Extended-Release Oxybutynin for the Treatment of Neurogenic Detrusor Overactivity

NCT01796548 | Terminated Phase 4 Results DMC

• 2 other identifiers: CR015205R016446OAB4011
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to evaluate the effects and tolerability (how well a participant can stand a particular medicine or treatment) of flexible dose Oxybutynin Extended-Release (OXY-ER, Lyrinel) including safety and quality of life assessment in participants with neurogenic detrusor overactivity (NDO - the nerves mediating the detrusor muscle do not work properly leading to frequent feeling of need to urinate during the day, night, or both).

Conditions

Detrusor Function, Overactive

Keywords

Detrusor function, overactive; Urinary incontinence; Oxybutynin; Lyrinel

Outcome Measures

Primary Outcomes (1)

• Maximal Detrusor Pressure

  Maximal detrusor pressure represents the maximum pressure (peak amplitude) in the bladder during the first involuntary contraction of the bladder muscle. Detrusor pressure is the component of intravesical (in the bladder) pressure that is created by forces in the bladder wall (passive and active). It was estimated by subtracting abdominal pressure from intravesical pressure.

  Week 12

Secondary Outcomes (8)

• Maximal Cystometric Capacity (MCC)

  Baseline and Week 12

• Detrusor Leakpoint Pressure

  Baseline and Week 12

• Post-Void Residual Urine Volume

  Baseline and Week 12

• Reflex Volume

  Baseline and Week 12

• Urge Incontinence Episodes

  Baseline, Week 4 and Week 12

Study Arms (1)

Oxybutynin Extended-Release

EXPERIMENTAL

Oxybutynin chloride 5, 10, 15 milligram (mg) per tablet 10-30 mg per day orally

Drug: Oxybutinin Extended-Release

Interventions

Oxybutinin Extended-Release DRUG

Oxybutynin chloride 5, 10, 15 milligram (mg) per tablet 10-30 mg per day orally

Also known as: Lyrinel

Oxybutynin Extended-Release

Eligibility Criteria

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

You may qualify if:

• Diagnosis of overactive bladder as a result of neurogenic condition, for example following spinal cord injury, multiple sclerosis (slowly worsening disorder of the central nervous system that causes symptoms such as weakness, incoordination, numbness, problems talking and problems seeing), Parkinson's disease (a progressive disorder of the central nervous system, seen usually in older persons, in which there is slow movement \[due to muscle weakness\], trembling and sweating), or cerebrovascular accidents (CVAs - stroke-sudden loss of blood supply to brain)
• Women must not be pregnant and be of either non-childbearing potential or is using adequate means of birth control
• Overactive bladder symptoms and/or has urge incontinence episodes
• Must have normal results on urine culture tests and on urinalysis
• ECOG (Eastern Cooperative Oncology Group) performance status score of less than or equal to 3

You may not qualify if:

• Participants with 1 or more treatable or conditions, other than neurogenic bladder dysfunction, that may cause urinary incontinence or urgency
• Any medical or unstable condition that precludes their participation in the study or may confound the outcome of the study (participants with or at risk for urinary retention, gastric retention or uncontrolled narrow angle; heart failure or kidney failure; diabetes mellitus; abnormal muscle weakness \[myasthenia gravis\]; paralysis or inactivity in the intestines that prevents material moving through the gut \[intestinal atony or paralytic ileus\]; severe inflammation of the bowel \[ulcerative colitis\] sudden expansion of the large intestine seen in advanced ulcerative colitis or Crohn's disease \[toxic megacolon\]; history of major lower urinary tract surgery \[transurethral resection will be excluded\])
• Hypersensitivity to the investigational drug or any of its ingredients (eg, lactose)
• Pregnant or breast feeding female
• Significant bacteriuria (presence of bacteria in the urine) or pyuria (presence of white blood cells) in the urine

Sponsors & Collaborators

• Janssen-Cilag Ltd.,Thailand: lead

Study Sites (3)

Unknown Facility

Bangkok, Thailand

Location

Unknown Facility

Chiang Mai, Thailand

Location

Unknown Facility

Phathumwan, Thailand

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Incontinence

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; Urination Disorders

Results Point of Contact

• Title: Medical Affairs Director
• Organization: Medical Affairs, Janssen-Cilag (Thailand)

662-792-7200

Study Officials

• Janssen-Cilag Ltd.,Thailand Clinical trial

  Janssen-Cilag Ltd.,Thailand

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2013
• First Posted: February 21, 2013
• Study Start: December 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: November 26, 2013
• Results First Posted: July 31, 2013

Record last verified: 2013-10

Locations

TH (3)