Official Title: “The Effectiveness of Oxybutynin Chloride OROS in Patient-Reported Outcomes With Dose Escalation in Korean Overactive Bladder Patients”

The objective of this study is to investigate the effectiveness of oxybutynin chloride OROS on patient-reported outcomes after 12 weeks of treatment through the increasing of dosage levels for overactive bladder (OAB) patients

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study

Traditionally, the success of treatment for OAB was measured in terms of patient-perceived levels of cure, improvements of symptoms, number of urination episodes over 24 hours, reduction of incontinence episodes, and side effects. Urodynamic measures on bladder function include urination amount at the time of initial contraction, maximum capacity of the bladder, and the amount of residual urine. Traditional symptomatic and urodynamic measures of successful treatment may be meaningful for doctors, but normally these did not deal with what was important for patients. Therefore, it is necessary to assess Patient-Reported Outcomes (PROs) to provide subjective outcomes of measurements on patients' reactions to the treatment. For diseases like overactive bladder, for which symptoms are already well defined, PROs can be the best way to observe treatment. If the treatment actually improves the symptoms and if such improvements positively affect the health-related quality of life of the patients. Overactive bladder can be defined by several different symptoms but not all patients experience all of them. Some may have only one whereas others may have differing combinations of them. Similarly, the severity of the symptoms differ among different patients. Therefore, evaluating symptom-specific PROs for different treatment regimens may provide valuable information for the treatment of OAB. The patient begins treatment with a 10mg dose of oxybutynin chloride OROS daily. The dose will be controlled in 10mg units based on the Optimal Dose Evaluation Criteria. Dosage changes will be conducted over six weeks at two week intervals, until the optimal dose is achieved. Treatment will continue for an additional six weeks with the optimal dose.

Initially, patient takes 10mg a day and then, the dose will be adjusted by 10mg two-week interval according to Optimal Dose Evaluation Criteria. Maximum daily dose is 30mg.

Intervention(s) in this Clinical Trial

• Drug: Oxybutinine

Primary Measures

• Evaluating the 'Achievement of the Treatment Goal' after 12 weeks of treatment with 10-30mgs doses, according to the reactions of OAB patents.

Secondary Measures

• Evaluating patient-recorded outcomes for items, including treatment satisfaction, variables of micturition chart, (frequency of urgent urination, reduction of seriousness of symptoms, reduction of incontinence episodes, and urination events)

Inclusion Criteria:

• Patients who fulfilled all of the following criteria in their micturition charts for the 3 days prior to the 2nd visit (Baseline): Average Urination Frequency ≥ 8 times / 24 hours, Average Frequency of Urgent Urination ≥ 2 times / 24 hours (Definition of Urgent Urination: That of a Urination Sensation Scale score ≥ 3 on the micturition chart)
• Patients who had over 3 months of OAB symptoms prior to the commencement of the trial
• Patients who were capable of, and agreed to, recording a micturition chart and some questionnaires
• Patients who understood the potential risks and benefits of the trial sufficiently, after listening to an explanation of it, and who are capable of signing the Trial
• Agreement

Exclusion Criteria:

• Patients with Stress Urinary Incontinence (SUI) or patients with Mixed Urinary
• Incontinence (MUI), of which SUI was the superior part, assessed in terms of the past disease history of the patient
• Patients whose creatinine or the following liver enzyme concentrations were at least 2 times the upper limit of normal: aspartate aminotransferase (AST [SGOT]), alanine aminotransferase (ALT [SGPT]), and alkaline phosphatase
• Patients suffering from kidney disease
• Patients who were prohibited from taking anti-cholinergics due to symptoms of uncontrolled narrow angle glaucoma, urinary retention, or gastric retention
• Patients who had urinary tract infections (UTI) during the run-in period
• Patients with recurrent UTI, and who were treated on 5 occasions or more during the past year due to these UTI symptoms
• Patients who had been diagnosed with, or assumed to have, Interstitial Cystitis (IC)
• Patients with significant Bladder Outlet Obstruction found in clinical trials or with lower urinary tract functions, determined by the researcher according to clinical symptoms and treatment standards
• Patients who had had prostate surgery / intervention, (including minimal invasive therapy), or with a history of surgery on major sections of the urethra and/or the bladder. (Patients who had had an SUI operation more than 6 months prior to the trial were not excluded from the clinical trial.)
• Male patients over 50 years old who were found to have 10ng/ml or more serum prostate specific antigen (PSA) levels, had past disease histories, or were assumed to presently have prostate cancer
• Patients with a history of radiotherapy to their pelvic organs or external genitals, (external or epileptic), regardless of the reasons
• Patients who exhibited lower urinary tract neuropathological symptoms of multiple sclerosis (MS), Parkinson's disease, or spinal cord damage
• Patients with notable cystocele or clinically significant pelvic organ prolapse
• Patients who had a history of malignant tumors, including bladder cancer, uterine cancer, or cervical cancer in the past 2 years
• Patients expected to have the following medication during the trial period after the 1st visit (Trial Commencement): All anti-cholinergics excepting the trial doses, All treatment medications for OAB. (However, estrogen treatment begun more than 2 months prior to the start of the clinical trial was allowed)
• Patients who were taking, prior to the 1st visit (Trial Commencement), or who were expected to take medicines during the trial period, with anti-cholinergic side effects, at unstable dosage levels
• Patients who took tricyclic antidepressants (TCA), diuretic or α-blocker, but who did not take doses in a stable manner for at least 1 month prior to the 1st visit (Trial
• Commencement)
• Patients who took selective serotonin reuptake inhibitors (SSRI) but who did not take doses in a stable manner for at least 3 month prior to the 1st visit (Trial
• Commencement). (This means that patients who took SSRI at stable dosages were allowed to participate in the trial.)
• Patients who were scheduled for, after the 1st visit (Trial Commencement), or were expected to have, during the trial period, electrical stimulation or bladder training
• Patients who suffered had an indwelling urethral catheter or intermittent self-catheter
• Patients who were medicated under another clinical trial within 1 month prior to the 1st visit (Trial Commencement)
• Patients who had chronic constipation or a history of serious constipation
• Female patients who were pregnant or breast-feeding
• Sexually active, reproductive age female patients not using adequate contraception methods for at least 1 month prior to the start of this trial, and who were unwilling to continue to use such contraception methods during the trial period. Definite contraception methods refer to the use of intrauterine devices (IUDs), combined contraceptive pills, transdermal contraceptive systems, hypodermic transfer hormone drugs, injectable contraceptives, operative methods, (tubal ligation or vaseptomy), and abstinence
• Patients who, as ascertained by the investigator, were otherwise unsuitable for participation in this trial

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Janssen Korea, Ltd., Korea

Overall Clinical Trial Officials and Contacts

Janssen Korea, Ltd. Clinical Trial Study Director Janssen Korea, Ltd., Korea  

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00613327

Study ID Number: CR013840

ClinicalTrials.gov Identifier: NCT00613327

Health Authority: Korea: Food and Drug Administration