Clinical Study to Assess the Efficacy and Safety of THVD-201 in Patients With OAB

NCT ID: NCT02485067

Last Updated: 2017-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 384 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2016-09-30

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.

Conditions

Overactive Bladder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

THVD-201

1. 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

Group Type: EXPERIMENTAL

THVD-201

Intervention Type: DRUG

Combination of Tolterodine 2mg and Pilocarpine 9mg

Placebo(For Detrusitol 2mg tablet)

Intervention Type: DRUG

Tolterodine (Detrusitol)

1. 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

Group Type: ACTIVE_COMPARATOR

THVD-201

Intervention Type: DRUG

Combination of Tolterodine 2mg and Pilocarpine 9mg

Placebo(For THVD-201)

Intervention Type: DRUG

Detrusitol 2mg tablet

Intervention Type: DRUG

Tolterodine 2mg

Interventions

THVD-201

Combination of Tolterodine 2mg and Pilocarpine 9mg

Intervention Type: DRUG

Placebo(For THVD-201)

Intervention Type: DRUG

Detrusitol 2mg tablet

Tolterodine 2mg

Intervention Type: DRUG

Placebo(For Detrusitol 2mg tablet)

Intervention Type: DRUG

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SK Chemicals Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kyu Sung Lee

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center (SMC)

Locations

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

Countries

South Korea

Other Identifiers

THVD-201_OAB_III_2014

Identifier Type: -

Identifier Source: org_study_id