Irritable Bowel SyndromePhase 2NCT00511563
A Study In Patients With Irritable Bowel Syndrome To Measure Hormone Response After Dosing With GW876008 And Gsk561679
A Phase 2 study testing GW876008 and GSK561679 in people with Irritable Bowel Syndrome, run by GlaxoSmithKline.
Trial summary
To better understand the way that GW876008 and GSK561679 work on hormone responses in patients with Irritable Bowel Syndrome. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- GW876008 and GSK561679
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2007to Nov 2012
- 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
- Has IBS as defined by the Rome II criteria.
- Clinical laboratory tests at screening showing no clinically significant abnormalities in the opinion of the Principal Investigator.
- Non-tobacco user (abstinence from tobacco use for at least 1 month before the start of the study).
Who cannot join
- As a result of any of the medical interview, physical examination, evaluation of mental state and psychiatric history or screening investigations the physician responsible considers the subject unfit for the study.
- Subject has any of the following exclusionary psychiatric conditions (Note: current diagnoses are to be based on the M.I.N.I administered at screening).
- 1. A current DSM-IV Axis I disorder such as Dysthymia, Phobia, Major Depression, Obsessive Compulsive Disorder, Body Dysmorphic disorder, or Panic Disorder as a primary diagnosis currently or within 6 months prior to the screening visit.
- 2. A current DSM-IV-TR diagnosis of Antisocial or Borderline Personality Disorder, Dementia, or another current DSM-IV-TR Axis II diagnosis that would suggest non-responsiveness to pharmacotherapy or non-compliance with the protocol; or
- 3. A current (within six months prior to Screening Visit) diagnosis of anorexia nervosa or bulimia; or
- 4. A history of Schizophrenia, Schizoaffective Disorder, or a Bipolar Disorder; or
Show all 12Show fewer
- 5. Is currently being treated by medication for any of the above psychiatric disorders. Psychiatric medications would include, but not limited to, antidepressants (e.g. SSRIs, SNRIs, TCAs) anxiolytics, antipsychotics
- Subjects who, in the investigator's judgement, pose a current, serious or suicidal or homicidal risk or have made a suicide attempt within the past 6 months or have ever been homicidal.
- subjects who have taken any medication for the treatment of IBS within 1 month prior to screening except for anti-diarrhoeal medications or laxatives for control of bowel habit which is allowed if at a stable dose for 2 weeks prior to randomisation.
- Subjects who are taking NSAIDs including aspirin on a regular basis or within 48 hours of a study day.
- Subjects with a history of PUD <10 years ago.
- The subject has a history of, or active eating disorder.
About this study
Official title: A Double-blind, Randomised, Placebo-controlled, Three-period Crossover Study to Investigate the Pharmacodynamic Effect of Two CRF-1 Antagonists GSK561679 and GW876008 on Meal Induced Cortisol Responses in Patients With IBS.
To better understand the way that GW876008 and GSK561679 work on hormone responses in patients with Irritable Bowel Syndrome.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- GW876008 and GSK561679
- Keywords
- Cortisol,, stress,, response,, Irritable Bowel Syndrome,, cytokine.
- 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.
GW876008 and GSK561679Drug
GW876008 and GSK561679
| Study group | Role | What they receive |
|---|---|---|
| GW876008 and GSK561679 | Experimental | GW876008 and GSK561679 Receives: Drug: GW876008 and GSK561679 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum cortisol / ACTH and DHEA levels
Measured: taken at 20 minute intervals over the study period.
Secondary outcomes (1)
Serum cytokine levels
Measured: taken at 20 minute intervals over the study period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2007 (estimated)
- Study startAug 2007
- Primary completionNov 2012
Why it stopped: Cancelled before active due to the results of emerging scientific data
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00511563
- Sponsor's protocol ID
- CRI109244
- Status last verified
- Feb 2015
- First submitted
- 2 Aug 2007
- Last updated
- 2 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomised, Placebo-controlled, Three-period Crossover Study to Investigate the Pharmacodynamic Effect of Two CRF-1 Antagonists GSK561679 and GW876008 on Meal Induced Cortisol Responses in Patients With IBS.
- ClinicalTrials.gov ID
- NCT00511563
- Acronym / sponsor ID
- CRI109244
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Cortisol,, stress,, response,, Irritable Bowel Syndrome,, cytokine.
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Cancelled before active due to the results of emerging scientific data
- Enrolment
- 0 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Nov 2012 (actual)
- First posted
- 6 Aug 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.
To better understand the way that GW876008 and GSK561679 work on hormone responses in patients with Irritable Bowel Syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GW876008 and GSK561679 | Experimental | Drug: GW876008 and GSK561679GW876008 and GSK561679 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Has IBS as defined by the Rome II criteria.
- Clinical laboratory tests at screening showing no clinically significant abnormalities in the opinion of the Principal Investigator.
- Non-tobacco user (abstinence from tobacco use for at least 1 month before the start of the study).
Key exclusion criteria (12 listed)
- As a result of any of the medical interview, physical examination, evaluation of mental state and psychiatric history or screening investigations the physician responsible considers the subject unfit for the study.
- Subject has any of the following exclusionary psychiatric conditions (Note: current diagnoses are to be based on the M.I.N.I administered at screening).
- 1. A current DSM-IV Axis I disorder such as Dysthymia, Phobia, Major Depression, Obsessive Compulsive Disorder, Body Dysmorphic disorder, or Panic Disorder as a primary diagnosis currently or within 6 months prior to the screening visit.
- 2. A current DSM-IV-TR diagnosis of Antisocial or Borderline Personality Disorder, Dementia, or another current DSM-IV-TR Axis II diagnosis that would suggest non-responsiveness to pharmacotherapy or non-compliance with the protocol; or
- 3. A current (within six months prior to Screening Visit) diagnosis of anorexia nervosa or bulimia; or
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 |
|---|---|---|
| GW876008 and GSK561679GW876008 and GSK561679 | Drug | GW876008 and GSK561679 |
Primary outcome
Serum cortisol / ACTH and DHEA levels
Time frame: taken at 20 minute intervals over the study period.
1 secondary outcome
Serum cytokine levels
Time frame: taken at 20 minute intervals over the study period.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 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 study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GW876008 and GSK561679 in people with Irritable Bowel Syndrome, run by GlaxoSmithKline.
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 12 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: withdrawn, as of the sponsor's last update on 2 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Serum cortisol / ACTH and DHEA levels (time frame: taken at 20 minute intervals over the study period.). 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 2 Mar 2015.