Healthy VolunteersPhase 1NCT00752141
Cognitive Effects of Oral Oxybutynin and Oxybutynin Chloride Topical Gel in Older Volunteers
A Phase 1 study testing oxybutynin chloride immediate-release and oxybutynin chloride topical gel in people with Healthy Volunteers, run by Watson Pharmaceuticals at 6 sites in United States.
Trial summary
The purpose of this study is to explore the possible cognitive effects of oxybutynin tablets and oxybutynin gel. Read more about this study
- Who is it for?
- Ages 60 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- oxybutynin chloride immediate-release and oxybutynin chloride topical gel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 153 participants
- Where
- 6 sitesUnited States
- Study dates
- Sep 2008to Oct 2008
- Phase
- Phase 1
- 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 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females aged 60 and over
- 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 oxybutynin is contraindicated
- History of narrow-angle glaucoma or urinary or gastric retention
- Current use of drugs known to effect memory and cognition
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Study site
Atlanta, Georgia, 30341-4155
Study site
Maitland, Florida, 32751
Study site
Naples, Florida, 34102
Study site
National City, California, 91950
Study site
Ocala, Florida, 34471
Study site
Tucson, Arizona, 85741-3656
About this study
The purpose of this study is to explore the possible cognitive effects of oxybutynin tablets and oxybutynin gel.
- Conditions
- Healthy Volunteers
- Being tested
- oxybutynin chloride immediate-release, oxybutynin chloride topical gel, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxybutynin chloride immediate-releaseDrug
capsule containing oxybutynin chloride immediate-release 5 mg tablet administered three times daily, and placebo gel administered once daily
oxybutynin chloride topical gelDrug
oxybutynin chloride topical gel applied once daily, and capsule containing placebo tablet administered three times daily
placeboOther
capsule containing placebo tablet administered three times daily, and placebo gel administered once daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | oral oxybutynin Receives: Drug: oxybutynin chloride immediate-release |
| 2 | Experimental | oxybutynin topical gel Receives: Drug: oxybutynin chloride topical gel |
| 3 | Placebo comparator | placebo tablets plus placebo gel Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of accuracy of delayed recall name-phase association test
Measured: one week
Secondary outcomes (1)
Effects on other cognitive domains measured by various tests
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Watson Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00752141
- Sponsor's protocol ID
- OTG0801
- Status last verified
- Sep 2011
- First submitted
- 11 Sep 2008
- Last updated
- 23 Sep 2011
- Results posted
- No
Publications
Kay GG, Staskin DR, MacDiarmid S, McIlwain M, Dahl NV. Cognitive effects of oxybutynin chloride topical gel in older healthy subjects: a 1-week, randomized, double-blind, placebo- and active-controlled study. Clin Drug Investig. 2012 Oct 1;32(10):707-14. doi: 10.1007/BF03261924.
PubMed 22909146
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Effects of Oral Oxybutynin and Oxybutynin Chloride Topical Gel in Older Volunteers
- ClinicalTrials.gov ID
- NCT00752141
- Acronym / sponsor ID
- OTG0801
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Watson PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Oct 2008 (actual)
- First posted
- 15 Sep 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.
The purpose of this study is to explore the possible cognitive effects of oxybutynin tablets and oxybutynin gel.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: oxybutynin chloride immediate-releaseoral oxybutynin |
| 2 | Experimental | Drug: oxybutynin chloride topical geloxybutynin topical gel |
| 3 | Placebo comparator | Other: placeboplacebo tablets plus placebo gel |
Who may qualify
- Ages
- 60 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males and females aged 60 and over
- 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 oxybutynin is contraindicated
- History of narrow-angle glaucoma or urinary or gastric retention
- 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 |
|---|---|---|
| oxybutynin chloride immediate-releasecapsule containing oxybutynin chloride immediate-release 5 mg tablet administered three times daily, and placebo gel administered once daily | Drug | 1 |
| oxybutynin chloride topical geloxybutynin chloride topical gel applied once daily, and capsule containing placebo tablet administered three times daily | Drug | 2 |
| placebocapsule containing placebo tablet administered three times daily, and placebo gel administered once daily | Other | 3 |
Primary outcome
Measure of accuracy of delayed recall name-phase association test
Time frame: one week
1 secondary outcome
Effects on other cognitive domains measured by various tests
Time frame: one week
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 Sep 2011.
- Derived from this study: PubMed 22909146Kay GG, Staskin DR, MacDiarmid S, McIlwain M, Dahl NV. Cognitive effects of oxybutynin chloride topical gel in older healthy subjects: a 1-week, randomized, double-blind, placebo- and active-controlled study. Clin Drug Investig. 2012 Oct 1;32(10):707-14. doi: 10.1007/BF03261924.
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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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing oxybutynin chloride immediate-release and oxybutynin chloride topical gel in people with Healthy Volunteers, run by Watson Pharmaceuticals at 6 sites 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 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Measure of accuracy of delayed recall name-phase association test (time frame: one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00752141, which also lists 1 linked publication.
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 Sep 2011.