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

Information source: SK Chemicals Co.,Ltd.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Overactive Bladder

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

Phase: Phase 3

Status: Recruiting

Sponsored by: SK Chemicals Co.,Ltd.

Official(s) and/or principal investigator(s):
Kyu Sung Lee, Principal Investigator, Affiliation: Samsung Medical Center (SMC)

Overall contact:
Eun Ha Kim, Phone: +82-2-2008-2571, Email: eunha@sk.com

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.

Clinical Details

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

Primary outcome:

Mean daily micturition frequency

ADR Incidence of Dry mouth

Secondary outcome:

Mean daily micturition frequency

Mean daily Incontinence frequency(12 weeks)

Mean daily Incontinence frequency(24 weeks)

Mean daily Urgency frequency(12 weeks)

Mean daily Urgency frequency(24 weeks)

Mean daily Nocturia frequency(12 weeks)

Mean daily Nocturia frequency(24 weeks)

Mean daily Micturition volume(12 weeks)

Mean daily Micturition volume(24 weeks)

Score of OAB-SS questionnaire(12 weeks)

Score of OAB-SS questionnaire(24 weeks)

Score of OAB-q questionnaire(12 weeks)

Score of OAB-q questionnaire(24 weeks)

VAS score of dry mouth symptom(12 weeks)

VAS score of dry mouth symptom(24 weeks)

Score of Xerostomia Inventory questionnaire(12 weeks)

Score of Xerostomia Inventory questionnaire(24 weeks)

Eligibility

Minimum age: 20 Years. Maximum age: 85 Years. Gender(s): Both.

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.

Locations and Contacts

Eun Ha Kim, Phone: +82-2-2008-2571, Email: eunha@sk.com

Inje University Busan Paik Hospital, Busan, Korea, Republic of; Recruiting

Dankook University Hospital, Cheonan, Korea, Republic of; Recruiting

Chonnam National University Hospital, Gwangju, Korea, Republic of; Recruiting

Pusan National University Hospital, Pusan, Korea, Republic of; Recruiting

Bundang Cha Medical center, Seongnam, Korea, Republic of; Recruiting

Ajou University Medical Center, Seoul, Korea, Republic of; Recruiting

Asan Medical Center, Seoul, Korea, Republic of; Recruiting

Cheil General Hospital, Seoul, Korea, Republic of; Recruiting

Gachon University Gil Medical Center, Seoul, Korea, Republic of; Recruiting

Konkuk University Medical Center, Seoul, Korea, Republic of; Recruiting

Korea University Anam Hospital, Seoul, Korea, Republic of; Recruiting

Samsung Medical Center, Seoul, Korea, Republic of; Recruiting

Seoul National University Hospital, Seoul, Korea, Republic of; Recruiting

Severance Hospital, Seoul, Korea, Republic of; Recruiting

The Catholic University of Korea, Bucheon ST. Mary's Hospital, Seoul, Korea, Republic of; Recruiting

The Catholic University of Korea, Seoul ST. Mary's Hospital, Seoul, Korea, Republic of; Recruiting

Additional Information

Starting date: January 2015
Last updated: June 25, 2015

Page last updated: August 23, 2015

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