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

NCT ID: NCT00800462

Last Updated: 2013-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2012-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Oxybutynin Cl

Group Type: ACTIVE_COMPARATOR

Oxybutynin Cl

Intervention Type: DRUG

15 mg qd for 3 months

Trospium Cl

Group Type: ACTIVE_COMPARATOR

Trospium Cl

Intervention Type: DRUG

20mg bid for 3 months

Darifenacin Hydrogren Bromide (HBr)

Group Type: ACTIVE_COMPARATOR

Darifenacin Hydrogen Bromide (HBr)

Intervention Type: DRUG

15 mg qd for 3 months

Interventions

Oxybutynin Cl

15 mg qd for 3 months

Intervention Type: DRUG

Trospium Cl

20mg bid for 3 months

Intervention Type: DRUG

Darifenacin Hydrogen Bromide (HBr)

15 mg qd for 3 months

Intervention Type: DRUG

Other Intervention Names

Uromax; Trosec; Enablex

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ontario Neurotrauma Foundation

OTHER

Sponsor Role: collaborator

Toronto Rehabilitation Institute

OTHER

Sponsor Role: lead

Responsible Party

Magdy Hassouna

MD PhD FRCSC FACS

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Magdy Hassouna, MD

Role: PRINCIPAL_INVESTIGATOR

Toronto Rehabilitation Institute

Locations

University of Manitoba, Health Sciences Centre

Winnipeg, Manitoba, Canada

Toronto Rehabilitation Institute, Lyndhurst Centre

Toronto, Ontario, Canada

Countries

Canada

Related Links

http://www.onf.org

Ontario Neurotrauma Foundation

Other Identifiers

2007-SCI-M3-488

Identifier Type: -

Identifier Source: org_study_id