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

Janssen (J&J Innovative Medicine)

Status and phase

Completed

Phase 4

Conditions

Urinary Bladder, Overactive

Treatments

Drug: Oxybutynin chloride OROS

Study type

Interventional

Funder types

Industry

Identifiers

NCT00613327

OXY-KOR-4001

CR013840

Details and patient eligibility

About

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.

Full 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.

Enrollment

345 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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