Struggling with IBS Symptoms?
BALANCE Study
The BALANCE Study is testing a study drug called camlipixant in adults with 2 forms of irritable bowel syndrome (IBS-D or IBS-M). IBS-D involves mostly diarrhea, while IBS-M includes both diarrhea and constipation. Camlipixant is being tested to see if it can reduce the activation of nerves in the gut that trigger abdominal pain, stool irregularity, and overall IBS symptoms. During the study, camlipixant or placebo is taken as a tablet twice each day. It is hoped that camlipixant will help improve the quality of life of people affected by IBS-D and IBS-M. A placebo looks like the study drug but has no active ingredients. It is given to help researchers compare its effects to those of the actual drug, ensuring that the results are scientifically accurate and unbiased.
If you qualify and decide to take part, you may receive at no cost:
- The investigational oral study drug, which may reduce IBS symptoms or a placebo, which looks like the study drug but has no active ingredients
- Close study-related medical care and monitoring throughout the study
- Reimbursement for study-related time and expenses and a stipend for attending study visits and completion of study diaries
By joining the BALANCE Study, you’ll make a significant contribution to our understanding of treating IBS. Your experience may help others living with the same condition.
Who can participate in
this Study?
You may be able to join if you:
- Are 18-80 years old
- Have been diagnosed with IBS-D or IBS-M
- Are troubled by abdominal pain and abnormal stools
- Are willing to hold off certain IBS medications for the study
- Can use an electronic diary to track your symptoms daily
You will need to meet other requirements to join the BALANCE Study.
expect?
If you join the study, you’ll first have a 6 week ‘screening’ period of health checks, including a short period when you will begin to record your IBS symptoms in an electronic diary, or eDiary.
If the study is right for you, a computer program will be used to assign you to a treatment group by chance. You have approximately a 70% chance of being placed into a camlipixant treatment group and roughly a 30% chance of being placed into a placebo group.
The study treatment lasts 26 weeks during which the study doctors will determine how well camlipixant works in IBS. There will be a second random assignment during the study to further evaluate the effects of increasing dose, or switching to placebo, as well as long-term safety and effectiveness of the study drug.
What does “double-blind” mean?
The term “double-blind” means that neither you nor the study team know if you are receiving the study drug or placebo. This helps make the study results more reliable.
Study duration
The study lasts 34 weeks, and includes:
- Screening: Up to 6 weeks; 2 study visits. Start keeping track of IBS symptoms after second visit.
- Double-blind treatment period: Lasts 26 weeks to assess camlipixant’s benefits, with a second randomization to review different doses, placebo effects, and long-term safety.
- Follow-up: 2 weeks; 1 study visit (Week 28).
Irritable Bowel Syndrome
Irritable bowel syndrome, or IBS, is a condition with ongoing belly pain and changes in bowel habits—diarrhea, constipation, or both. You may also feel bloated, notice mucus in your stool, or feel like you haven’t finished a bowel movement. IBS does not cause visible damage to your digestive tract. Its cause is not fully understood, but it may involve how your brain and gut communicate, affecting how food moves through your system and causing discomfort.
There are 3 types of IBS: IBS-D (diarrhea), IBS-C (constipation), and IBS-M (mixed). IBS affects daily life, but most people manage symptoms with diet, stress reduction, and sometimes medication. The BALANCE Study is enrolling patients with IBS-D and IBS-M.
clinical study?
A clinical research study (also called a clinical trial or clinical study) is carefully supervised research that is done before an investigational drug (or study drug) becomes available to the public.
- Clinical studies follow specific rules to protect the safety, rights, well-being, and privacy of participants.
- The results help doctors and researchers decide if a medication or product is safe and should be available to patients.
- Clinical studies are the only way to develop new medical treatments to improve patient care.
Frequently asked questions
The study lasts 34 weeks, and includes:
- Screening: Up to 6 weeks; 2 study visits. Start keeping track of IBS symptoms after second visit.
- Double-blind treatment period Lasts 26 weeks to assess camlipixant’s benefits, with a second randomization to review different doses, placebo effects, and long-term safety.
- Follow-up: 2 weeks; 1 study visit
Camlipixant works by blocking the nerve signals in the digestive system that can cause IBS symptoms. The study drug or placebo is taken as a tablet, by mouth, twice each day.
Participants have the possibility to help advance knowledge about the treatment of IBS and potentially contribute to helping others living with IBS.
During this clinical study, participants will receive a supply of study medication at study visits and then take this twice daily at home. If you participate, you may also have the following procedures performed to monitor your health: vital signs, blood work, physical exams or other types of assessments that are necessary to gather the required information about the study medication. In the BALANCE study, participants may receive placebo (roughly a 30% chance of being placed into a placebo group). All study volunteers are always closely monitored by clinic staff and the medical team to ensure their safety.
Placebo: A placebo looks like the study drug but has no active ingredients. It is given to help researchers compare its effects to those of the actual drug, ensuring that the results are scientifically accurate and unbiased.
Participation in any clinical study is completely voluntary. Your decision to participate—or not participate—in this clinical study will have no effect on the medical care that you receive now or in the future. If you are eligible and choose to participate in the study, you may leave the clinical study at any time and for any reason.
GSK may reimburse all study participants for study-related travel and expenses and provide a stipend for attending study visits and completion of questionnaires (eDiary). For more information, please speak with a member of the study team during your study visits.
You’ll first be asked some general questions (here) that help us determine whether you meet the basic criteria of the study. If you do meet these criteria, you may be asked to attend a study visit. At that visit, you’ll be screened to see if you qualify for the study.
There are many reasons to participate in clinical research. For starters, it allows participants to play a more proactive role in their own health by receiving a new treatment for an ongoing disease or condition. Participants also play an important part in bringing much-needed drugs to market, benefiting thousands of people who also have the disease or condition. In many cases, this can be life changing.
Participants like you really help make a difference.
See if you prequalify for this research study.
Every clinical trial must be reviewed, and is continually monitored, by a regulatory review committee to ensure the risks are as low as possible and are worth any potential benefits to the study participant. As a volunteer, you have the right to discontinue your participation and leave the study at any time and for any reason, with no penalty or loss of benefits to which you are otherwise entitled.
GSK is responsible for conducting this clinical study.
