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

SK chemicals

Status and phase: Completed; Phase 3

Conditions: Overactive Bladder

Treatments: Drug: Placebo(For THVD-201); Drug: Detrusitol 2mg tablet; Drug: Placebo(For Detrusitol 2mg tablet); Drug: THVD-201

Study type: Interventional

Funder types: Industry

Identifiers

NCT02485067

THVD-201_OAB_III_2014

Details and patient eligibility

About

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.

Enrollment: 384 patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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384 participants in 2 patient groups

THVD-201

Experimental group

Description:

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

Treatment:

Drug: Placebo(For Detrusitol 2mg tablet)

Drug: THVD-201

Tolterodine (Detrusitol)

Active Comparator group

Description:

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

Treatment:

Drug: Detrusitol 2mg tablet

Drug: THVD-201

Drug: Placebo(For THVD-201)