Clinical Study to Assess the Efficacy and Safety of THVD-201 in Patients With OAB
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
1 other identifier
interventional
384
1 country
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2015
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 12, 2015
CompletedFirst Posted
Study publicly available on registry
June 30, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedJanuary 12, 2017
January 1, 2017
1.5 years
June 12, 2015
January 11, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Mean daily micturition frequency
The change of Mean daily micturition frequency between 0 and 12 weeks
12 weeks
ADR Incidence of Dry mouth
12 weeks
Secondary Outcomes (17)
Mean daily micturition frequency
24 weeks
Mean daily Incontinence frequency(12 weeks)
12 weeks
Mean daily Incontinence frequency(24 weeks)
24 weeks
Mean daily Urgency frequency(12 weeks)
12 weeks
Mean daily Urgency frequency(24 weeks)
24 weeks
- +12 more secondary outcomes
Study Arms (2)
THVD-201
EXPERIMENTAL1\. Treatment period(12 weeks) 1. Double dummy(A+B) A. THVD-201: capsule B. Placebo(For Detrusitol 2mg tablet) 2. One capsule and One tablet bid on an empty stomach 2\. Open-label extension period(An additional 12 weeks) 1. Regardless of the previous type of arm, all patients only take THVD-201 during this period. 2. One capsule bid on an empty stomach
Tolterodine (Detrusitol)
ACTIVE COMPARATOR1\. Treatment period(12 weeks) 1. Double dummy(A+B) A. Placebo(For THVD-201): capsule B. Detrusitol 2mg tablet 2. One capsule and One tablet bid on an empty stomach 2\. Open-label extension period(An additional 12 weeks) 1. Regardless of the previous type of arm , all patients only take THVD-201 during this period. 2. One capsule bid on an empty stomach
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Inje University Busan Paik Hospital
Busan, South Korea
Dankook University Hospital
Cheonan, South Korea
Chonnam National University Hospital
Gwangju, South Korea
Pusan National University Hospital
Pusan, South Korea
Bundang Cha Medical center
Seongnam, South Korea
Ajou University Medical Center
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
Cheil General Hospital
Seoul, South Korea
Gachon University Gil Medical Center
Seoul, South Korea
Konkuk University Medical Center
Seoul, South Korea
Korea University Anam Hospital
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Severance Hospital
Seoul, South Korea
The Catholic University of Korea, Bucheon ST. Mary's Hospital
Seoul, South Korea
The Catholic University of Korea, Seoul ST. Mary's Hospital
Seoul, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kyu Sung Lee
Samsung Medical Center (SMC)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2015
First Posted
June 30, 2015
Study Start
January 1, 2015
Primary Completion
July 1, 2016
Study Completion
September 1, 2016
Last Updated
January 12, 2017
Record last verified: 2017-01