We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: NCT00332319
Recruitment Status : Terminated
First Posted : June 1, 2006
Last Update Posted : April 17, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Incontinence, Urinary and Urinary Bladder, Overactive Overactive Bladder Drug: GW679769 Phase 2

Detailed Description:
A randomized, double-blind, placebo-controlled study to evaluate the effects of GW679769 on Current Perception Threshold (CPT) following a single 150 mg dose (Part A) and to evaluate the effect of CPT and symptoms of overactive bladder following 28 days of repeat dosing with 120 mg GW679769 administered once daily (Part B) in patients with neurogenic bladder due to incomplete spinal cord injury

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: See Detailed Description
Study Start Date : January 2006
Primary Completion Date : February 2007
Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Change in bladder nerve activity assessed by neurometry before and after a single dose of GW679769 and placebo (part A) and after 28 days of drug or placebo treatment (part B).

Secondary Outcome Measures :
  1. Improvement of OAB symptoms (incontinence, frequency of urination, reduction in urgency, decrease in night-time urination episodes).

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

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): NCT00332319


Locations
United States, California
GSK Investigational Site
Long Beach, California, United States, 90806
United States, Ohio
GSK Investigational Site
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00332319     History of Changes
Other Study ID Numbers: NKB104846
First Posted: June 1, 2006    Key Record Dates
Last Update Posted: April 17, 2015
Last Verified: March 2011

Keywords provided by GlaxoSmithKline:
spinal cord injury
urgency
Overactive bladder
neurogenic
neurometry
frequency
urge incontinence

Additional relevant MeSH terms:
Spinal Cord Injuries
Urinary Bladder, Overactive
Urinary Incontinence
Enuresis
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Urination Disorders
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Casopitant
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Neurokinin-1 Receptor Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action