Status:
COMPLETED
Comparative Study of the Efficacy and Safety of Muscarinic M3 Receptors Antagonists in the Treatment of Neurogenic Detrusor Overactivity
Lead Sponsor:
Toronto Rehabilitation Institute
Collaborating Sponsors:
Ontario Neurotrauma Foundation
Conditions:
Spinal Cord Injury
Neurogenic Detrusor Overactivity
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
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 dr...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00800462
Start Date
March 1 2008
End Date
December 1 2012
Last Update
April 8 2013
Active Locations (2)
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1
University of Manitoba, Health Sciences Centre
Winnipeg, Manitoba, Canada, R3A1R9
2
Toronto Rehabilitation Institute, Lyndhurst Centre
Toronto, Ontario, Canada, M4G 3V9