Clinical trial NCT02485067: Clinical Study to Assess the Efficacy and Safety of THVD-201 in Patients With OAB
Official title: Multicenter, Randomized, Double-blind, Parallel, Active Control, Phase III Clinical Study to Assess the Efficacy and Safety of THVD-201 in Patients With Overactive Bladder Including an Open-label, Extension Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Overactive Bladder
Keywords: Overactive Bladder
Tolterodine (Detrusitol)
Pilocarpine
Lead sponsor: SK Chemicals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-06-30
Enrollment: 384
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to assess the efficacy and safety of THVD-201(Combination of tolterodine and pilocarpine) in patients with Overactive bladder during the period of treatment, 12 weeks.

This study also includes an open label extension period of an additional 12 weeks following the treatment to assess long-term efficacy and safety of THVD-201 in patients with Overactive bladder.


Eligibility criteria: Inclusion Criteria:

* 20 - 85 years
* History of OAB (pure urge or mixed urinary incontinence with predominant urge incontinence) for ≥ 6 months.
* In the case of females, at least 2 years has passed since menopause. Or all pre-menopausal female subjects must have been using a highly effective method of birth control during the study. Subject of childbearing potential must have had a negative pregnancy test prior to enrollment.

Exclusion Criteria:

* Predominate stress incontinence, insensate incontinence (those incapable of distinguishing discrete incontinence episodes) and overflow incontinence, as major reason for urine loss or urinary frequency as determined by the investigator.
* History of neurogenic bladder.
* PVR \> 200mL
* History of clinically significant renal disease or estimated creatinine clearance defined by Cockcroft and Gault formula \< 30 mL/min.
* History of malignant tumor within the past 5 years.
* History or presence of tachyarrhythmia or cardiac disease that in the opinion of the investigator might have confounded the results of the study or posed additional risk to the subject. Subjects who had a value for QTc \> 450 msec at the Screening visit.
* Patient with asthma
* PSA ≥ 10 ng/mL in male who is 50 years and over.

Primary outcomes:
measure: Mean daily micturition frequency
timeFrame: 12 weeks
measure: ADR Incidence of Dry mouth
timeFrame: 12 weeks
Secondary outcomes:
measure: Mean daily micturition frequency
timeFrame: 24 weeks
measure: Mean daily Incontinence frequency(12 weeks)
timeFrame: 12 weeks
measure: Mean daily Incontinence frequency(24 weeks)
timeFrame: 24 weeks
measure: Mean daily Urgency frequency(12 weeks)
timeFrame: 12 weeks
measure: Mean daily Urgency frequency(24 weeks)
timeFrame: 24 weeks
measure: Mean daily Nocturia frequency(12 weeks)
timeFrame: 12 weeks
measure: Mean daily Nocturia frequency(24 weeks)
timeFrame: 24 weeks
measure: Mean daily Micturition volume(12 weeks)
timeFrame: 12 weeks
measure: Mean daily Micturition volume(24 weeks)
timeFrame: 24 weeks
measure: Score of OAB-SS questionnaire(12 weeks)
timeFrame: 12 weeks
measure: Score of OAB-SS questionnaire(24 weeks)
timeFrame: 24 weeks
measure: Score of OAB-q questionnaire(12 weeks)
timeFrame: 12 weeks
measure: Score of OAB-q questionnaire(24 weeks)
timeFrame: 24 weeks
measure: VAS score of dry mouth symptom(12 weeks)
timeFrame: 12 weeks
measure: VAS score of dry mouth symptom(24 weeks)
timeFrame: 24 weeks
measure: Score of Xerostomia Inventory questionnaire(12 weeks)
timeFrame: 12 weeks
measure: Score of Xerostomia Inventory questionnaire(24 weeks)
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital
city: Cheonan
country: Korea, Republic of
facility: Dankook University Hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Pusan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Seongnam
country: Korea, Republic of
facility: Bundang Cha Medical center
city: Seoul
country: Korea, Republic of
facility: Ajou University Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Cheil General Hospital
city: Seoul
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Bucheon ST. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul ST. Mary's Hospital
Study officials:
affiliation: Samsung Medical Center (SMC)
name: Kyu Sung Lee
role: PRINCIPAL_INVESTIGATOR
References: