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

NCT00332319 | Terminated Phase 2

• 1 other identifier: NKB104846
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 3

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.

Conditions

Incontinence, Urinary and Urinary Bladder, Overactive; Overactive Bladder

Keywords

spinal cord injury; urgency; Overactive bladder; neurogenic; neurometry; frequency; urge incontinence

Outcome Measures

Primary Outcomes (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 Outcomes (1)

• Improvement of OAB symptoms (incontinence, frequency of urination, reduction in urgency, decrease in night-time urination episodes).

Interventions

GW679769 DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (3)

GSK Investigational Site

Long Beach, California, 90806, United States

Location

GSK Investigational Site

Cleveland, Ohio, 44195, United States

Location

GSK Investigational Site

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive; Spinal Cord Injuries; Urinary Incontinence, Urge

Interventions

casopitant

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Urinary Incontinence; Urination Disorders

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2006
• First Posted: June 1, 2006
• Study Start: January 1, 2006
• Primary Completion: February 1, 2007
• Study Completion: February 1, 2007
• Last Updated: April 17, 2015

Record last verified: 2011-03

Locations

US (3)