Irritable Bowel Syndrome (IBS)Phase 2NCT00394186
A Study To Investigate GW427353 In Subjects With Irritable Bowel Syndrome (IBS)
A Phase 2 study testing GW427353 in people with Irritable Bowel Syndrome (IBS), run by GlaxoSmithKline at 19 sites in 3 countries.
Trial summary
This study will test the hypothesis that GW427353, a beta-3 adrenergic agonist, will relieve IBS pain or discomfort and associated symptoms in IBS patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Irritable Bowel Syndrome (IBS)
- What is being tested?
- GW427353
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 19 sitesin 3 countries
- Study dates
- Aug 2006to not given
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of IBS which meets the Rome II criteria, screening pain score to be > 1.5 (0= no pain, 4 = very severe pain)
Who cannot join
- Subjects not meeting the Rome II criteria for the diagnosis of IBS
- Subjects with no stool for 7 days during the screen
Trial locations and contacts
19 sites in 3 countries.
19 sites in 3 countries
Australia7 sites
GSK Investigational Site
Adelaide, South Australia, 5000
GSK Investigational Site
Box Hill, Victoria, 3128
GSK Investigational Site
Caboolture, Queensland, 4510
GSK Investigational Site
Concord, New South Wales, 2139
GSK Investigational Site
Kippa-Ring, Queensland, 4021
GSK Investigational Site
Malvern, Victoria, 3144
GSK Investigational Site
Spring Hill, Queensland, 4000
Germany7 sites
GSK Investigational Site
Berlin, State of Berlin, 10629
GSK Investigational Site
Berlin, State of Berlin, 10787
GSK Investigational Site
Berlin, State of Berlin, 13125
GSK Investigational Site
Hamburg, Free and Hanseatic City of Hamburg, 20249
GSK Investigational Site
Hamburg, Free and Hanseatic City of Hamburg, 22143
GSK Investigational Site
Leipzg, Saxony, 04109
GSK Investigational Site
Witten, North Rhine-Westphalia, 58455
France5 sites
GSK Investigational Site
Issoire, 63500
GSK Investigational Site
Les Sables-d'Olonne, 85100
GSK Investigational Site
Lille, 59000
GSK Investigational Site
Saint-Quentin, 02100
GSK Investigational Site
Vitry-sur-Seine, 94400
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Crossover, Phase IIa Study to Evaluate Efficacy and Safety of the Beta-3-Adrenergic Receptor Agonist Solabegron in Subjects With Irritable Bowel Syndrome
This study will test the hypothesis that GW427353, a beta-3 adrenergic agonist, will relieve IBS pain or discomfort and associated symptoms in IBS patients.
- Conditions
- Irritable Bowel Syndrome (IBS)
- Being tested
- GW427353, Placebo
- Keywords
- GW427353, b3-Adrenergic Receptor Agonist, Irritable Bowel Syndrome (IBS), efficacy, tolerability, pharmacokinetics
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GW427353Drug
PlaceboDrug
Also called GW427353
What is being measured
The primary outcome is the main question the study is designed to answer.
completion of questionnaires by the subject, determining the average adequate relief rate
Measured: during the last 4 weeks of the treatment periods (weeks 3 to 6 in period 1 and weeks 15-18 in period 2)
Secondary outcomes (4)
Blood levels of GW427353
Measured: Week 1, 13
Questionnaire
Measured: Weeks 1, 6, 12, 18, 24
ECG, vital signs, adverse events
Measured: each visit
clinical lab tests
Measured: Weeks 1, 6, 12, 18, 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2006 (estimated)
- Study startAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel Syndrome (IBS)Studies 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 2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 100 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
- NCT00394186
- Sponsor's protocol ID
- B3I105940
- Status last verified
- May 2009
- First submitted
- 27 Oct 2006
- Last updated
- 18 May 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Crossover, Phase IIa Study to Evaluate Efficacy and Safety of the Beta-3-Adrenergic Receptor Agonist Solabegron in Subjects With Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT00394186
- Acronym / sponsor ID
- B3I105940
- Conditions
- Irritable Bowel Syndrome (IBS)
- Keywords
- GW427353, b3-Adrenergic Receptor Agonist, Irritable Bowel Syndrome (IBS), efficacy, tolerability, pharmacokinetics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- First posted
- 31 Oct 2006 (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 will test the hypothesis that GW427353, a beta-3 adrenergic agonist, will relieve IBS pain or discomfort and associated symptoms in IBS patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of IBS which meets the Rome II criteria, screening pain score to be > 1.5 (0= no pain, 4 = very severe pain)
Key exclusion criteria (2 listed)
- Subjects not meeting the Rome II criteria for the diagnosis of IBS
- Subjects with no stool for 7 days during the screen
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 |
|---|---|---|
| GW427353 | Drug | – |
| PlaceboAlso: GW427353 | Drug | – |
Primary outcome
completion of questionnaires by the subject, determining the average adequate relief rate
Time frame: during the last 4 weeks of the treatment periods (weeks 3 to 6 in period 1 and weeks 15-18 in period 2)
4 secondary outcomes
Blood levels of GW427353
Time frame: Week 1, 13
Questionnaire
Time frame: Weeks 1, 6, 12, 18, 24
ECG, vital signs, adverse events
Time frame: each visit
clinical lab tests
Time frame: Weeks 1, 6, 12, 18, 24
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 18 May 2009.
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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
19 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GW427353 in people with Irritable Bowel Syndrome (IBS), run by GlaxoSmithKline at 19 sites in 3 countries.
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 2 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 18 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Australia, Germany, France. 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 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?
completion of questionnaires by the subject, determining the average adequate relief rate (time frame: during the last 4 weeks of the treatment periods (weeks 3 to 6 in period 1 and weeks 15-18 in period 2)). 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 18 May 2009.