AzTrials
AzTrials

Overactive BladderPhase 2NCT01868516

Study Evaluating the Safety, Tolerability, and Efficacy of Dexmecamylamine (TC-5214) for Treatment of Overactive Bladder

A Phase 2 study testing dexmecamylamine in people with Overactive Bladder, run by Targacept Inc. at 125 sites in United States.

Completed

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

Official record
Search all trials

Trial summary

Overactive bladder (OAB) is a syndrome characterized by symptoms of a sudden need to urinate with or without incontinence (leaking). The purpose of this study is to test whether dexmecamylamine is safe and effective compared to placebo for the treatment of symptoms of OAB. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Overactive Bladder
What is being tested?
dexmecamylamine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,635 participants
Where
125 sitesUnited States
Study dates
May 2013to Jun 2014
Phase
Phase 2
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Verified medical history of overactive bladder for at least 6 months
  • Capable of walking unassisted to use the bathroom
  • Able to measure voided urine volume and complete the diary without assistance
  • If the subject is currently being treated with an OAB medication, the subject is willing to discontinue OAB medications while participating in this study

Who cannot join

  • Diagnosis of a neurological disease affecting bladder function
  • Stress incontinence, insensate incontinence, overflow incontinence or incontinence due to urinary fistula
  • History of incomplete bladder emptying, bladder outflow obstruction or post-void residual bladder volume > 150 mL
  • Males with benign prostatic hyperplasia or with a prostate-specific antigen (PSA) of 4 ng/mL or more
  • Other urinary tract pathology such as malignancy, ureteric reflux, bladder stone, uninvestigated hematuria, urethral stricture, or cystitis
  • Prior treatment with intravesical or intraprostatic botulinum toxin in the last 2 years
Show all 12Show fewer
  • Myasthenia gravis
  • Angle closure glaucoma
  • Current implantation of interstim electrodes or vaginal surgical mesh
  • Presence of a clinically significant medical condition at any time during the study
  • Presence of clinically significant abnormalities in laboratory findings, physical exam findings or vital signs
  • Participated in an investigational drug trial within 3 months of screening

Trial locations and contacts

125 sites in 1 country.

125 sites in 1 country

United States125 sites

  • The Urological Institute of Northeastern New York

    Albany, New York, 12208

  • Albuquerque Clinical Trials, Inc.

    Albuquerque, New Mexico, 87102

  • SouthWest Clinical Research

    Albuquerque, New Mexico, 87109

  • Atlanta Medical Research Institute

    Alpharetta, Georgia, 30005

  • Radiant Research, Inc.

    Anderson, South Carolina, 29621

  • Radiant Reseach, Inc.

    Atlanta, Georgia, 30342

  • Heartland Research Associates, LLC

    Augusta, Kansas, 67010

  • Tekton Research, Inc.

    Austin, Texas, 78745

  • South Florida Medical Research

    Aventura, Florida, 33180

  • Urologic Consultants of SE PA

    Bala-Cynwyd, Pennsylvania, 19004

  • Summit Medical Group

    Berkeley Heights, New Jersey, 07922

  • Comprehensive Clinical Research

    Berlin, New Jersey, 08009

  • Montana Health Research Institute, Inc.

    Billings, Montana, 59102

  • Simon-Williamson Clinic, P.C.

    Birmingham, Alabama, 35209

  • Fellows Research Alliance, Inc.

    Bluffton, South Carolina, 29910

  • Boston Clinical Trials, Inc.

    Boston, Massachusetts, 02131

  • Beacon Clinical Research, LLC

    Brockton, Massachusetts, 02301

  • Meridien Reseach

    Brooksville, Florida, 34601

  • DiscoverResearch, Inc.

    Bryan, Texas, 77802

  • Mississippi Medical Research, LLC

    Carriere, Mississippi, 39426

  • Research Across America

    Carrollton, Texas, 75010

  • Radiant Research, Inc.

    Chandler, Arizona, 85224

  • Medical Research South, LLC

    Charleston, South Carolina, 29407

  • Radiant Research, Inc.

    Chicago, Illinois, 60654

  • Radiant Research, Inc.

    Cincinnati, Ohio, 45249

  • Tampa Bay Medical Research

    Clearwater, Florida, 33761

  • Rapid Medical Research, Inc.

    Cleveland, Ohio, 44122

  • The Cleveland Clinic

    Cleveland, Ohio, 44195

  • North Idaho Urology

    Coeur d'Alene, Idaho, 83814

  • Southeast Regional Research Group

    Columbus, Georgia, 31904

  • Radiant Research, Inc.

    Columbus, Ohio, 43212

  • 3H Clinical Research Corporation

    Coral Springs, Florida, 33065

  • Meridian Clinical Research

    Dakota Dunes, South Dakota, 57049

  • Research Across America

    Dallas, Texas, 75234

  • InFocus Clinical Research

    Denver, Colorado, 80211

  • Horizons Clinical Research Center, LLC

    Denver, Colorado, 80220

  • Physician's Resource Group

    Dothan, Alabama, 36305

  • Altoona Center for Clinical Research

    Duncansville, Pennsylvania, 16635

  • Radiant Research, Inc.

    Edina, Minnesota, 55435

  • Women's Health Specialty Care

    Farmington, Connecticut, 06032

  • Advanced Urology Centers of New York

    Garden City, New York, 11530

  • Clinical Trials of Arizona, Inc.

    Glendale, Arizona, 85306

  • Family Medicine Specialists, PC

    Grand Rapids, Michigan, 49544

  • Mid Atlantic Urology Associates, LLC

    Greenbelt, Maryland, 20770

  • Clinical Investigation Specialists, Inc.

    Gurnee, Illinois, 60031

  • Palm Spring Research Institute

    Hialeah, Florida, 33012

  • The Jackson Clinic

    Jackson, Tennessee, 38305

  • First Urology PSC

    Jeffersonville, Indiana, 47130

  • Advanced Therapeutics, Inc.

    Johnson City, Tennessee, 37601

  • Beyer Research

    Kalamazoo, Michigan, 49009

  • Westside Family Medical Center, PC

    Kalamazoo, Michigan, 49009

  • Center for Pharmaceutical Research

    Kansas City, Missouri, 64114

  • Premier Medical Group of the Hudson Valley, PC

    Kingston, New York, 12401

  • American Medical Research Institute

    Kissimmee, Florida, 34741

  • Altus Research

    Lake Worth, Florida, 33461

  • Sunrise Medical Research

    Lauderdale Lakes, Florida, 33319

  • Lawrence OB-GYN Clinical Research, LLC

    Lawrenceville, New Jersey, 08648

  • Women's Clinical of Lincoln, P.C.

    Lincoln, Nebraska, 68510

  • Lynn Institute of the Ozarks

    Little Rock, Arkansas, 72205

  • Atlantic Urology Medical Group

    Long Beach, California, 90806

  • DCOL Center for Clinical Research

    Longview, Texas, 75605

  • Adam D. Karnes, MD

    Los Angeles, California, 90036

  • Bluegrass Clinical Research

    Louisville, Kentucky, 40291

  • Connecticut Clinical Research Center, LLC

    Middlebury, Connecticut, 06762

  • Five Valleys Urology

    Missoula, Montana, 59808

  • Coastal Clinical Research, Inc.

    Mobile, Alabama, 33324

  • Coastal Clinical Research, Inc

    Mobile, Alabama, 36608

  • Mobile Ob-Gyn, P.C.

    Mobile, Alabama, 36608

  • Integrity Medical Research, LLC

    Mountlake Terrace, Washington, 98043

  • Coastal Carolina Research Center

    Mt. Pleasant, South Carolina, 29464

  • Tri Valley Urology Medical Group

    Murrieta, California, 92562

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572

  • Tennesse Women's Care

    Nashville, Tennessee, 37203

  • Suncoast Clinical Research, Inc.

    New Port Richey, Florida, 34652

  • Advanced Research Institute, Inc.

    New Port Richey, Florida, 34653

  • Manhattan Medical Research Practice PLLC

    New York, New York, 10016

  • Deaconess Clinic Gateway Health Center

    Newburgh, Indiana, 47630

  • Heartland Research Associates, LLC

    Newton, Kansas, 67114

  • The Group for Women

    Norfolk, Virginia, 23502

  • Clinical Research Associates of Tidewater, Inc.

    Norfolk, Virginia, 23507

  • Quality Clinical Research, Inc.

    Omaha, Nebraska, 68114

  • Research Integrity, LLC

    Owensboro, Kentucky, 42303

  • Center for Clinical Trials, LLC

    Paramount, California, 90723

  • Clinical Research of Philadelphia, LLC

    Philadelphia, Pennsylvania, 19114

  • Beach Clinical Studies

    Phoenix, Arizona, 85051

  • Clinical Research of Central Florida

    Plant City, Florida, 33563

  • Premier Medical Group of the Hudson Valley, PC

    Poughkeepsie, New York, 12601

  • Wake Research Associates, LLC

    Raleigh, North Carolina, 27612

  • Valley Women's Clinic

    Renton, Washington, 98055

  • Rochester Clinical Research, Inc.

    Rochester, New York, 14609

  • Perimeter North Medical Research, Inc.

    Roswell, Georgia, 30076

  • William Beaumont Hospital

    Royal Oak, Michigan, 48073

  • Northern California Research

    Sacramento, California, 95821

  • Saginaw Valley Medical Reseach Group, LLC

    Saginaw, Michigan, 48604

  • Wasatch Clinical Research

    Salt Lake City, Utah, 84107

  • Quality Research Inc.

    San Antonio, Texas, 78209

  • Clinical Trials of Texas, Inc.

    San Antonio, Texas, 78229

  • Radiant Reseach, Inc.

    San Antonio, Texas, 78229

  • San Diego Sexual Medicine

    San Diego, California, 92120

  • Genesis Research

    San Diego, California, 92123

  • Fellows Research Alliance, Inc.

    Savannah, Georgia, 31406

  • Radiant Research, Inc.

    Scottsdale, Arizona, 85251

  • Seattle Women's Health, Research, Gynecology

    Seattle, Washington, 98105

  • GTC Research

    Shawnee, Kansas, 66218

  • Regional Urology, LLC

    Shreveport, Louisiana, 71106

  • Willis-Knighton Physician Network

    Shreveport, Louisiana, 71115

  • Hillcrest Clinical Research, LLC

    Simpsonville, South Carolina, 29681

  • Radiant Research, Inc.

    St Louis, Missouri, 63141

  • Lakeview Medical Research

    Summerfield, Florida, 34491

  • Southeastern Research Group, Inc.

    Tallahassee, Florida, 32308

  • Westlake Medical Research

    Thousand Oaks, California, 91360

  • Genova Clinical Research, Inc.

    Tucson, Arizona, 85704

  • Radiant Research, Inc.

    Tucson, Arizona, 85710

  • Delaware Valley Urology, LLC

    Voorhees Township, New Jersey, 08043

  • Greater Providence Clinical Research, LLC

    Warwick, Rhode Island, 02888

  • Bay State Clinical Trials, Inc.

    Watertown, Massachusetts, 02472

  • Palm Beach Research Center

    West Palm Beach, Florida, 33409

  • Advanced Clinical Concepts

    West Reading, Pennsylvania, 19611

  • Heartland Research Associates, LLC

    Wichita, Kansas, 67207

  • PMG Research of Wilmington

    Wilmington, North Carolina, 28401

  • Lyndhurst Clinical Research

    Winston-Salem, North Carolina, 27103

  • Clinical Research of Central Florida

    Winter Haven, Florida, 33880

  • Metro Urology

    Woodbury, Minnesota, 55125

  • North Georgia Clinical Research

    Woodstock, Georgia, 30189

  • Physicians' Research, Inc.

    Zanesville, Ohio, 43701

Other trials in United States

About this study

Overactive bladder (OAB) is a syndrome characterized by symptoms of a sudden need to urinate with or without incontinence (leaking). The purpose of this study is to test whether dexmecamylamine is safe and effective compared to placebo for the treatment of symptoms of OAB.

Read the detailed description

The study included a three- or five-week screening period, followed by a 12-week treatment period during which patients received either one of three doses of dexmecamylamine or placebo twice daily, randomized in a ratio of 2:1:1:1 (placebo, low dose, mid dose, high dose), with a two-week follow-up period. A total of 768 subjects with overactive bladder were randomized into the double-blind treatment period of the study.

Being tested
dexmecamylamine, Placebo
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.

  • dexmecamylamineDrug

    Also called TC-5214

  • PlaceboDrug

Study groups in NCT01868516
Study groupRoleWhat they receive
PlaceboPlacebo comparatorOne tablet of placebo to be administered orally twice a day.
Receives: Drug: Placebo
0.5 mg dexmecamylamine (TC-5214)ExperimentalOne tablet of 0.5 mg dexmecamylamine to be administered orally twice a day.
Receives: Drug: dexmecamylamine
1 mg dexmecamylamine (TC-5214)ExperimentalOne tablet of 1 mg dexmecamylamine to be administered orally twice a day.
Receives: Drug: dexmecamylamine
2 mg dexmecamylamine (TC-5214)ExperimentalOne tablet of 2 mg dexmecamylamine to be administered orally twice a day.
Receives: Drug: dexmecamylamine

What is being measured

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

  1. Change from baseline in micturition frequency per 24 hours

    Micturition: Any voiding episode recorded by the patient as "urinated" either with or without incontinence.

    Measured: 12 weeks

  2. Change from baseline in urinary urge incontinence (UUI) episodes per 24 hours

    Measured: 12 weeks

Secondary outcomes (6)

  1. Change from baseline in the volume voided per micturition

    Measured: 12 weeks

  2. Change from baseline in nocturia per 24 hours

    Nocturia: A micturition that wakes the subject from sleep between the time the subject went to bed and the time the subject woke up.

    Measured: 12 weeks

  3. Clinical Global Impression of Improvement (CGI-I)

    Measured: 12 weeks

  4. Change from baseline in Patient Perception of Bladder Condition (PPBC)

    Measured: 12 weeks

  5. Change from baseline in the Urgency Questionnaire

    Measured: 12 weeks

  6. Change from baseline in disease specific quality of life (OABq)

    Measured: 12 weeks

Timeline

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

  1. First posted4 Jun 2013 (estimated)
  2. Study startMay 2013
  3. Primary completionJun 2014
  4. Study completionJun 2014

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,635 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01868516
Sponsor's protocol ID
TC-5214-23-CRD-003
Status last verified
Aug 2014
First submitted
30 May 2013
Last updated
3 Jun 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing dexmecamylamine in people with Overactive Bladder, run by Targacept Inc. at 125 sites in United States.

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 4 inclusion and 12 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 3 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 125 sites in United States. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Change from baseline in micturition frequency per 24 hours (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 NCT01868516.

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 3 Jun 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in