Last updated: 11/04/2018 09:39:52

Effects Of GW679769 On Bladder Nerve Function And Symptoms Of Overactive Bladder In Spinal Cord Injury Patients

GSK study ID
NKB104846
See study documents
Clinicaltrials.gov ID
NCT00332319
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A randomized, double-blind, placebo-controlled, crossover study (Part 1) and parallel group design study (Part 2) to evaluate the effects of GW679769 on Current Perception Threshold (CPT) following a single dose and the effect on CPT and symptoms of overactive bladder (OAB) following 28 days of repeat dosing in Patients with Neurogenic Bladder due to Upper Motor Neuron (UMN) Disease
Trial description: This is a two-part study in which Part A will assess the effects of GW679769 after 1 dose on the function of the nerves that supply the bladder. The technique for measuring the nerves function is called Neurometry. Part B will assess the effect of repeat doses of GW679769 on the bladder nerve function. Part B will also assess the effects of the drug on overactive bladder symptoms using a three-day patient diary.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:

Part A: Change in post dose current perception threshold (CPT) value of C-fibers from pre-dose CPT value after a single dose of 150 mg GW679769 and after placebo

Timeframe: Up to Day 14

Part B: Change in post dose CPT value of C-fibers from pre-dose CPT value following 28 days of repeat dosing of 120 mg GW679769 and after placebo

Timeframe: Up to Day 43

Secondary outcomes:

Part A: Number of participants with adverse events (AEs) and serious adverse events (SAEs) following a single dose of 150 mg GW679769

Timeframe: Up to Day 14

Part A: Number of participants with clinical safety data (potential clinical concern) from 12-Lead electrocardiogram (ECG) following a single dose of 150 mg GW679769

Timeframe: Up to Day 14

Part A: Number of participants with clinical safety data (potential cinical concern) from vital signs following a single dose of 150 mg and 28 days repeat dosing of 120 mg GW679769

Timeframe: Up to Day 14

Part A: Number of participants with potential clinical importance data for hematology following a single dose of 150 mg GW679769

Timeframe: Up to Day 14

Part A: Number of participants with potential clinical importance data for clinical chemistry following a single dose of 150 mg GW679769

Timeframe: Up to Day 14

Part A: Post void residual urinary volume following a single dose of 150 mg GW679769

Timeframe: Up to Day 14

Part A: Change in post dose CPT value of A-delta fibers from pre-dose CPT value after a single dose of 150 mg of GW679769 and placebo

Timeframe: Up to Day 14

Part A: Change in post dose CPT value of A-beta fibers from pre-dose CPT value after a single dose of 150 mg of GW679769 and placebo

Timeframe: Up to Day 14

Part A: The effect of a single dose of 150 mg of GW679769 on sleepiness as assessed using the Stanford Sleepiness Scale

Timeframe: Up to Day 7

Part B: Number of participants with AEs and SAEs following a 28 days repeat dosing of 120 mg GW679769

Timeframe: Up to follow-up visit (approximately up to Day 50)

Part B: Number of participants with clinical safety data (potential clinical concern) from 12-Lead ECG following a 28 days repeat dosing of 120 mg GW679769

Timeframe: Up to follow-up visit (approximately up to Day 50)

Part B: Number of participants with clinical safety data (potential clinical concern) from vital signs following a 28 days repeat dosing of 120 mg GW679769

Timeframe: Up to follow-up visit (approximately up to Day 50)

Part B: Number of participants with potential clinical importance data for hematology following a 28 days repeat dosing of 120 mg GW679769

Timeframe: Up to follow-up visit (approximately up to Day 50)

Part B: Number of participants with potential clinical importance data for clinical chemistry following a 28 days repeat dosing of 120 mg GW679769

Timeframe: Up to follow-up visit (approximately up to Day 50)

Part B: Post void residual urinary volume following a single dose of 150 mg and 28 days repeat dosing of 120 mg GW679769

Timeframe: Up to Day 42

Part B: Change from pre dose value to 28 day value after repeat dosing of 120 mg of GW679769 in CPT A-delta fibers and CPT A-beta fibers

Timeframe: Up to Day 43

Part B: Change from pre-dose value to 28 day value after repeat dosing of 120 mg of GW679769 in incontinence episodes/24 hours

Timeframe: Up to Day 42

Part B: Change from pre-dose value to 28 day value after repeat dosing of 120 mg of GW679769 in micturitions or intermittent catherizations (based on sensation to void) /24 hours

Timeframe: Up to Day 42

Part B: Change from predose value to 28 day value after repeat dosing of 120 mg of GW679769 in urgency episodes/24 hours and nocturia episodes/24 hours

Timeframe: Up to Day 42

Part B: Change from pre-dose value to 28 day value after repeat dosing of 120 mg of GW679769 in volume voided/micturition or catherization

Timeframe: Up to Day 43

Part B: Change from pre-dose value to 28 day value after repeat dosing of 120 mg of GW679769 in maximum volume voided

Timeframe: Up to Day 43

Part B: The effect of repeat dosing of 120 mg of GW679769 on sleepiness

Timeframe: Up to Day 43

Interventions:
  • Drug: GW679769 150 mg
  • Drug: GW679769 150 mg placebo
  • Drug: GW679769 120 mg
  • Drug: GW679769 120 mg placebo
  • Drug: Lidocaine
    • Enrollment:
    3
    Primary completion date:
    2007-09-02
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Incontinence, Urinary and Urinary Bladder, Overactive
    Product
    casopitant
    Collaborators
    Not applicable
    Study date(s)
    January 2006 to February 2007
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 65 years
    Accepts healthy volunteers
    No
    • Inclusion criteria:
    • Spinal cord injury patients with overactive bladder symptoms including urge incontinence, urgency, frequency and night-time urination but without bladder related pain.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • Spinal cord injury patients with overactive bladder symptoms including urge incontinence, urgency, frequency and night-time urination but without bladder related pain.
    • The injury must be above S1-3 Exclusion criteria:
    • Spinal cord injury suffered within 6 months.
    • History of interstitial cystitis, radiation cystitis, pelvic irradiation, or myocardial infarction with 1 year prior to screening.
    • Pregnant or nursing females.
    • Patients who have had hypersensitivity to lidocaine.
    • Patients who are taking oral corticosteroids.
    • Patients with active peptic ulcer disease (PUD) and/or history of PUD of an unknown etiology.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Cleveland, Ohio, United States, 44195
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Philadelphia, Pennsylvania, United States, 19107
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Long Beach, California, United States, 90806
    Status
    Study Complete
    Contact us

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Other
    Actual primary completion date
    2007-09-02
    Actual study completion date
    2007-09-02

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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