Propiverine Hydrochloride Extended-Release Capsule for Overactive Bladder
This study has been completed.
Sponsor:
Lee's Pharmaceutical Limited
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
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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:
|
|
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 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 Incontinence, Urge Urinary Bladder, Overactive Urination Disorders Urologic Diseases Urological Manifestations Signs and Symptoms Urinary Bladder Diseases Propiverine Tolterodine |
Parasympatholytics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Muscarinic Antagonists |
ClinicalTrials.gov processed this record on May 22, 2013