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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01868516
Recruitment Status : Completed
First Posted : June 4, 2013
Last Update Posted : June 3, 2015
Sponsor:
Information provided by (Responsible Party):
Targacept Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Overactive Bladder Drug: dexmecamylamine Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1635 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : May 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
One tablet of placebo to be administered orally twice a day.
Drug: Placebo
Experimental: 0.5 mg dexmecamylamine (TC-5214)
One tablet of 0.5 mg dexmecamylamine to be administered orally twice a day.
Drug: dexmecamylamine
Other Name: TC-5214

Experimental: 1 mg dexmecamylamine (TC-5214)
One tablet of 1 mg dexmecamylamine to be administered orally twice a day.
Drug: dexmecamylamine
Other Name: TC-5214

Experimental: 2 mg dexmecamylamine (TC-5214)
One tablet of 2 mg dexmecamylamine to be administered orally twice a day.
Drug: dexmecamylamine
Other Name: TC-5214




Primary Outcome Measures :
  1. Change from baseline in micturition frequency per 24 hours [ Time Frame: 12 weeks ]
    Micturition: Any voiding episode recorded by the patient as "urinated" either with or without incontinence.

  2. Change from baseline in urinary urge incontinence (UUI) episodes per 24 hours [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Change from baseline in the volume voided per micturition [ Time Frame: 12 weeks ]
  2. Change from baseline in nocturia per 24 hours [ Time Frame: 12 weeks ]
    Nocturia: A micturition that wakes the subject from sleep between the time the subject went to bed and the time the subject woke up.

  3. Clinical Global Impression of Improvement (CGI-I) [ Time Frame: 12 weeks ]
  4. Change from baseline in Patient Perception of Bladder Condition (PPBC) [ Time Frame: 12 weeks ]
  5. Change from baseline in the Urgency Questionnaire [ Time Frame: 12 weeks ]
  6. Change from baseline in disease specific quality of life (OABq) [ Time Frame: 12 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01868516


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Sponsors and Collaborators
Targacept Inc.

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Responsible Party: Targacept Inc.
ClinicalTrials.gov Identifier: NCT01868516     History of Changes
Other Study ID Numbers: TC-5214-23-CRD-003
First Posted: June 4, 2013    Key Record Dates
Last Update Posted: June 3, 2015
Last Verified: August 2014

Additional relevant MeSH terms:
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Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms