Comparative Study of the Efficacy and Safety of Muscarinic M3 Receptors Antagonists in the Treatment of Neurogenic Detrusor Overactivity

NCT00800462 | Completed Phase 4

• 1 other identifier: 2007-SCI-M3-488
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 2

Brief Summary

This is a phase IV, double-blind, multicenter, randomized trial evaluating the efficacy and safety of two M3 receptors antagonists (Trospium Chloride and Darifenacin Hydrobromide) with one standard drug (Oxybutynin Chloride) for treatment of overactive bladder in individuals with spinal cord injury.

Conditions

Spinal Cord Injury; Neurogenic Detrusor Overactivity

Outcome Measures

Primary Outcomes (2)

• Frequency of Incontinence Episodes

  3 days

• Adverse Event Reporting

  Each Study Visit and Follow-up Phone Call

Secondary Outcomes (2)

• Urodynamic Study

  Baseline and 3 months

• Questionnaires

  Monthly

Study Arms (3)

Oxybutynin Cl

ACTIVE COMPARATOR

Drug: Oxybutynin Cl

Trospium Cl

ACTIVE COMPARATOR

Drug: Trospium Cl

Darifenacin Hydrogren Bromide (HBr)

ACTIVE COMPARATOR

Drug: Darifenacin Hydrogen Bromide (HBr)

Interventions

Oxybutynin Cl DRUG

15 mg qd for 3 months

Also known as: Uromax

Oxybutynin Cl

Trospium Cl DRUG

20mg bid for 3 months

Also known as: Trosec

Trospium Cl

Darifenacin Hydrogen Bromide (HBr) DRUG

15 mg qd for 3 months

Also known as: Enablex

Darifenacin Hydrogren Bromide (HBr)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients, between 18 and 75 years of age. Female patients of childbearing potential\* must have a negative urine pregnancy test result on the day of Screening Visit and practice a reliable method of contraception\*\*
• \*A female is considered of childbearing potential unless she is:
• Postmenopausal for at least 12 months prior to study drug administration;
• Without a uterus and/or both ovaries; or
• Has been surgically sterilized for at least 6 months prior to study drug administration.
• \*\*Reliable methods of contraception include:
• Hormonal methods or intrauterine device in use at least 30 days prior to study drug administration;
• Barrier methods plus spermicidal in use at least 14 days prior to study drug administration; or
• Sexual abstinence as a lifestyle.
• Patients with a neurogenic bladder and detrusor overactivity secondary to a spinal cord injury.
• Patients with urinary incontinence (minimum of one occurrence per day) despite current treatment. \[NOTE: Bladder emptying may be accomplished with straining, intermittent catheterization (IC), spontaneous micturition or leakage episodes.\]
• Patients with serum creatinine within normal limits and normal renal function
• Patients on a stable dose (minimum one month) of concomitant medication for Neurogenic detrusor overactivity
• Patients must have adequate cognitive function to understand the requirements of the study, including completing questionnaires and signing a written Informed Consent.

You may not qualify if:

• Female patients who are pregnant (positive urine pregnancy test), planning to become pregnant during the study period, breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control.
• Patients with a history of transurethral sphincterotomy, bladder neck or prostatic resection, previous bladder surgery including myomectomy or augmentation cystoplasty.
• Patients with chronic indwelling catheters.
• Patients with, in the opinion of the Investigator, unstable or stable multiple sclerosis.
• Patients with known, uncontrolled systemic disease.
• Patients with evidence of recent alcohol/drug abuse.
• Patients with urinary retention, gastrointestinal obstructive disorders or uncontrolled narrow-angle glaucoma.
• Patients with contraindications to Trosec™, Enablex™ and Uromax®.
• Patients who, in the opinion of the Investigator, have a significant condition or situation that may put the patient at significant risk, confound the study results, or interfere significantly with the patient's participation in the study.
• Patients with a history of poor cooperation, non-compliance, or unreliability.
• Patients currently participating in an investigational drug study or who have participated in an investigational drug study within 30 days of the Screening Visit.
• Patients administered anticholinergics and/or antispasmodic drugs during the course of the study.
• Patient with hepatic insufficiency.
• Patient has been administered intravesical botulinum toxin within 6 months prior to the Screening Visit and/or is expected to receive intravesical botulinum toxin during the course of the study.
• Patient has any medical condition that would interfere with the interpretation of the study results or the conduct of the study.

Sponsors & Collaborators

• Toronto Rehabilitation Institute: lead
• Ontario Neurotrauma Foundation: collaborator

Study Sites (2)

University of Manitoba, Health Sciences Centre

Winnipeg, Manitoba, R3A1R9, Canada

Location

Toronto Rehabilitation Institute, Lyndhurst Centre

Toronto, Ontario, M4G 3V9, Canada

Location

Related Links

• Ontario Neurotrauma Foundation

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

darifenacin

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Magdy Hassouna, MD

  Toronto Rehabilitation Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD FRCSC FACS

Study Record Dates

• First Submitted: December 1, 2008
• First Posted: December 2, 2008
• Study Start: March 1, 2008
• Primary Completion: June 1, 2012
• Study Completion: December 1, 2012
• Last Updated: April 8, 2013

Record last verified: 2013-04

Locations

CA (2)