Healthy VolunteersPhase 2NCT00170768
Cognitive Effects of Darifenacin and Oxybutynin Extended Release in Volunteers Aged 60 and Over
A Phase 2 study testing Darifenacin and Oxybutynin in people with Healthy Volunteers, run by Novartis at 1 site in United States.
Trial summary
The purpose of this study is to explore the possible cognitive effects of darifenacin modified release and long-acting oxybutynin. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Darifenacin and Oxybutynin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2005to May 2005
- Phase
- Phase 2
- 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 60 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Males and females aged 60 and over
- United States English as a primary language
- Given written informed consent by signing and dating an informed consent form prior to study entry
Who cannot join
- Current diseases in which the use of anti-cholinergic drugs is contraindicated, including the use of drugs with anti-cholinergic effects
- Volunteers with history of urinary retention or current bladder outlet obstruction, as determined by the investigator
- Other protocol defined inclusion/exclusion criteria may apply.
- Current use of drugs known to effect memory and cognition Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington Neuropsychological Institute LLC Georgetown
Washington D.C., District of Columbia, 20016
About this study
The purpose of this study is to explore the possible cognitive effects of darifenacin modified release and long-acting oxybutynin.
- Conditions
- Healthy Volunteers
- Being tested
- Darifenacin, Oxybutynin, Placebo
- Keywords
- Darifenacin, oxybutynin, cognition, memory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DarifenacinDrug
Also called Enablex
Darifenacin modified release 7,5 mg tablets once daily titrated to 15 mg once daily
OxybutyninDrug
Oxybutynin extended release 10 mg tablet once daily titrated to 15 mg, then to 20 mg once daily
PlaceboDrug
Placebo once daily tablet (sham titration)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Darifenacin Receives: Drug: Darifenacin |
| 2 | Active comparator | Oxybutynin Receives: Drug: Oxybutynin |
| 3 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive effect: measure of accuracy of delayed recall name-phase association test at week 3.
Secondary outcomes (2)
Cognitive effect: measure of accuracy of delayed recall name-phase association test at week 1 & 2.
Effects on other cognitive domains measured by various tests at week 1,2 and 3.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startFeb 2005
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis, Study chair, East Hanover NJ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00170768
- Sponsor's protocol ID
- CDAR328A2403
- Status last verified
- Jan 2008
- First submitted
- 9 Sep 2005
- Last updated
- 23 Jan 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Effects of Darifenacin and Oxybutynin Extended Release in Volunteers Aged 60 and Over
- ClinicalTrials.gov ID
- NCT00170768
- Acronym / sponsor ID
- CDAR328A2403
- Conditions
- Healthy Volunteers
- Keywords
- Darifenacin, oxybutynin, cognition, memory
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Feb 2005
- Study completion
- May 2005 (actual)
- First posted
- 15 Sep 2005 (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.
The purpose of this study is to explore the possible cognitive effects of darifenacin modified release and long-acting oxybutynin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: DarifenacinDarifenacin |
| 2 | Active comparator | Drug: OxybutyninOxybutynin |
| 3 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males and females aged 60 and over
- United States English as a primary language
- Given written informed consent by signing and dating an informed consent form prior to study entry
Key exclusion criteria (4 listed)
- Current diseases in which the use of anti-cholinergic drugs is contraindicated, including the use of drugs with anti-cholinergic effects
- Volunteers with history of urinary retention or current bladder outlet obstruction, as determined by the investigator
- Other protocol defined inclusion/exclusion criteria may apply.
- Current use of drugs known to effect memory and cognition Other protocol-defined inclusion/exclusion criteria may apply
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 |
|---|---|---|
| DarifenacinAlso: EnablexDarifenacin modified release 7,5 mg tablets once daily titrated to 15 mg once daily | Drug | 1 |
| OxybutyninOxybutynin extended release 10 mg tablet once daily titrated to 15 mg, then to 20 mg once daily | Drug | 2 |
| PlaceboPlacebo once daily tablet (sham titration) | Drug | 3 |
Primary outcome
Cognitive effect: measure of accuracy of delayed recall name-phase association test at week 3.
2 secondary outcomes
Cognitive effect: measure of accuracy of delayed recall name-phase association test at week 1 & 2.
Effects on other cognitive domains measured by various tests at week 1,2 and 3.
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 23 Jan 2008.
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Screening Protocol
Pain
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.
Novartis study chair
East Hanover NJ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Darifenacin and Oxybutynin in people with Healthy Volunteers, run by Novartis at 1 site in United States.
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 3 inclusion and 4 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 23 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Cognitive effect: measure of accuracy of delayed recall name-phase association test at week 3.. 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 23 Jan 2008.