An Efficacy and Safety Study of Oxybutynin Chloride Oral Osmotic Therapeutic System (OROS) in Korean Overactive Bladder Participants

NCT00613327 | Completed Phase 4 Results

• 2 other identifiers: CR013840OXY-KOR-4001
• Study Type: interventional
• Target: 345
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this study is to evaluate the efficacy of oxybutynin chloride oral osmotic therapeutic system (OROS) on patient-reported outcomes after 12 weeks of treatment by dose escalation in participants with overactive bladder.

Conditions

Urinary Bladder, Overactive

Keywords

Overactive bladder; Oxybutynin chloride; OROS

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Achieved Treatment Goal

  Goal achievement was measured by using the 6-point Likert scale (0=not achieved at all and 5=completely achieved). Achievement of treatment goal was defined by a score of 4 or 5 in the Likert scale. Percentage of participants who achieved their treatment goal defined at Baseline (for a maximum of 3 items among the 10 items including incontinence, urinary urgency, frequent urination, nocturnal frequent urination, tenesmus, general health, life habit, activity, pain/pressure pain, and sexual function) was reported.

  Week 12

Secondary Outcomes (15)

• Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Urinary Urgency at Week 12

  Baseline and Week 12

• Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Frequent Daytime Urination at Week 12

  Baseline and Week 12

• Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Frequent Nighttime Urination at Week 12

  Baseline and Week 12

• Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Urge Urinary Incontinence at Week 12

  Baseline and Week 12

• Patient's Perception of Symptom Improvement (PPSI) Score for Overactive Bladder

  Week 12

Study Arms (1)

Oxybutynin Chloride OROS

EXPERIMENTAL

Drug: Oxybutynin chloride OROS

Interventions

Oxybutynin chloride OROS DRUG

Participants will receive oxybutynin chloride OROS tablet at starting dose of 10 milligram (mg) orally once daily. The dose will be adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks will be continued up to Week 12. Maximum allowed dose will be 30 mg per day.

Also known as: Lyrinel

Oxybutynin Chloride OROS

Eligibility Criteria

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

You may qualify if:

• Participants who fulfilled all of the following criteria in their micturition charts completed for 3 days prior to visit 2 (Baseline): mean voiding frequency greater than or equal to 8 times per 24 hours and mean frequency of urinary urgency greater than or equal to 2 times per 24 hours (urgency means sudden and strong urge to urinate and a urinary sensation scale score greater than or equal to 3 in the micturition chart)
• Participants with overactive bladder symptoms lasting for 3 months or longer prior to study initiation
• Participants who were capable of completing micturition chart and survey questionnaires and provided informed consent to complete them
• Participants who could sign on the informed consent form after fully listening to and understanding about characteristics, risks and benefits of the study

You may not qualify if:

• Participants with stress urinary incontinence (not able to control bladder actions) or participants with complicated incontinence dominantly presenting stress urinary incontinence when judging based on medical history
• Participants with a hepatic (pertaining to liver) or renal (pertaining to kidneys) disease indicating serum aspartate transaminase (AST \[SGOT\]), alanine transaminase (ALT \[SGPT\]), alkaline phosphatase or creatinnine concentration twice or more of normal upper limit
• Participants contraindicated to use anticholinergics including uncontrolled narrow angle glaucoma (increased pressure inside the eye that causes visual problems), urinary retention or gastrointestinal tract retention
• Participants experiencing a symptom of acute urinary tract infection (UTI) during the run-in period
• Participants with recurrent UTI who had medical history of treatment for UTI symptom 5 times or more in the past one year

Sponsors & Collaborators

• Janssen Korea, Ltd., Korea: lead

MeSH Terms

Conditions

Urinary Bladder, Overactive

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

Results Point of Contact

• Title: Clinical Research Associate
• Organization: Medical Affairs, Janssen Korea

+82-2-2094-4935

Study Officials

• Janssen Korea, Ltd. Clinical Trial

  Janssen Korea, Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2008
• First Posted: February 13, 2008
• Study Start: September 1, 2007
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: November 19, 2013
• Results First Posted: September 16, 2013

Record last verified: 2013-10