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

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.

Study Overview

• Status: Completed
• Conditions: Overactive Bladder
• Intervention / Treatment: Drug: THVD-201; Drug: Placebo(For Detrusitol 2mg tablet); Drug: Placebo(For THVD-201); Drug: Detrusitol 2mg tablet

• Study Type: Interventional
• Enrollment (Actual): 384
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of
    • Inje University Busan Paik Hospital
  • Cheonan, Korea, Republic of
    • Dankook University Hospital
  • Gwangju, Korea, Republic of
    • Chonnam National University Hospital
  • Pusan, Korea, Republic of
    • Pusan National University Hospital
  • Seongnam, Korea, Republic of
    • Bundang Cha Medical Center
  • Seoul, Korea, Republic of
    • Seoul National University Hospital
  • Seoul, Korea, Republic of
    • Asan Medical Center
  • Seoul, Korea, Republic of
    • Konkuk University Medical Center
  • Seoul, Korea, Republic of
    • Samsung Medical Center
  • Seoul, Korea, Republic of
    • Severance Hospital
  • Seoul, Korea, Republic of
    • Korea University Anam Hospital
  • Seoul, Korea, Republic of
    • The Catholic University of Korea, Seoul St. Mary's Hospital
  • Seoul, Korea, Republic of
    • Gachon University Gil Medical Center
  • Seoul, Korea, Republic of
    • Cheil General Hospital
  • Seoul, Korea, Republic of
    • Ajou University Medical Center
  • Seoul, Korea, Republic of
    • The Catholic University of Korea, Bucheon St. Mary's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: THVD-201; 1. Treatment period(12 weeks); Double dummy(A+B) A. THVD-201: capsule B. Placebo(For Detrusitol 2mg tablet); One capsule and One tablet bid on an empty stomach 2. Open-label extension period(An additional 12 weeks); Regardless of the previous type of arm, all patients only take THVD-201 during this period.; One capsule bid on an empty stomach	Drug: THVD-201; Combination of Tolterodine 2mg and Pilocarpine 9mg; Drug: Placebo(For Detrusitol 2mg tablet)
Active Comparator: Tolterodine (Detrusitol); 1. Treatment period(12 weeks); Double dummy(A+B) A. Placebo(For THVD-201): capsule B. Detrusitol 2mg tablet; One capsule and One tablet bid on an empty stomach 2. Open-label extension period(An additional 12 weeks); Regardless of the previous type of arm , all patients only take THVD-201 during this period.; One capsule bid on an empty stomach	Drug: THVD-201; Combination of Tolterodine 2mg and Pilocarpine 9mg; Drug: Placebo(For THVD-201); Drug: Detrusitol 2mg tablet; Tolterodine 2mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean daily micturition frequency	The change of Mean daily micturition frequency between 0 and 24 weeks	24 weeks
Mean daily Incontinence frequency(12 weeks)	The change of Mean daily Incontinence frequency between 0 and 12 weeks	12 weeks
Mean daily Incontinence frequency(24 weeks)	The change of Mean daily Incontinence frequency between 0 and 24 weeks	24 weeks
Mean daily Urgency frequency(12 weeks)	The change of Mean daily Urgency frequency between 0 and 12 weeks	12 weeks
Mean daily Urgency frequency(24 weeks)	The change of Mean daily Urgency frequency between 0 and 24 weeks	24 weeks
Mean daily Nocturia frequency(12 weeks)	The change of Mean daily Nocturia frequency between 0 and 12 weeks	12 weeks
Mean daily Nocturia frequency(24 weeks)	The change of Mean daily Nocturia frequency between 0 and 24 weeks	24 weeks
Mean daily Micturition volume(12 weeks)	The change of Mean daily Micturition volume between 0 and 12 weeks	12 weeks
Mean daily Micturition volume(24 weeks)	The change of Mean daily Micturition volume between 0 and 24 weeks	24 weeks
Score of OAB-SS questionnaire(12 weeks)	The change of the Score between 0 and 12 weeks	12 weeks
Score of OAB-SS questionnaire(24 weeks)	The change of the Score between 0 and 24 weeks	24 weeks
Score of OAB-q questionnaire(12 weeks)	The change of the Score between 0 and 12 weeks	12 weeks
Score of OAB-q questionnaire(24 weeks)	The change of the Score between 0 and 24 weeks	24 weeks
VAS score of dry mouth symptom(12 weeks)	The change of the Score between 0 and 12 weeks	12 weeks
VAS score of dry mouth symptom(24 weeks)	The change of the Score between 0 and 24 weeks	24 weeks
Score of Xerostomia Inventory questionnaire(12 weeks)	The change of the Score between 0 and 12 weeks	12 weeks
Score of Xerostomia Inventory questionnaire(24 weeks)	The change of the Score between 0 and 24 weeks	24 weeks

Collaborators and Investigators

• Sponsor: SK Chemicals Co., Ltd.
• Investigators: Principal Investigator: Kyu Sung Lee, Samsung Medical Center (SMC)

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: June 12, 2015
• First Submitted That Met QC Criteria: June 25, 2015
• First Posted (Estimate): June 30, 2015

Study Record Updates

• Last Update Posted (Estimate): January 12, 2017
• Last Update Submitted That Met QC Criteria: January 11, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Overactive Bladder; Pilocarpine; Tolterodine (Detrusitol)
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Urological Agents; Tolterodine Tartrate
• Other Study ID Numbers: THVD-201_OAB_III_2014