Propiverine Hydrochloride Extended-Release Capsule for Overactive Bladder

NCT01512004 | Completed Phase 3 DMC

• 1 other identifier: LEES-MIC
• Study Type: interventional
• Target: 324
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Overactive Bladder

Keywords

Overactive Bladder; urgent micturition; frequent micturition; urge urinary incontinence

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• The alteration of mean incontinence frequency and mean micturition frequency and volume within 24 hours on the basis of continuous 3-day record

  prior to medication, 2 weeks and 8 weeks after medication

Study Arms (2)

Propiverine Hydrochloride Extended-Release Capsule

ACTIVE COMPARATOR

30 mg/capsule; oral; once per day

Drug: Propiverine Hydrochloride

Tolterodine Extended-release Tablet

PLACEBO COMPARATOR

4mg/tablet; oral; once per day

Drug: Tolterodine Extended-release Tablet

Interventions

Propiverine Hydrochloride DRUG

drug of oral capsule

Also known as: Mictonorm, Propierine Hydrochloride Extended-Release Capsule

Propiverine Hydrochloride Extended-Release Capsule

Tolterodine Extended-release Tablet DRUG

4mg/tablet; oral; once per day

Tolterodine Extended-release Tablet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lee's Pharmaceutical Limited: lead
• APOGEPHA Arzneimittel GmbH: collaborator

Study Sites (1)

Beijing Chaoyang Hospital

Beijing, China

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Incontinence, Urge

Interventions

propiverine

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urinary Incontinence; Urination Disorders

Study Officials

• Benjamin Li, PhD

  Lee's Pharmaceutical

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2010
• First Posted: January 19, 2012
• Study Start: January 1, 2010
• Primary Completion: January 1, 2010
• Study Completion: August 1, 2011
• Last Updated: January 25, 2012

Record last verified: 2012-01

Locations

CN (1)