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

Information source: Janssen Korea, Ltd., Korea
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Urinary Bladder, Overactive

Intervention: Oxybutynin chloride OROS (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Janssen Korea, Ltd., Korea

Official(s) and/or principal investigator(s):
Janssen Korea, Ltd. Clinical Trial, Study Director, Affiliation: Janssen Korea, Ltd.

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.

Clinical Details

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

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

Primary outcome: Percentage of Participants Who Achieved Treatment Goal

Secondary outcome:

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

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

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

Number of Participants With Response to Patient's Perception of Treatment Benefit (PPTB) Questionnaire

Number of Participants With Response to Patient's Perception of Bladder Condition (PPBC) Questionnaire

Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Score at Week 6 and 12

Mean Voiding Frequency

Percent Change From Baseline in Mean Voiding Frequency at Week 6 and 12

Frequency of Urinary Urgency and Urinary Incontinence

Percent Change From Baseline in Frequency of Urinary Urgency and Urinary Incontinence at Week 6 and 12

Mean Severity of Urinary Urgency at Urination

Visual Analogue Scale (VAS) Score for Dry Mouth

Percent Change From Baseline in Visual Analogue Scale (VAS) Score for Dry Mouth at Week 6 and 12

Detailed 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Additional Information

Starting date: September 2007
Last updated: October 24, 2013

Page last updated: August 23, 2015

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