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

Overactive Bladder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02485067
• Other study ID #: THVD-201_OAB_III_2014
• Status: Completed
• Phase: Phase 3
• First received: June 12, 2015
• Last updated: January 11, 2017
• Start date: January 2015
• Est. completion date: September 2016

Study information

• Verified date: January 2017
• Source: SK Chemicals Co.,Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 384
• Est. completion date: September 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Drug:
• THVD-201
Combination of Tolterodine 2mg and Pilocarpine 9mg
• Placebo(For THVD-201)

• Detrusitol 2mg tablet
Tolterodine 2mg
• Placebo(For Detrusitol 2mg tablet)

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
SK Chemicals Co.,Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean daily micturition frequency	The change of Mean daily micturition frequency between 0 and 12 weeks	12 weeks	No
Primary	ADR Incidence of Dry mouth		12 weeks	Yes
Secondary	Mean daily micturition frequency	The change of Mean daily micturition frequency between 0 and 24 weeks	24 weeks	No
Secondary	Mean daily Incontinence frequency(12 weeks)	The change of Mean daily Incontinence frequency between 0 and 12 weeks	12 weeks	No
Secondary	Mean daily Incontinence frequency(24 weeks)	The change of Mean daily Incontinence frequency between 0 and 24 weeks	24 weeks	No
Secondary	Mean daily Urgency frequency(12 weeks)	The change of Mean daily Urgency frequency between 0 and 12 weeks	12 weeks	No
Secondary	Mean daily Urgency frequency(24 weeks)	The change of Mean daily Urgency frequency between 0 and 24 weeks	24 weeks	No
Secondary	Mean daily Nocturia frequency(12 weeks)	The change of Mean daily Nocturia frequency between 0 and 12 weeks	12 weeks	No
Secondary	Mean daily Nocturia frequency(24 weeks)	The change of Mean daily Nocturia frequency between 0 and 24 weeks	24 weeks	No
Secondary	Mean daily Micturition volume(12 weeks)	The change of Mean daily Micturition volume between 0 and 12 weeks	12 weeks	No
Secondary	Mean daily Micturition volume(24 weeks)	The change of Mean daily Micturition volume between 0 and 24 weeks	24 weeks	No
Secondary	Score of OAB-SS questionnaire(12 weeks)	The change of the Score between 0 and 12 weeks	12 weeks	No
Secondary	Score of OAB-SS questionnaire(24 weeks)	The change of the Score between 0 and 24 weeks	24 weeks	No
Secondary	Score of OAB-q questionnaire(12 weeks)	The change of the Score between 0 and 12 weeks	12 weeks	No
Secondary	Score of OAB-q questionnaire(24 weeks)	The change of the Score between 0 and 24 weeks	24 weeks	No
Secondary	VAS score of dry mouth symptom(12 weeks)	The change of the Score between 0 and 12 weeks	12 weeks	No
Secondary	VAS score of dry mouth symptom(24 weeks)	The change of the Score between 0 and 24 weeks	24 weeks	No
Secondary	Score of Xerostomia Inventory questionnaire(12 weeks)	The change of the Score between 0 and 12 weeks	12 weeks	No
Secondary	Score of Xerostomia Inventory questionnaire(24 weeks)	The change of the Score between 0 and 24 weeks	24 weeks	No