Spinal Cord InjuryPhase 4NCT00800462
Comparative Study of the Efficacy and Safety of Muscarinic M3 Receptors Antagonists in the Treatment of Neurogenic Detrusor Overactivity
A Phase 4 study testing Oxybutynin Cl, Trospium Cl and Darifenacin Hydrogen Bromide (HBr) in people with Spinal Cord Injury and Neurogenic Detrusor Overactivity, run by Toronto Rehabilitation Institute at 2 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Spinal Cord Injury, Neurogenic Detrusor Overactivity
- What is being tested?
- Oxybutynin Cl, Trospium Cl and Darifenacin Hydrogen Bromide (HBr)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 2 sitesCanada
- Study dates
- Mar 2008to Dec 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Toronto Rehabilitation Institute, Lyndhurst Centre
Toronto, Ontario, M4G 3V9
University of Manitoba, Health Sciences Centre
Winnipeg, Manitoba, R3A1R9
About this study
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.
- Being tested
- Oxybutynin Cl, Trospium Cl, Darifenacin Hydrogen Bromide (HBr)
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxybutynin ClDrug
Also called Uromax
15 mg qd for 3 months
Trospium ClDrug
Also called Trosec
20mg bid for 3 months
Darifenacin Hydrogen Bromide (HBr)Drug
Also called Enablex
15 mg qd for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Oxybutynin Cl | Active comparator | Not described Receives: Drug: Oxybutynin Cl |
| Trospium Cl | Active comparator | Not described Receives: Drug: Trospium Cl |
| Darifenacin Hydrogren Bromide (HBr) | Active comparator | Not described Receives: Drug: Darifenacin Hydrogen Bromide (HBr) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Incontinence Episodes
Measured: 3 days
Adverse Event Reporting
Measured: Each Study Visit and Follow-up Phone Call
Secondary outcomes (2)
Urodynamic Study
Measured: Baseline and 3 months
Questionnaires
Measured: Monthly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2008 (estimated)
- Study startMar 2008
- Primary completionJun 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Toronto Rehabilitation Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Neurotrauma Foundation
- Responsible party
- Principal investigator, Magdy Hassouna, Toronto Rehabilitation Institute
- Investigators
- Magdy Hassouna, MD, Principal investigator, Toronto Rehabilitation Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00800462
- Sponsor's protocol ID
- 2007-SCI-M3-488
- Status last verified
- Apr 2013
- First submitted
- 1 Dec 2008
- Last updated
- 8 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of the Efficacy and Safety of Muscarinic M3 Receptors Antagonists in the Treatment of Neurogenic Detrusor Overactivity
- ClinicalTrials.gov ID
- NCT00800462
- Acronym / sponsor ID
- 2007-SCI-M3-488
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Toronto Rehabilitation InstituteUniversity, hospital or other
- Collaborators
- Ontario Neurotrauma Foundation
- Study start
- Mar 2008
- Primary completion
- Jun 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 2 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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**
- Patients with a neurogenic bladder and detrusor overactivity secondary to a spinal cord injury.
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxybutynin ClAlso: Uromax15 mg qd for 3 months | Drug | Oxybutynin Cl |
| Trospium ClAlso: Trosec20mg bid for 3 months | Drug | Trospium Cl |
| Darifenacin Hydrogen Bromide (HBr)Also: Enablex15 mg qd for 3 months | Drug | Darifenacin Hydrogren Bromide (HBr) |
Primary outcome
Frequency of Incontinence Episodes
Time frame: 3 days
Adverse Event Reporting
Time frame: Each Study Visit and Follow-up Phone Call
2 secondary outcomes
Urodynamic Study
Time frame: Baseline and 3 months
Questionnaires
Time frame: Monthly
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2013.
- Ontario Neurotrauma FoundationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Magdy Hassouna, MD principal investigator
Toronto Rehabilitation Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oxybutynin Cl, Trospium Cl and Darifenacin Hydrogen Bromide (HBr) in people with Spinal Cord Injury and Neurogenic Detrusor Overactivity, run by Toronto Rehabilitation Institute at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of Incontinence Episodes (time frame: 3 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2013.