HealthyPhase 1NCT00926926
Effects of Oxybutynin Topical Gel on Gastric Emptying
A Phase 1 study testing Oxybutynin Chloride Gel in people with Healthy, run by Watson Pharmaceuticals at 1 site in United States.
Trial summary
This study explores the effect of oxybutynin topical gel on gastric emptying Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Oxybutynin Chloride Gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Jul 2009
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult, healthy, post-menopausal females
Who cannot join
- Patients for whom OTG or acetaminophen is contraindicated.
- Abnormality of the GI tract.
- Taking drugs that affect gastric motility.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Oxybutynin Chloride Topical Gel on Gastric Emptying, Using the Acetaminophen Absorption Test
This study explores the effect of oxybutynin topical gel on gastric emptying
- Conditions
- Healthy
- Being tested
- Oxybutynin Chloride Gel, Placebo Gel
- Keywords
- Healthy volunteer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxybutynin Chloride GelDrug
Once daily for 7 days, followed by single dose of acetaminophen
Placebo GelDrug
Once daily for 7 days, followed by single dose of acetaminophen
| Study group | Role | What they receive |
|---|---|---|
| Active OTG | Experimental | Not described Receives: Drug: Oxybutynin Chloride Gel |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of oxybutynin chloride topical gel administration on gastric emptying will be assessed by comparing the single dose relative bioavailability of acetaminophen
Measured: After 7 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Watson Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Scott Olsen, MPH, Study director, Watson Laboratories
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00926926
- Sponsor's protocol ID
- OTG0901
- Status last verified
- Oct 2012
- First submitted
- 22 Jun 2009
- Last updated
- 8 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oxybutynin Chloride Topical Gel on Gastric Emptying, Using the Acetaminophen Absorption Test
- ClinicalTrials.gov ID
- NCT00926926
- Acronym / sponsor ID
- OTG0901
- Conditions
- Healthy
- Keywords
- Healthy volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Watson PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 24 Jun 2009 (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 study explores the effect of oxybutynin topical gel on gastric emptying
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active OTG | Experimental | Drug: Oxybutynin Chloride Gel |
| Placebo | Placebo comparator | Drug: Placebo Gel |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult, healthy, post-menopausal females
Key exclusion criteria (3 listed)
- Patients for whom OTG or acetaminophen is contraindicated.
- Abnormality of the GI tract.
- Taking drugs that affect gastric motility.
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 GelOnce daily for 7 days, followed by single dose of acetaminophen | Drug | Active OTG |
| Placebo GelOnce daily for 7 days, followed by single dose of acetaminophen | Drug | Placebo |
Primary outcome
The effect of oxybutynin chloride topical gel administration on gastric emptying will be assessed by comparing the single dose relative bioavailability of acetaminophen
Time frame: After 7 days of treatment
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 Oct 2012.
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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.
Scott Olsen, MPH study director
Watson Laboratories
1 site 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 Gel in people with Healthy, run by Watson Pharmaceuticals 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 1 inclusion and 3 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 Oct 2012. 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 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?
The effect of oxybutynin chloride topical gel administration on gastric emptying will be assessed by comparing the single dose relative bioavailability of acetaminophen (time frame: After 7 days of treatment). 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 Oct 2012.