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

Primary Purpose

Overactive Bladder

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
THVD-201
Placebo(For THVD-201)
Detrusitol 2mg tablet
Placebo(For Detrusitol 2mg tablet)
Sponsored by
SK Chemicals Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder focused on measuring Overactive Bladder, Tolterodine (Detrusitol), Pilocarpine

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

THVD-201

Tolterodine (Detrusitol)

Arm Description

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

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

Outcomes

Primary Outcome Measures

Mean daily micturition frequency
The change of Mean daily micturition frequency between 0 and 12 weeks
ADR Incidence of Dry mouth

Secondary Outcome Measures

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

Full Information

First Posted
June 12, 2015
Last Updated
January 11, 2017
Sponsor
SK Chemicals Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02485067
Brief Title
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

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SK Chemicals Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder
Keywords
Overactive Bladder, Tolterodine (Detrusitol), Pilocarpine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
384 (Actual)

8. Arms, Groups, and Interventions

Arm Title
THVD-201
Arm Type
Experimental
Arm Description
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
Arm Title
Tolterodine (Detrusitol)
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
THVD-201
Intervention Description
Combination of Tolterodine 2mg and Pilocarpine 9mg
Intervention Type
Drug
Intervention Name(s)
Placebo(For THVD-201)
Intervention Type
Drug
Intervention Name(s)
Detrusitol 2mg tablet
Intervention Description
Tolterodine 2mg
Intervention Type
Drug
Intervention Name(s)
Placebo(For Detrusitol 2mg tablet)
Primary Outcome Measure Information:
Title
Mean daily micturition frequency
Description
The change of Mean daily micturition frequency between 0 and 12 weeks
Time Frame
12 weeks
Title
ADR Incidence of Dry mouth
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Mean daily micturition frequency
Description
The change of Mean daily micturition frequency between 0 and 24 weeks
Time Frame
24 weeks
Title
Mean daily Incontinence frequency(12 weeks)
Description
The change of Mean daily Incontinence frequency between 0 and 12 weeks
Time Frame
12 weeks
Title
Mean daily Incontinence frequency(24 weeks)
Description
The change of Mean daily Incontinence frequency between 0 and 24 weeks
Time Frame
24 weeks
Title
Mean daily Urgency frequency(12 weeks)
Description
The change of Mean daily Urgency frequency between 0 and 12 weeks
Time Frame
12 weeks
Title
Mean daily Urgency frequency(24 weeks)
Description
The change of Mean daily Urgency frequency between 0 and 24 weeks
Time Frame
24 weeks
Title
Mean daily Nocturia frequency(12 weeks)
Description
The change of Mean daily Nocturia frequency between 0 and 12 weeks
Time Frame
12 weeks
Title
Mean daily Nocturia frequency(24 weeks)
Description
The change of Mean daily Nocturia frequency between 0 and 24 weeks
Time Frame
24 weeks
Title
Mean daily Micturition volume(12 weeks)
Description
The change of Mean daily Micturition volume between 0 and 12 weeks
Time Frame
12 weeks
Title
Mean daily Micturition volume(24 weeks)
Description
The change of Mean daily Micturition volume between 0 and 24 weeks
Time Frame
24 weeks
Title
Score of OAB-SS questionnaire(12 weeks)
Description
The change of the Score between 0 and 12 weeks
Time Frame
12 weeks
Title
Score of OAB-SS questionnaire(24 weeks)
Description
The change of the Score between 0 and 24 weeks
Time Frame
24 weeks
Title
Score of OAB-q questionnaire(12 weeks)
Description
The change of the Score between 0 and 12 weeks
Time Frame
12 weeks
Title
Score of OAB-q questionnaire(24 weeks)
Description
The change of the Score between 0 and 24 weeks
Time Frame
24 weeks
Title
VAS score of dry mouth symptom(12 weeks)
Description
The change of the Score between 0 and 12 weeks
Time Frame
12 weeks
Title
VAS score of dry mouth symptom(24 weeks)
Description
The change of the Score between 0 and 24 weeks
Time Frame
24 weeks
Title
Score of Xerostomia Inventory questionnaire(12 weeks)
Description
The change of the Score between 0 and 12 weeks
Time Frame
12 weeks
Title
Score of Xerostomia Inventory questionnaire(24 weeks)
Description
The change of the Score between 0 and 24 weeks
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyu Sung Lee
Organizational Affiliation
Samsung Medical Center (SMC)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inje University Busan Paik Hospital
City
Busan
Country
Korea, Republic of
Facility Name
Dankook University Hospital
City
Cheonan
Country
Korea, Republic of
Facility Name
Chonnam National University Hospital
City
Gwangju
Country
Korea, Republic of
Facility Name
Pusan National University Hospital
City
Pusan
Country
Korea, Republic of
Facility Name
Bundang Cha Medical center
City
Seongnam
Country
Korea, Republic of
Facility Name
Ajou University Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Cheil General Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Gachon University Gil Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Konkuk University Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Severance Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Bucheon ST. Mary's Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Seoul ST. Mary's Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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