Overactive BladderPhase 1NCT00501267
A Study To Test The Interaction of Two Medications for Treatment of Overactive Bladder
A Phase 1 study testing solabegron and oxybutynin in people with Overactive Bladder, run by GlaxoSmithKline at 1 site in United States.
Trial summary
The purpose of this study is to determine the effect of repeat doses of solabegron and oxybutynin when taken alone or together Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- solabegron and oxybutynin
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Aug 2007
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adult males \& females ages 18-65;
- Body weight >50kg; BMI between 19-32;
- Signed and dated informed consent; QTc Interval <450 msec;
Who cannot join
- Resting blood pressure >140/90 mmHg or HR >100 at screening;
- History of drug allergy or other allergy which, in the opinion of the PI, contraindicates their participation;
- Positive urine drug, alcohol or serum pregnancy test at screening and prior to dosing;
- Positive HIV, Hepatitis B, C at screening; use of medications (except acetaminophen)or vitamins or herbal supplements within 7 days or 5 half lives prior to dosing and during study;
- history of urinary retention, gastric retention, and other sever gastrointestinal motility conditions, uncontrolled narrow-angle glaucoma or who are at risk for these conditions;
- history of chronic constipation and/or regular laxative use; donation of more than 500mL of blood within 56 days prior to dosing;
- clinically relevant abnormality identified during screening process or any medical condition or circumstance making the subject unsuitable for participation based on the Investigators assessment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Repeat Dose Study to Investigate the Pharmacokinetics, Safety and Tolerability of Solabegron (GW427353) in Combination With Oxybutynin in Healthy Adult Subjects.
The purpose of this study is to determine the effect of repeat doses of solabegron and oxybutynin when taken alone or together
- Conditions
- Overactive Bladder
- Being tested
- solabegron and oxybutynin
- Keywords
- solabegron,, oxybutynin,, healthy adults,, drug interaction
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
solabegron and oxybutyninDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Absorption rate of solabegron and oxybutynin
Measured: as measured by multiple blood draws after repeat dosing
Secondary outcomes (1)
To assess bladder function
Measured: prior to dosing Session 1 and post dose for each session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2007 (estimated)
- Study startJun 2007
- Primary completionAug 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- GSK Clinical Trials, MD, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00501267
- Sponsor's protocol ID
- B3C109868
- Status last verified
- Apr 2015
- First submitted
- 13 Jul 2007
- Last updated
- 15 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Repeat Dose Study to Investigate the Pharmacokinetics, Safety and Tolerability of Solabegron (GW427353) in Combination With Oxybutynin in Healthy Adult Subjects.
- ClinicalTrials.gov ID
- NCT00501267
- Acronym / sponsor ID
- B3C109868
- Conditions
- Overactive Bladder
- Keywords
- solabegron,, oxybutynin,, healthy adults,, drug interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 16 Jul 2007 (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 determine the effect of repeat doses of solabegron and oxybutynin when taken alone or together
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy adult males \& females ages 18-65;
- Body weight >50kg; BMI between 19-32;
- Signed and dated informed consent; QTc Interval <450 msec;
Key exclusion criteria (7 listed)
- Resting blood pressure >140/90 mmHg or HR >100 at screening;
- History of drug allergy or other allergy which, in the opinion of the PI, contraindicates their participation;
- Positive urine drug, alcohol or serum pregnancy test at screening and prior to dosing;
- Positive HIV, Hepatitis B, C at screening; use of medications (except acetaminophen)or vitamins or herbal supplements within 7 days or 5 half lives prior to dosing and during study;
- history of urinary retention, gastric retention, and other sever gastrointestinal motility conditions, uncontrolled narrow-angle glaucoma or who are at risk for these conditions;
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 |
|---|---|---|
| solabegron and oxybutynin | Drug | – |
Primary outcome
Absorption rate of solabegron and oxybutynin
Time frame: as measured by multiple blood draws after repeat dosing
1 secondary outcome
To assess bladder function
Time frame: prior to dosing Session 1 and post dose for each session
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 15 Apr 2015.
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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.
GSK Clinical Trials, MD study director
GlaxoSmithKline
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 solabegron and oxybutynin in people with Overactive Bladder, run by GlaxoSmithKline 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 7 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 15 Apr 2015. 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. 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?
Absorption rate of solabegron and oxybutynin (time frame: as measured by multiple blood draws after repeat dosing). 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 15 Apr 2015.