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Exploratory Study Evaluating the Effects of Darifenacin on Nocturia, Sleep and Daytime Wakefulness

Primary Purpose

Nocturia

Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
darifenacin
Placebo
Sponsored by
Cognitive Research Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional trial for Nocturia

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subject must be aged 21-70, inclusive.
  • Subject mush have given written, personally signed and dated informed consent.
  • Subject must be diagnosed with overactive bladder.
  • Subject must have a nocturia frequency of greater than or equal to 3 episodes a night.
  • Subject must be male or non-pregnant, non-lactating female who agrees to comply with applicable contraceptive requirements.
  • Subject understands and is able, will a nd and likely to fully comply with study procedures and restrictions.

Exclusion Criteria:

  • Subject has any concurrent chronic or acute illness or unstable medical condition either treated or untreated that could confound the results of safety assessments, increase risk to the subject or lead to difficulty complying with the protocol.
  • The subject has a known or suspected allergy, hypersensitivity, or other medical contraindications to darifenacin (Enablex®) (or its components).
  • The subject has concomitant diseases in which the use of anticholinergic drugs is contraindicated, e.g. urinary retention, bladder obstruction, gastric retention and other severe decreased gastrointestinal motility conditions, uncontrolled narrow-angle glaucoma, myasthenia gravis, severe hepatic impairment (Child Pugh C), severe ulcerative colitis, toxic megacolon, and patients who are at risk for these conditions.
  • Subject is taking another drug which is considered to have significant anticholinergic activity.
  • Use of drugs known to effect cognition, alertness or drowsiness, such as benzodiazepines, sedating antihistamines, opioids, or other sedative hypnotic drugs.
  • Subject has moderate to severe obstructive sleep apnea (Apnea/Hypopnea Index ≥ 15)
  • Subject has a medical condition other than OAB that is the most likely cause of the subject's nocturia (e.g., primary sleep disorder, polydipsia, polyuria).
  • Subject has taken another investigational drug or taken part in a clinical trial within the last 30 days prior to Screening.
  • The female subject is pregnant or lactating.
  • Subjects with a urine drug screen positive for stimulants, barbiturates, hallucinogens, opiates, cocaine, cannabis, or amphetamines

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    darifenacin

    Sugar Pill

    Arm Description

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    November 20, 2009
    Last Updated
    April 12, 2016
    Sponsor
    Cognitive Research Corporation
    Collaborators
    Novartis Pharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01018225
    Brief Title
    Exploratory Study Evaluating the Effects of Darifenacin on Nocturia, Sleep and Daytime Wakefulness
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2016
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Study was cancelled due to lack of enrollment
    Study Start Date
    November 2009 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    July 2010 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Cognitive Research Corporation
    Collaborators
    Novartis Pharmaceuticals

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the efficacy of darifenacin in the treatment of moderate to severe nocturia in patients with overactive bladder and who do not have non-urologic causes of nocturia.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Nocturia

    7. Study Design

    Study Phase
    Phase 4
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    darifenacin
    Arm Type
    Experimental
    Arm Title
    Sugar Pill
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    darifenacin
    Other Intervention Name(s)
    Enablex
    Intervention Description
    7.5 or 15 mg darifenacin, once a day for 6 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo pill, once a day, for six weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subject must be aged 21-70, inclusive. Subject mush have given written, personally signed and dated informed consent. Subject must be diagnosed with overactive bladder. Subject must have a nocturia frequency of greater than or equal to 3 episodes a night. Subject must be male or non-pregnant, non-lactating female who agrees to comply with applicable contraceptive requirements. Subject understands and is able, will a nd and likely to fully comply with study procedures and restrictions. Exclusion Criteria: Subject has any concurrent chronic or acute illness or unstable medical condition either treated or untreated that could confound the results of safety assessments, increase risk to the subject or lead to difficulty complying with the protocol. The subject has a known or suspected allergy, hypersensitivity, or other medical contraindications to darifenacin (Enablex®) (or its components). The subject has concomitant diseases in which the use of anticholinergic drugs is contraindicated, e.g. urinary retention, bladder obstruction, gastric retention and other severe decreased gastrointestinal motility conditions, uncontrolled narrow-angle glaucoma, myasthenia gravis, severe hepatic impairment (Child Pugh C), severe ulcerative colitis, toxic megacolon, and patients who are at risk for these conditions. Subject is taking another drug which is considered to have significant anticholinergic activity. Use of drugs known to effect cognition, alertness or drowsiness, such as benzodiazepines, sedating antihistamines, opioids, or other sedative hypnotic drugs. Subject has moderate to severe obstructive sleep apnea (Apnea/Hypopnea Index ≥ 15) Subject has a medical condition other than OAB that is the most likely cause of the subject's nocturia (e.g., primary sleep disorder, polydipsia, polyuria). Subject has taken another investigational drug or taken part in a clinical trial within the last 30 days prior to Screening. The female subject is pregnant or lactating. Subjects with a urine drug screen positive for stimulants, barbiturates, hallucinogens, opiates, cocaine, cannabis, or amphetamines

    12. IPD Sharing Statement

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    Exploratory Study Evaluating the Effects of Darifenacin on Nocturia, Sleep and Daytime Wakefulness

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