Propiverine Hydrochloride Extended-Release Capsule for Overactive Bladder

Overactive Bladder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01512004
• Other study ID #: LEES-MIC
• Status: Completed
• Phase: Phase 3
• First received: November 24, 2010
• Last updated: January 24, 2012
• Start date: January 2010
• Est. completion date: August 2011

Study information

• Verified date: January 2012
• Source: Lee's Pharmaceutical Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 324
• Est. completion date: August 2011
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive
• Urinary Incontinence
• Urinary Incontinence, Urge

Intervention

Drug:
• Propiverine Hydrochloride
drug of oral capsule
• Tolterodine Extended-release Tablet
4mg/tablet; oral; once per day

Locations

Country	Name	City	State
China	Beijing Chaoyang Hospital	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Lee's Pharmaceutical Limited	APOGEPHA Arzneimittel GmbH

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alteration of mean micturition frequency within 24h on the basis of continuous 3-day record	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	prior to medication and 8 weeks after medication	Yes
Secondary	The alteration of mean incontinence frequency and mean micturition frequency and volume within 24 hours on the basis of continuous 3-day record	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.	prior to medication, 2 weeks and 8 weeks after medication	Yes