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

This study has been completed.
Sponsor:
Collaborator:
Ontario Neurotrauma Foundation
Information provided by (Responsible Party):
Magdy Hassouna, Toronto Rehabilitation Institute
ClinicalTrials.gov Identifier:
NCT00800462
First received: December 1, 2008
Last updated: April 4, 2013
Last verified: April 2013

December 1, 2008
April 4, 2013
March 2008
June 2012   (final data collection date for primary outcome measure)
  • Frequency of Incontinence Episodes [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • Adverse Event Reporting [ Time Frame: Each Study Visit and Follow-up Phone Call ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00800462 on ClinicalTrials.gov Archive Site
  • Urodynamic Study [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: Yes ]
  • Questionnaires [ Time Frame: Monthly ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Comparative Study of the Efficacy and Safety of Muscarinic M3 Receptors Antagonists in the Treatment of Neurogenic Detrusor Overactivity
Comparative Study of the Efficacy and Safety of Muscarinic M3 Receptors Antagonists in the Treatment of Neurogenic Detrusor Overactivity

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Spinal Cord Injury
  • Neurogenic Detrusor Overactivity
  • Drug: Oxybutynin Cl
    15 mg qd for 3 months
    Other Name: Uromax
  • Drug: Trospium Cl
    20mg bid for 3 months
    Other Name: Trosec
  • Drug: Darifenacin Hydrogen Bromide (HBr)
    15 mg qd for 3 months
    Other Name: Enablex
  • Active Comparator: Oxybutynin Cl
    Intervention: Drug: Oxybutynin Cl
  • Active Comparator: Trospium Cl
    Intervention: Drug: Trospium Cl
  • Active Comparator: Darifenacin Hydrogren Bromide (HBr)
    Intervention: Drug: Darifenacin Hydrogen Bromide (HBr)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
23
December 2012
June 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00800462
2007-SCI-M3-488
No
Magdy Hassouna, Toronto Rehabilitation Institute
Toronto Rehabilitation Institute
Ontario Neurotrauma Foundation
Principal Investigator: Magdy Hassouna, MD Toronto Rehabilitation Institute
Toronto Rehabilitation Institute
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP