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

Spinal Cord Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00800462
• Other study ID #: 2007-SCI-M3-488
• Status: Completed
• Phase: Phase 4
• First received: December 1, 2008
• Last updated: April 4, 2013
• Start date: March 2008
• Est. completion date: December 2012

Study information

• Verified date: April 2013
• Source: Toronto Rehabilitation Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: December 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. 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.

2. 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.]

3. Patients with serum creatinine within normal limits and normal renal function

4. Patients on a stable dose (minimum one month) of concomitant medication for Neurogenic detrusor overactivity

5. Patients must have adequate cognitive function to understand the requirements of the study, including completing questionnaires and signing a written Informed Consent.

Exclusion Criteria:

1. 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.

2. Patients with a history of transurethral sphincterotomy, bladder neck or prostatic resection, previous bladder surgery including myomectomy or augmentation cystoplasty.

3. Patients with chronic indwelling catheters.

4. Patients with, in the opinion of the Investigator, unstable or stable multiple sclerosis.

5. Patients with known, uncontrolled systemic disease.

6. Patients with evidence of recent alcohol/drug abuse.

7. Patients with urinary retention, gastrointestinal obstructive disorders or uncontrolled narrow-angle glaucoma.

8. Patients with contraindications to Trosec™, Enablex™ and Uromax®.

9. 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.

10. Patients with a history of poor cooperation, non-compliance, or unreliability.

11. Patients currently participating in an investigational drug study or who have participated in an investigational drug study within 30 days of the Screening Visit.

12. Patients administered anticholinergics and/or antispasmodic drugs during the course of the study.

13. Patient with hepatic insufficiency.

14. 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.

15. Patient has any medical condition that would interfere with the interpretation of the study results or the conduct of the study.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neurogenic Detrusor Overactivity
• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

Drug:
• Oxybutynin Cl
15 mg qd for 3 months
• Trospium Cl
20mg bid for 3 months
• Darifenacin Hydrogen Bromide (HBr)
15 mg qd for 3 months

Locations

Country	Name	City	State
Canada	Toronto Rehabilitation Institute, Lyndhurst Centre	Toronto	Ontario
Canada	University of Manitoba, Health Sciences Centre	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
Toronto Rehabilitation Institute	Ontario Neurotrauma Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of Incontinence Episodes		3 days	No
Primary	Adverse Event Reporting		Each Study Visit and Follow-up Phone Call	Yes
Secondary	Urodynamic Study		Baseline and 3 months	Yes
Secondary	Questionnaires		Monthly	No

External Links

•   Ontario Neurotrauma Foundation