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Overactive BladderPhase 3NCT02485067

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

A Phase 3 study testing THVD-201 and Detrusitol 2mg tablet in people with Overactive Bladder, run by SK Chemicals Co., Ltd. at 16 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 20 to 85 years
Conditions the study is for
Overactive Bladder
What is being tested?
THVD-201 and Detrusitol 2mg tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
384 participants
Where
16 sitesSouth Korea
Study dates
Jan 2015to Sep 2016
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

16 sites in 1 country.

16 sites in 1 country

South Korea16 sites

  • Inje University Busan Paik Hospital

    Busan

  • Dankook University Hospital

    Cheonan

  • Chonnam National University Hospital

    Gwangju

  • Pusan National University Hospital

    Pusan

  • Bundang Cha Medical center

    Seongnam

  • Ajou University Medical Center

    Seoul

  • Asan Medical Center

    Seoul

  • Cheil General Hospital

    Seoul

  • Gachon University Gil Medical Center

    Seoul

  • Konkuk University Medical Center

    Seoul

  • Korea University Anam Hospital

    Seoul

  • Samsung Medical Center

    Seoul

  • Seoul National University Hospital

    Seoul

  • Severance Hospital

    Seoul

  • The Catholic University of Korea, Bucheon ST. Mary's Hospital

    Seoul

  • The Catholic University of Korea, Seoul ST. Mary's Hospital

    Seoul

Other trials in South Korea

About this study

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

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.

Being tested
THVD-201, Placebo(For THVD-201), Detrusitol 2mg tablet, Placebo(For Detrusitol 2mg tablet)
Keywords
Overactive Bladder, Tolterodine (Detrusitol), Pilocarpine
Medical subject headings
Urinary Bladder, Overactive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • THVD-201Drug

    Combination of Tolterodine 2mg and Pilocarpine 9mg

  • Placebo(For THVD-201)Drug

  • Detrusitol 2mg tabletDrug

    Tolterodine 2mg

  • Placebo(For Detrusitol 2mg tablet)Drug

Study groups in NCT02485067
Study groupRoleWhat they receive
THVD-201Experimental1. 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
Receives: Drug: THVD-201; Drug: Placebo(For Detrusitol 2mg tablet)
Tolterodine (Detrusitol)Active comparator1. 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
Receives: Drug: THVD-201; Drug: Placebo(For THVD-201); Drug: Detrusitol 2mg tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean daily micturition frequency

    The change of Mean daily micturition frequency between 0 and 12 weeks

    Measured: 12 weeks

  2. ADR Incidence of Dry mouth

    Measured: 12 weeks

Secondary outcomes (17)

  1. Mean daily micturition frequency

    The change of Mean daily micturition frequency between 0 and 24 weeks

    Measured: 24 weeks

  2. Mean daily Incontinence frequency(12 weeks)

    The change of Mean daily Incontinence frequency between 0 and 12 weeks

    Measured: 12 weeks

  3. Mean daily Incontinence frequency(24 weeks)

    The change of Mean daily Incontinence frequency between 0 and 24 weeks

    Measured: 24 weeks

  4. Mean daily Urgency frequency(12 weeks)

    The change of Mean daily Urgency frequency between 0 and 12 weeks

    Measured: 12 weeks

  5. Mean daily Urgency frequency(24 weeks)

    The change of Mean daily Urgency frequency between 0 and 24 weeks

    Measured: 24 weeks

  6. Mean daily Nocturia frequency(12 weeks)

    The change of Mean daily Nocturia frequency between 0 and 12 weeks

    Measured: 12 weeks

  7. Mean daily Nocturia frequency(24 weeks)

    The change of Mean daily Nocturia frequency between 0 and 24 weeks

    Measured: 24 weeks

  8. Mean daily Micturition volume(12 weeks)

    The change of Mean daily Micturition volume between 0 and 12 weeks

    Measured: 12 weeks

  9. Mean daily Micturition volume(24 weeks)

    The change of Mean daily Micturition volume between 0 and 24 weeks

    Measured: 24 weeks

  10. Score of OAB-SS questionnaire(12 weeks)

    The change of the Score between 0 and 12 weeks

    Measured: 12 weeks

  11. Score of OAB-SS questionnaire(24 weeks)

    The change of the Score between 0 and 24 weeks

    Measured: 24 weeks

  12. Score of OAB-q questionnaire(12 weeks)

    The change of the Score between 0 and 12 weeks

    Measured: 12 weeks

  13. Score of OAB-q questionnaire(24 weeks)

    The change of the Score between 0 and 24 weeks

    Measured: 24 weeks

  14. VAS score of dry mouth symptom(12 weeks)

    The change of the Score between 0 and 12 weeks

    Measured: 12 weeks

  15. VAS score of dry mouth symptom(24 weeks)

    The change of the Score between 0 and 24 weeks

    Measured: 24 weeks

  16. Score of Xerostomia Inventory questionnaire(12 weeks)

    The change of the Score between 0 and 12 weeks

    Measured: 12 weeks

  17. Score of Xerostomia Inventory questionnaire(24 weeks)

    The change of the Score between 0 and 24 weeks

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jun 2015 (estimated)
  2. Study startJan 2015
  3. Primary completionJul 2016
  4. Study completionSep 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
384 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02485067
Sponsor's protocol ID
THVD-201_OAB_III_2014
Status last verified
Jan 2017
First submitted
12 Jun 2015
Last updated
12 Jan 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing THVD-201 and Detrusitol 2mg tablet in people with Overactive Bladder, run by SK Chemicals Co., Ltd. at 16 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean daily micturition frequency (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02485067.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2017.

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