A Phase 2 interventional study of Placebo and Camlipixant in Irritable Bowel Syndrome, sponsored by GlaxoSmithKline. Recruiting at 114 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Treatment
Among 16 studies in Irritable Bowel Syndrome by GlaxoSmithKline — 1 open to participants now, 1 under way, none of them phase 3. Irritable Bowel Syndrome · GlaxoSmithKline.
Among the 16 studies in Irritable Bowel Syndrome by GlaxoSmithKline, this one is the 4th largest by planned enrollment, is the only one that started in 2026, is one of 8 in phase 2, and was the 16th registered.
1,116 studies on the registry are indexed under Irritable Bowel Syndrome; 208 are open to participants now.
Browse Irritable Bowel Syndrome studies →1 of the 16 studies in Irritable Bowel Syndrome by GlaxoSmithKline is open now, in 1 country.
By country, each count listing its studies:
Of the 126 Irritable Bowel Syndrome studies recruiting now, 33 (26%) set no upper age limit and 83 (66%) stop at 75 or younger; 18 take children under 18; 28 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
16 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 1 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 420 is above the median of 70 across 896 interventional studies indexed under Irritable Bowel Syndrome.
Median enrollment 48 across the 16 interventional studies. Of the 14 that completed or were terminated, 4 (29%) have results posted.
This tab as a report to print or save as PDF → With an account.
GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 117 are open to participants now.
Of its 265 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
1 of the studies in Irritable Bowel Syndrome by GlaxoSmithKline that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07519395GlaxoSmithKlineA Study to Investigate Abdominal Symptoms With Camlipixant Compared With Placebo in Adults With Irritable Bowel Syndrome - Diarrhea (IBS-D) and Irritable Bowel Syndrome - Mixed (IBS-M) | 2027-03-09 |
Add it to your calendar (.ics) → With an account.
Among the 16 studies in Irritable Bowel Syndrome by GlaxoSmithKline, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
This study is designed to evaluate the efficacy and safety of camlipixant in adults with IBS-D and IBS-M. The study has two parts. After the first part, some participants will be randomly chosen again to either get a higher dose or stop the drug.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Prior use of more than two of the following therapies or classes of therapy for the management of IBS:
abnormal laboratory tests at screening, after one repeat laboratory test if allowed by the Medical Monitor, including the following:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive placebo in Part A and Placebo or Camlipixant in Part B.
Drug: Placebo · Drug: Camlipixant
Participants will receive Camlipixant dose level 1 in Part A and Placebo or Camlipixant in Part B.
Drug: Placebo · Drug: Camlipixant
Participants will receive Camlipixant dose level 2 in Part A and Placebo or Camlipixant in Part B.
Drug: Placebo · Drug: Camlipixant
Participants will receive Camlipixant dose level 3 in Part A and Placebo or Camlipixant in Part B
Drug: Placebo · Drug: Camlipixant
Placebo to be administered
Camlipixant to be administered
Change from Baseline in Weekly Abdominal pain intensity (API) over Weeks 7 to 12
Participants rate their pain intensity daily on a numeric rating scale from 0 (no pain) to 10 (worst possible pain). Weekly API scores are derived by averaging daily API scores. Higher score indicates worst outcome. A repeated measures statistical analysis is applied to weekly scores, and the result for the Weeks 7 to 12 interval is obtained by averaging adjusted mean estimates for Weeks 7, 8, 9, 10, 11 and 12.
Time frame: Baseline, Weeks 7 to 12 (time - average)
Change from Baseline in weekly abdominal score over Weeks 7 to 12
Abdominal score is calculated by averaging scores for API, abdominal discomfort and abdominal bloating items of the Diary of Irritable Bowel Syndrome Symptoms-Mixed (DIBSS-M) and Diary of Irritable Bowel Syndrome Symptoms- Diarrhea (DIBSS-D). Each symptom is rated on a 0 (no symptoms) - 10 (worst imaginable severity) numeric rating scale. Higher scores indicate greater symptom severity. A repeated measures statistical analysis is applied to weekly scores, and the result for the Weeks 7 to 12 interval is obtained by averaging adjusted mean estimates for Weeks 7, 8, 9, 10, 11 and 12.
Time frame: Baseline, Weeks 7 to 12 (time - average)
Percentage of API responders up to Week 12
API response: achieving 30 percent (%) reduction in API for greater than or equal to (\>=)50% of weekly scores up to Week 12
Time frame: Up to Week 12
Change from Baseline in Weekly API over Weeks 7 to 12 (IBS-D participants)
The DIBSS-D is a patient-reported outcome instrument used to track symptom severity in adults with diarrhea-predominant IBS (IBS-D). Each symptom is rated on a 0 (no symptoms) - 10 (worst imaginable severity) numeric rating scale, where higher scores indicate greater symptom severity. A repeated measures statistical analysis is applied to weekly scores, and the result for the Weeks 7 to 12 interval is obtained by averaging adjusted mean estimates for Weeks 7, 8, 9, 10, 11 and 12.
Time frame: Baseline, Weeks 7 to 12 (time - average)
Change from Baseline in Bristol Stool Form Scale (BSFS) over Weeks 7 to 12 (IBS-D participants)
The BSFS is a widely used 7-point ordinal scale of stool types, rated by the participant based on written and pictorial representations, ranging from the hardest (Type 1, hard lumps) to the softest (Type 7, watery diarrhea). Higher score indicates worst outcome. A repeated measures statistical analysis is applied to weekly scores, and the result for the Weeks 7 to 12 interval is obtained by averaging adjusted mean estimates for Weeks 7, 8, 9, 10, 11 and 12.
Time frame: Baseline, Weeks 7 to 12 (time - average)
Percentage of API and Global Improvement Scale (GIS) responders (composite response) up to Week 12
The GIS is a 7-point single item participant rated likert scale which asks participants to rate their IBS symptoms over the previous 7 days using the below scale: Significantly relieved, moderately relieved, slightly relieved, Unchanged, Slightly worse, Moderately worse, Significantly worse. Higher score indicates worst outcome. API and GIS composite response: achieving significantly relieved or moderately relieved on GIS and decrease in weekly API of at least 30% compared with Baseline for \>=50% of weekly scores up to Week 12.
Time frame: Baseline and up to Week 12
Number of Participants With Treatment-emergent Adverse events (TEAEs) for both IBS-D and IBS-M
Number of participants with TEAEs, for both IBS-D and IBS-M will be presented part wise.
Time frame: Up to Week 26
Number of Participants with Serious Adverse Events (SAEs) for both IBS-D and IBS-M
Number of participants with SAEs for both IBS-D and IBS-M will be presented part wise.
Time frame: Up to Week 26
Number of Participants with Adverse Events of Special Interest (AESIs) for both IBS-D and IBS-M
Number of participants with AESIs for both IBS-D and IBS-M will be presented part wise.
Time frame: Up to Week 26
Number of Participants With Discontinuation due to Adverse Events for both IBS-D and IBS-M
Number of participants with discontinuation due to adverse events for both IBS-D and IBS-M will be presented part wise.
Time frame: Up to Week 26
Number of IBS-D and IBS-M participants with pre specified changes in blood pressure
Number of IBS-D and IBS-M participants with pre specified changes in blood pressure will be presented part wise.
Time frame: Up to Week 26
Number of IBS-D and IBS-M participants with pre specified changes in body temperature
Number of IBS-D and IBS-M participants with pre specified changes in body temperature will be presented part wise.
Time frame: Up to Week 26
Number of IBS-D and IBS-M participants with pre specified changes in heart rate
Number of IBS-D and IBS-M participants with pre specified changes in heart rate will be presented part wise.
Time frame: Up to Week 26
Number of IBS-D and IBS-M participants with pre specified changes in respiratory rate
Number of IBS-D and IBS-M participants with pre specified changes in respiratory rate will be presented part wise.
Time frame: Up to Week 26
Number of IBS-D and IBS-M participants with pre specified changes in Body Mass Index (BMI)
Number of IBS-D and IBS-M participants with pre specified changes in BMI will be presented part wise.
Time frame: Up to Week 26
Number of IBS-D and IBS-M participants with pre specified changes in Electrocardiogram (ECG) examinations
Number of IBS-D and IBS-M participants with pre specified changes in ECG examinations will be presented part wise.
Time frame: Up to Week 26
Number of IBS-D and IBS-M participants with pre specified changes in Laboratory parameters
Number of IBS-D and IBS-M participants with pre specified changes in Laboratory parameters will be presented part wise.
Time frame: Up to Week 26
Showing the first 100 of 114 sites. Choose a country and city above to see the rest.
Plan to share: Yes — Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://d3l8i7lo48obsd.cloudfront.net/gsk-patient-level-data-sharing-july2025-1-Bgwa1UthxvluYbWYTThw.pdf
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
Access criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.
Data sharing details ↗ · www.gsk-studyregister.com
No publications or documents are linked to this record.
Started Apr 2026 (actual). Primary completion is estimated for Mar 2027, 11 months after the start.
Of 24 industry-sponsored phase 2 interventional studies under Irritable Bowel Syndrome, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 23. This study's planned 11 months is below that.
Counting every sponsor, half of 42 studies reached it within 21 months; a quarter within 14 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: BLU-5937