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
  Purpose

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.


Condition Intervention Phase
Overactive Bladder
Drug: Propiverine Hydrochloride
Drug: Tolterodine Extended-release Tablet
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Lee's Pharmaceutical Limited:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Enrollment: 324
Study Start Date: January 2010
Study Completion Date: August 2011
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Propiverine Hydrochloride Extended-Release Capsule
30 mg/capsule; oral; once per day
Drug: Propiverine Hydrochloride
drug of oral capsule
Other Names:
  • Mictonorm
  • Propierine Hydrochloride Extended-Release Capsule
Placebo Comparator: Tolterodine Extended-release Tablet
4mg/tablet; oral; once per day
Drug: Tolterodine Extended-release Tablet
4mg/tablet; oral; once per day

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01512004

Locations
China
Beijing Chaoyang Hospital
Beijing, China
Sponsors and Collaborators
Lee's Pharmaceutical Limited
APOGEPHA Arzneimittel GmbH
Investigators
Study Director: Benjamin Li, PhD Lee's Pharmaceutical
  More Information

No publications provided

Responsible Party: Lee's Pharmaceutical Limited
ClinicalTrials.gov Identifier: NCT01512004     History of Changes
Other Study ID Numbers: LEES-MIC
Study First Received: November 24, 2010
Last Updated: January 24, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Lee's Pharmaceutical Limited:
Overactive Bladder
urgent micturition
frequent micturition
urge urinary incontinence

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Bladder, Overactive
Urinary Incontinence, Urge
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Urinary Bladder Diseases
Propiverine
Tolterodine
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Urological Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014