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

Urinary Bladder, Overactive Clinical Trial

Official title:

The Efficacy of Oxybutynin Chloride OROS in Patient-Reported Outcomes With Dose Escalation in Korean Overactive Bladder Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00613327
• Other study ID #: CR013840
• Secondary ID: OXY-KOR-4001
• Status: Completed
• Phase: Phase 4
• First received: January 31, 2008
• Last updated: October 24, 2013
• Start date: September 2007
• Est. completion date: June 2008

Study information

• Verified date: October 2013
• Source: Janssen Korea, Ltd., Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

This is a multicenter (when more than one hospital or medical school team work on a medical research study), open-label (all people know the identity of the intervention), prospective (study following participants forward in time) Phase 4 study of oxybutynin chloride OROS in participants with overactive bladder. The total study duration will be 12 weeks and will include following visits: Screening (Week -2), Baseline, Week 2, 4, 6 and 12. 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. Efficacy will primarily be evaluated by assessment of goal achievement (percentage of participants who show a score 4 or 5 in the Likert scale for treatment goal) at Week 12. Participants' safety will also be monitored at each visit.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 345
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Urinary Bladder, Overactive

Intervention

Drug:
• Oxybutynin chloride OROS
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Korea, Ltd., Korea

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Urinary Urgency at Week 12	Participants assessed their bothering for overactive bladder symptom by completing POSQ rated on a 5-point scale: how much they were bothered by urinary urgency (strong micturition desire indicated) in the past two weeks. The responses were indicated as: 1 (not bothered at all), 2 (slightly bothered), 3 (average), 4 (strongly bothered) and 5 (very strongly bothered). Number of participants with change from Baseline in the response to this question at Week 12 was reported.	Baseline and Week 12	No
Secondary	Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Frequent Daytime Urination at Week 12	Participants assessed their bothering for overactive bladder symptom by completing POSQ rated on a 5-point scale: how much they were bothered by daytime frequent urination (frequent urination was required more than the frequency desired during daytime) in the past two weeks. The responses were indicated as: 1 (not bothered at all), 2 (slightly bothered), 3 (average), 4 (strongly bothered) and 5 (very strongly bothered). Number of participants with change from Baseline in the response to this question at Week 12 was reported.	Baseline and Week 12	No
Secondary	Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Frequent Nighttime Urination at Week 12	Participants assessed their bothering for overactive bladder symptom by completing POSQ rated on a 5-point scale: how much they were bothered by nighttime frequent urination (waking up from sleep in order to void urine at nighttime [period from time of going to bed to time planned to wake up in the morning]) in the past two weeks. The responses were indicated as: 1 (not bothered at all), 2 (slightly bothered), 3 (average), 4 (strongly bothered) and 5 (very strongly bothered). Number of participants with change from Baseline in the response to this question at Week 12 was reported.	Baseline and Week 12	No
Secondary	Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Urge Urinary Incontinence at Week 12	Participants assessed their bothering for overactive bladder symptom by completing POSQ rated on a 5-point scale: how much they were bothered by urge urinary incontinence (involuntary voiding or urinary leakage due to sudden micturition desire, not by sneezing, coughing or laughing) in the past two weeks. The responses were indicated as: 1 (not bothered at all), 2 (slightly bothered), 3 (average), 4 (strongly bothered) and 5 (very strongly bothered). Number of participants with change from Baseline in the response to this question at Week 12 was reported.	Baseline and Week 12	No
Secondary	Patient's Perception of Symptom Improvement (PPSI) Score for Overactive Bladder	Participant's perception about decrease in the most bothering symptom of overactive bladder (defined at Baseline) was evaluated by using visual analogue scale (VAS) at Week 12. The total score range was 0 to 100 where 0=symptom disappeared and 100=symptom unchanged or worsened compared to Baseline.	Week 12	No
Secondary	Number of Participants With Response to Patient's Perception of Treatment Benefit (PPTB) Questionnaire	The PPTB was used to assess participant's perception about treatment benefit and satisfaction of the study drug. Regarding benefit, participants indicated whether they had any benefit obtained from the treatment. If yes, then the participants indicated whether it was weak benefit or strong benefit. Regarding satisfaction, participants indicated whether they were satisfied with the treatment. If yes, then they indicated if the treatment was slightly satisfactory or very satisfactory. If no, then they indicated if the treatment was slightly unsatisfactory or very unsatisfactory.	Week 2, 4, 6 and 12	No
Secondary	Number of Participants With Response to Patient's Perception of Bladder Condition (PPBC) Questionnaire	Participant's perception about bladder condition was evaluated by using self administered PPBC questionnaire. Participants answered "Which of the following statements describes your bladder condition best at the moment?" on a 6-point scale: 1= not problematic at all, 2=mild problem, 3=more or less a mild problem, 4=moderate problem, 5=severe problem and 6=very severe problem.	Baseline and Week 12	No
Secondary	Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Score at Week 6 and 12	The OAB-q was used to evaluate influence of overactive bladder symptom on health-related quality of life (HRQL). It consisted of 2 parts: Symptom bother (6 items) evaluating how much symptoms related to overactive bladder were bothering in the last 4 weeks and HRQL (13 items) evaluating how general symptoms related to the bladder influenced life in the last 4 weeks. Each item was rated on 6-point Likert scale: 1 (not at all) to 6 (a very great deal). Total score range: 6 to 36 for symptom bother and 13 to 78 for HRQL. Transformed score calculated as ([Actual total raw score - lowest possible value of raw score]/range)*100 for symptom bother where higher score indicates greater symptom bother and as ([Highest possible raw score-Actual total raw score]/Raw score range)*100 for HRQL where higher scores indicate better HRQL. Transformed score range: 0-100 for both, symptom bother and HRQL.	Baseline, Week 6, 12 or early discontinuation (ED)	No
Secondary	Mean Voiding Frequency	Mean voiding frequency for 24 hours was calculated as sum of total voiding frequency divided by the number of days when micturition chart was completed. Participants completed micturition chart for 3 days at Baseline, Week 6 and 12/ED. Mean daytime voiding frequency for 24 hours was calculated as sum of total daytime voiding frequency divided by the number of days when micturition chart was completed. Mean nighttime voiding frequency for 24 hours was calculated as sum of total nighttime voiding frequency divided by the number of days when micturition chart was completed. Nighttime voiding was defined as voiding during the sleep cycle.	Baseline, Week 6, 12 or ED	No
Secondary	Percent Change From Baseline in Mean Voiding Frequency at Week 6 and 12	Mean voiding frequency for 24 hours was calculated as sum of total voiding frequency divided by the number of days when micturition chart was completed. Participants completed micturition chart for 3 days at Baseline, Week 6 and 12/ED. Mean daytime voiding frequency for 24 hours was calculated as sum of total daytime voiding frequency divided by the number of days when micturition chart was completed. Mean nighttime voiding frequency for 24 hours was calculated as sum of total nighttime voiding frequency divided by the number of days when micturition chart was completed. Nighttime voiding was defined as voiding during the sleep cycle. Percent change was calculated as (change value/Baseline value)*100.	Baseline, Week 6, 12 or ED	No
Secondary	Frequency of Urinary Urgency and Urinary Incontinence	Urinary urgency means sudden and strong urge to urinate. It was rated by participant on 5-point scale (1=no urinary urgency and 5=urge urinary incontinence). Total frequency of urinary incontinence (UI) for 24 hours was calculated as sum of total frequency of incontinence divided by the number of days when micturition chart was completed. Participants completed micturition chart for 3 days at Baseline, Week 6 and 12/ED. Mean frequency of urinary urgency for 24 hours was calculated as sum of total frequency of urinary urgency divided by the number of days when micturition chart was completed. Urinary urgency was defined as voiding with urinary sensation scale score greater than or equal to 3.	Baseline, Week 6, 12 or ED	No
Secondary	Percent Change From Baseline in Frequency of Urinary Urgency and Urinary Incontinence at Week 6 and 12	Urinary urgency means sudden and strong urge to urinate. It was rated by participant on 5-point scale (1=no urinary urgency and 5=urge urinary incontinence). Total frequency of UI for 24 hours was calculated as sum of total frequency of incontinence divided by the number of days when micturition chart was completed. Participants completed micturition chart for 3 days at Baseline, Week 6 and 12/ED. Mean frequency of urinary urgency for 24 hours was calculated as sum of total frequency of urinary urgency divided by the number of days when micturition chart was completed. Urinary urgency was defined as voiding with urinary sensation scale score greater than or equal to 3. Percent change was calculated as (change value/Baseline value)*100.	Baseline, Week 6, 12 or ED	No
Secondary	Mean Severity of Urinary Urgency at Urination	Urinary urgency means sudden and strong urge to urinate. It was rated by participant on 5-point scale (1=no urinary urgency, 2=light urinary urgency, 3=moderate urinary urgency, 4=severe urinary urgency and 5=urge urinary incontinence). Mean severity of urinary urgency at urination was calculated as sum of all degrees of urinary urgency measured divided by the voiding frequency.	Baseline, Week 6, 12 or ED	No
Secondary	Visual Analogue Scale (VAS) Score for Dry Mouth	Severity of dry mouth was evaluated in participants by using VAS: how much dry mouth they have experienced in the past one week. The total score range was 0 (no dry mouth) to 100 (unimaginably most severe dry mouth).	Baseline, Week 6, 12 or ED	Yes
Secondary	Percent Change From Baseline in Visual Analogue Scale (VAS) Score for Dry Mouth at Week 6 and 12	Severity of dry mouth was evaluated in participants by using VAS: how much dry mouth they experienced in the past one week. The total score range was 0 (no dry mouth) to 100 (unimaginably most severe dry mouth). Percent change was calculated as (change value/Baseline value)*100.	Baseline, Week 6, 12 or ED	Yes