematuria.
  • Subject who has a bladder outlet obstruction of clinical significance.
  • Subject who needs retention catheterization or intermittent catheterization.
  • Patient with malignant tumor.
  • Subject who has received anticholinergic drugs or other drugs for treating OAB within washout period, or who will receive these drugs after this study begins.
  • Subject who is pregnant or lactating, or plans to be pregnant subject who has received other clinical study drugs or its participating in other clinical trial within 30 days.
  • Women of childbearing age who has not taken sufficient contraception measures within 3 months before random number distribution; or intends to stop the contraception measures during the trial or within one month after the treatment is over.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01512004
LEES-MIC
Yes
Lee's Pharmaceutical Limited
Lee's Pharmaceutical Limited
APOGEPHA Arzneimittel GmbH
Study Director: Benjamin Li, PhD Lee's Pharmaceutical
Lee's Pharmaceutical Limited
January 2012

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