Irritable Bowel Syndrome (IBS)Phase 2NCT00421707

Randomized Placebo Controlled Efficacy And Safety Study Investigating GW876008 In Patients With Irritable Bowel Syndrome

A Phase 2 study testing GW876008 in people with Irritable Bowel Syndrome (IBS), run by GlaxoSmithKline at 23 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a double-blind, placebo-controlled, randomised crossover study to investigate the efficacy and safety of GW876008 Read more about this study

Who is it for?: Ages 18 to 64 years
Conditions the study is for: Irritable Bowel Syndrome (IBS)
What is being tested?: GW876008
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 133 participants
Where: 23 sitesin 2 countries
Study dates: 14 Oct 2006to 25 Jun 2008
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 64 years
All sexes
No healthy volunteers
Adult

Who may be able to join

The subject has been diagnosed with IBS consistent with the Rome II Criteria as adapted in Appendix 3 of the protocol
The subject has normal results from a flexible sigmoidoscopy, colonoscopy, or a flexible sigmoidoscopy plus barium enema, according to subject's age, within 5 years of randomization. Otherwise, the appropriate procedure(s) must be performed and normal results obtained during the 7-day procedure window (prior to randomization):
If the subject is < 50 years of age and has not had a colonic examination within 5 years of the Screening Visit, flexible sigmoidoscopy, or colonoscopy must be performed.
If the subject is = 50 years of age and has not had a colonic examination within 5 years of the Screening Visit, a colonoscopy or flexible sigmoidoscopy plus barium enema must be performed.
Colonic procedure results must be known prior to randomization into the study and dispensing study medication
During the two-week screening phase, the subject must have conducted self assessments on = 10 days of 14 day (with 80% compliance on daily IVRS calls) compliance assessment using the telephone data entry system

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
Subject reported no stool for 7 consecutive days during the two-week screening phase responsible considers the subject unfit for the study
The subject has a concurrent illness or disability that may affect the interpretation of clinical data, or otherwise contraindicates participation in this clinical study (e.g., an unstable cardiovascular, autoimmune, renal, hepatic, pulmonary, endocrine, metabolic, gastrointestinal, haematological, or neurological condition).

Trial locations and contacts

23 sites in 2 countries.

Country

City, postcode or hospital

23 sites in 2 countries

United States17 sites

GSK Investigational Site
Anderson, South Carolina, 29621
GSK Investigational Site
Austin, Texas, 78705
GSK Investigational Site
Boston, Massachusetts, 02215
GSK Investigational Site
Chattanooga, Tennessee, 37404
GSK Investigational Site
Concord, California, 94520
GSK Investigational Site
Germantown, Tennessee, 38138
GSK Investigational Site
Greensboro, North Carolina, 27408
GSK Investigational Site
Greer, South Carolina, 29651
GSK Investigational Site
Los Angeles, California, 90095
GSK Investigational Site
Louisville, Kentucky, 40202
GSK Investigational Site
Lynchburg, Virginia, 24502
GSK Investigational Site
Monroe, Louisiana, 71201
GSK Investigational Site
San Antonio, Texas, 78209
GSK Investigational Site
Sherwood, Arkansas, 72120
GSK Investigational Site
St Louis, Missouri, 63110
GSK Investigational Site
Stockbridge, Georgia, 30281
GSK Investigational Site
Tampa, Florida, 33614

Other trials in United States

Canada6 sites

GSK Investigational Site
Saskatoon, Saskatchewan, S7K 1J5
GSK Investigational Site
Toronto, Ontario, M3H 5S4
GSK Investigational Site
Toronto, Ontario, M3J 1N2
GSK Investigational Site
Toronto, Ontario, M3N 2V7
GSK Investigational Site
Toronto, Ontario, M9W 4L6
GSK Investigational Site
Truro, Nova Scotia, B2N 1L2

Other trials in Canada

About this study

Official title: A Phase 2 PoC in IBS Patients With the CRF1 Receptor Anatgonist, GSK876008

This is a double-blind, placebo-controlled, randomised crossover study to investigate the efficacy and safety of GW876008

Conditions: Irritable Bowel Syndrome (IBS)
Being tested: GW876008, Placebo
Keywords: Irritable Bowel Syndrome safety
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.

GW876008Drug
PlaceboOther

Study groups in NCT00421707
Study group	Role	What they receive
GW876008	Experimental	GW876008 Receives: Drug: GW876008
Placebo	Placebo comparator	Placebo Receives: Drug: GW876008; Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Average Adequate Relief Rate During the Last 4 Weeks of the Treatment Periods (Weeks 3-6. in Period 1, Weeks 12-15 in Period 2).
For the assessment of average adequate relief rate from IBS symptoms for a participant was planned by collecting the response of a question 'In the past seven days have you had adequate relief of your IBS pain or discomfort? However, in error, the question was not collected in the IVRS system. Therefore, data for this endpoints was not collected during this study.
Measured: Up to Day 105 (weeks 3-6. in period 1, weeks 12-15 in period 2)
Number of Participants With Changes in Weekly Adequate Relief Rates During the Treatment Periods (Weeks 1-6 in Period 1 and Weeks 9-15 in Period 2).
For the assessment of changes in weekly adequate relief rates during the treatment periods was planned by collecting the response of a question. Overall response was defined as having achieved adequate relief in last 4 weeks. However, in error, the question was not collected in the IVRS system. Therefore, data for this endpoints was not collected during this study.
Measured: Up to Day 105 (weeks 1-6 in period 1 and weeks 9-15 in period 2).
Number of Participants With Adequate Relief of IBS Pain and Discomfort on All 4 of the Last 4 Weeks of the Treatment Phase Treatment Periods 1 and 2
For the assessment of average adequate relief rate from IBS symptoms for a participant was planned by collecting the response of a question whether weekly adequate relief from IBS symptoms was achieved?. However, in error, the question was not collected in the IVRS system. Therefore, data for this endpoints was not collected during this study.
Measured: Up to Day 105
Mean Global Improvement Scale (GIS) Responder Rate Over the Last Four Weeks by Regimen
The GIS is comprised of ten questions, all rated on a seven point scale ranging from substantially worse (7) to substantially improved (1). GIS assesses the participant's improvement (or worsening) as assessed by the clinician on a 7-point scale: 1: very much improved; 2: much improved; 3: minimally improved; 4: no change; 5: minimally worse; 6: much worse; or 7: very much worse for diarrhea, constipation, stool frequency, stool consistency, urgency, bloating, incomplete evacuation, and straining. Values reported are less than the minimum score on scale as the rate is the proportion of the last four weeks that the participant is a responder.
Measured: Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2)
Ratings on Irritable Bowel Syndrome Quality of Life (IBSQoL) Scale
The IBSQoL is a self-report quality-of-life measure specific to IBS that can be used to assess the impact of IBS and its treatment. The IBSQoL consists of 30 statements about bowel problems, which formed 9 scales: emotional health, mental health, health belief, sleep, energy, physical functioning, diet, social role, physical role and sexual relation. All 9 scales were rated on a five-point response scale ranging from 1 (always) to 5 (never). Scores for individual items were averaged to obtain a total score for each subscale of IBSQoL. Then transformed to a 0-100 scale for ease of interpretation with higher scores indicating better IBS-specific quality of life. Transformed scale score = (raw score - lowest possible scale score)/ (scale range) X 100. The data presented for individual scale.
Measured: Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2)

Secondary outcomes (8)

Number of Participants With Improvements in Pain and Discomfort
Number of participants with improvements in pain and discomfort on GIS were presented. GIS assesses the participant's improvement (or worsening) as assessed by the clinician on a 7-point scale: 1: very much improved; 2: much improved; 3: minimally improved; 4: no change; 5: minimally worse; 6: much worse; or 7: very much worse on specified time points. Responder = Yes if A responder answered either 'moderately improved' or 'substantially improved'.
Measured: Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2)
Change From Baseline in Pain Severity Scores
Pain severity scores from the 11-point scale and it's corresponding change from Baseline scores was summarized by treatment group for the last 4 weeks (i.e. weeks 3-6 and Weeks 12-15) of treatment period. Scale from 0 to 10, 0 meaning no pain, 10 worst possible pain. Lower values represent a better outcome. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting baseline value from specified time point value. Reported data values are lesser than minimum score on scale as change from Baseline is reported.
Measured: Baseline (Day 1) and up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2)
Percentages of Pain-free Days
Abdominal pain free days are those days where the participant reported a score of '0' for abdominal pain at its worst. Abdominal Pain (in the last 24 hours) is based on an 11-point scale where 0 represents no abdominal pain and 10 represents very severe abdominal pain.
Measured: Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2)
Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function
The GIS comprised of ten questions, all rated on a seven point scale ranging from substantially worse (7) to substantially improved (1). GIS assesses the participant's improvement (or worsening) as assessed by the clinician on a 7-point scale: 1: very much improved; 2: much improved; 3: minimally improved; 4: no change; 5: minimally worse; 6: much worse; or 7: very much worse. Number of participants who showed improvement and changes on the scale were presented. Participants were counted as "Yes" if they scored 1-3, and as "No" if they scored 4-7.
Measured: Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2)
Plasma Concentrations of GW876008 at Week 3 and 6
For Week 3, 6, 9, 12, and 15 visits blood samples were collected at: pre-dose (after the pre ECG measurement and just before am dose) and immediately following the 1-3 hour post-dose ECG measurement and concentration of GW876008 was analyzed. Data for Week 3 and 6 was presented.
Measured: Week 3 and 6 visits. Pre-dose [after the pre Electrocardiogram (ECG) measurement and just before am dose] and immediately following the 1-3 hour post-dose ECG measurement
IBS Composite Symptom Score
Investigation of possible composite symptom score was planned. The data was not collected for composite symptom score.
Measured: Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2)
Changes in Patient Health Questionnaire-15 Somatization Scale (PHQ-15) Score With Treatment
The PHQ-15 comprised of 15 somatic symptoms from the PHQ, each symptom scored from 0 to 2, where 0 ("Not bothered at all"), 1 (Bothered a little) 2 ("bothered a lot"). This questionnaire was completed at screening, and all study visits. Total score range was 0-30, where 0 indicated Not bothered at all and 30 indicated "bothered a lot". Higher score indicated greater severity of somatization symptoms.
Measured: Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2)
Summary of Anxiety and/or Depression on Hospital Anxiety and Depression Scale (HAD)
HAD Scale was used to assess the severity of symptoms of anxiety and depression in participants. There were 14 questions. Seven questions related to depression and seven questions related to anxiety. Participants rated the severity of symptoms in the answer to each question. There were four options in each answer, from which participants had to select one. Responses were scored on a scale of 0, 1, 2 or 3, where 0 indicated best and 3 indicated worse. Total score ranged from 0-42 where 0 indicated absence of symptoms and higher scores indicated higher anxiety/depression complains. This questionnaire was completed at screening, and all study visits.
Measured: Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Oct 200625 Jun 2008

First posted12 Jan 2007 (estimated)
Study start14 Oct 2006
Primary completion25 Jun 2008
Study completion25 Jun 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 133 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00421707
Sponsor's protocol ID: CRI105626
Status last verified: Nov 2017
First submitted: 10 Jan 2007
Last updated: 31 Jan 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Irritable Bowel Syndrome (IBS) trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2 PoC in IBS Patients With the CRF1 Receptor Anatgonist, GSK876008
ClinicalTrials.gov ID: NCT00421707
Acronym / sponsor ID: CRI105626
Conditions: Irritable Bowel Syndrome (IBS)
Keywords: Irritable Bowel Syndrome safety
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 133 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 14 Oct 2006 (actual)
Primary completion: 25 Jun 2008 (actual)
Study completion: 25 Jun 2008 (actual)
First posted: 12 Jan 2007 (estimated)
Results: Posted 26 Dec 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a double-blind, placebo-controlled, randomised crossover study to investigate the efficacy and safety of GW876008

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
GW876008	Experimental	Drug: GW876008GW876008
Placebo	Placebo comparator	Drug: GW876008, Other: PlaceboPlacebo

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (6 listed)

The subject has been diagnosed with IBS consistent with the Rome II Criteria as adapted in Appendix 3 of the protocol
The subject has normal results from a flexible sigmoidoscopy, colonoscopy, or a flexible sigmoidoscopy plus barium enema, according to subject's age, within 5 years of randomization. Otherwise, the appropriate procedure(s) must be performed and normal results obtained during the 7-day procedure window (prior to randomization):
If the subject is < 50 years of age and has not had a colonic examination within 5 years of the Screening Visit, flexible sigmoidoscopy, or colonoscopy must be performed.
If the subject is = 50 years of age and has not had a colonic examination within 5 years of the Screening Visit, a colonoscopy or flexible sigmoidoscopy plus barium enema must be performed.
Colonic procedure results must be known prior to randomization into the study and dispensing study medication

Key exclusion criteria (3 listed)

As a result of any of the medical interview, physical examination, evaluation of mental state and psychiatric history or screening investigations the physician
Subject reported no stool for 7 consecutive days during the two-week screening phase responsible considers the subject unfit for the study
The subject has a concurrent illness or disability that may affect the interpretation of clinical data, or otherwise contraindicates participation in this clinical study (e.g., an unstable cardiovascular, autoimmune, renal, hepatic, pulmonary, endocrine, metabolic, gastrointestinal, haematological, or neurological condition).

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	Drug	GW876008, Placebo
Placebo	Other	Placebo

Primary outcome

Number of Participants With Average Adequate Relief Rate During the Last 4 Weeks of the Treatment Periods (Weeks 3-6. in Period 1, Weeks 12-15 in Period 2).
Time frame: Up to Day 105 (weeks 3-6. in period 1, weeks 12-15 in period 2)
For the assessment of average adequate relief rate from IBS symptoms for a participant was planned by collecting the response of a question 'In the past seven days have you had adequate relief of your IBS pain or discomfort? However, in error, the question was not collected in the IVRS system. Therefore, data for this endpoints was not collected during this study.
Number of Participants With Changes in Weekly Adequate Relief Rates During the Treatment Periods (Weeks 1-6 in Period 1 and Weeks 9-15 in Period 2).
Time frame: Up to Day 105 (weeks 1-6 in period 1 and weeks 9-15 in period 2).
For the assessment of changes in weekly adequate relief rates during the treatment periods was planned by collecting the response of a question. Overall response was defined as having achieved adequate relief in last 4 weeks. However, in error, the question was not collected in the IVRS system. Therefore, data for this endpoints was not collected during this study.
Number of Participants With Adequate Relief of IBS Pain and Discomfort on All 4 of the Last 4 Weeks of the Treatment Phase Treatment Periods 1 and 2
Time frame: Up to Day 105
For the assessment of average adequate relief rate from IBS symptoms for a participant was planned by collecting the response of a question whether weekly adequate relief from IBS symptoms was achieved?. However, in error, the question was not collected in the IVRS system. Therefore, data for this endpoints was not collected during this study.
Mean Global Improvement Scale (GIS) Responder Rate Over the Last Four Weeks by Regimen
Time frame: Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2)
The GIS is comprised of ten questions, all rated on a seven point scale ranging from substantially worse (7) to substantially improved (1). GIS assesses the participant's improvement (or worsening) as assessed by the clinician on a 7-point scale: 1: very much improved; 2: much improved; 3: minimally improved; 4: no change; 5: minimally worse; 6: much worse; or 7: very much worse for diarrhea, constipation, stool frequency, stool consistency, urgency, bloating, incomplete evacuation, and straining. Values reported are less than the minimum score on scale as the rate is the proportion of the last four weeks that the participant is a responder.
Ratings on Irritable Bowel Syndrome Quality of Life (IBSQoL) Scale
Time frame: Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2)
The IBSQoL is a self-report quality-of-life measure specific to IBS that can be used to assess the impact of IBS and its treatment. The IBSQoL consists of 30 statements about bowel problems, which formed 9 scales: emotional health, mental health, health belief, sleep, energy, physical functioning, diet, social role, physical role and sexual relation. All 9 scales were rated on a five-point response scale ranging from 1 (always) to 5 (never). Scores for individual items were averaged to obtain a total score for each subscale of IBSQoL. Then transformed to a 0-100 scale for ease of interpretation with higher scores indicating better IBS-specific quality of life. Transformed scale score = (raw score - lowest possible scale score)/ (scale range) X 100. The data presented for individual scale.

8 secondary outcomes

Number of Participants With Improvements in Pain and Discomfort
Time frame: Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2)
Change From Baseline in Pain Severity Scores
Time frame: Baseline (Day 1) and up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2)
Percentages of Pain-free Days
Time frame: Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2)
Number of Participants With Improvements in Bowel Function and Changes in Individual Bowel Symptoms/Function
Time frame: Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2)
Plasma Concentrations of GW876008 at Week 3 and 6
Time frame: Week 3 and 6 visits. Pre-dose [after the pre Electrocardiogram (ECG) measurement and just before am dose] and immediately following the 1-3 hour post-dose ECG measurement
IBS Composite Symptom Score
Time frame: Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2)
Changes in Patient Health Questionnaire-15 Somatization Scale (PHQ-15) Score With Treatment
Time frame: Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2)
Summary of Anxiety and/or Depression on Hospital Anxiety and Depression Scale (HAD)
Time frame: Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2)

Results and safety

Results posted to the registry on 26 Dec 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence A/X/B	67	56
Sequence B/X/A	65	56

Primary outcome: Number of Participants With Average Adequate Relief Rate During the Last 4 Weeks of the Treatment Periods (Weeks 3-6. in Period 1, Weeks 12-15 in Period 2).

Time frame: Up to Day 105 (weeks 3-6. in period 1, weeks 12-15 in period 2)

Population analysed: Intent to Treat population comprised of all participants who were randomized to treatment, who received at least one dose of double blind medication and for whom at least one valid post baseline efficacy assessment was available.

Primary outcome: Number of Participants With Changes in Weekly Adequate Relief Rates During the Treatment Periods (Weeks 1-6 in Period 1 and Weeks 9-15 in Period 2).

Time frame: Up to Day 105 (weeks 1-6 in period 1 and weeks 9-15 in period 2).

Population analysed: Intent to Treat population.

Primary outcome: Number of Participants With Adequate Relief of IBS Pain and Discomfort on All 4 of the Last 4 Weeks of the Treatment Phase Treatment Periods 1 and 2

Time frame: Up to Day 105

Population analysed: Intent to Treat population

Primary outcome: Mean Global Improvement Scale (GIS) Responder Rate Over the Last Four Weeks by Regimen

Time frame: Up to Day 105 (weeks 3-6 in period 1, weeks 12-15 in period 2). Mean (Standard Deviation). Unit: Proportion of participants responded

Measure	GW876008 125 mg n = 117	Placebo n = 117
Pain and Discomfort	0.26 (0.357)	0.22 (0.334)
diarrhea	0.30 (0.377)	0.28 (0.383)
Constipation	0.18 (0.319)	0.16 (0.295)
Stool Frequency	0.25 (0.362)	0.24 (0.349)
Stool Consistency	0.24 (0.370)	0.21 (0.345)
Urgency	0.24 (0.365)	0.25 (0.363)
Bloating	0.18 (0.329)	0.16 (0.287)
Incomplete Evacuation	0.19 (0.350)	0.16 (0.307)

Population analysed: Intent to Treat population. Only those participants available at the specified time points were analyzed.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to Day 147. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GW876008 125 mg	0 of 119 (0%)	9 of 119 (7.6%)	0 of 119
Placebo	1 of 120 (0.8%)	5 of 120 (4.2%)	0 of 120
Placebo Washout	0 of 112 (0%)	2 of 112 (1.8%)	0 of 112

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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

23 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GW876008 in people with Irritable Bowel Syndrome (IBS), run by GlaxoSmithKline at 23 sites in 2 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 6 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 31 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in United States, Canada. 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 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?

Yes. Results are posted in the registry (first posted 26 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Average Adequate Relief Rate During the Last 4 Weeks of the Treatment Periods (Weeks 3-6. in Period 1, Weeks 12-15 in Period 2). (time frame: Up to Day 105 (weeks 3-6. in period 1, weeks 12-15 in period 2)). The study lists 5 primary outcomes in all. 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 NCT00421707.

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 31 Jan 2018.