RecruitingPhase 2interventionalRules rewrite

Phase 2: testing Placebo for Irritable Bowel Syndrome

This study is designed to measure the how well it works and safety of camlipixant in adults with IBS-D and IBS-M. After the first part, some you would be randomly chosen again to either get a higher dose or stop the drug.

Official registry: https://clinicaltrials.gov/study/NCT07519395 · GlaxoSmithKline · enrollment listed as 420

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Placebo, or Camlipixant. The registry lists allocation as randomized. This study is designed to measure the how well it works and safety of camlipixant in adults with IBS-D and IBS-M.

They plan to enroll about 420 people at 94 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

BALANCE - A Two-part, 26-week, Randomized, Double-Blind, Dose-rAnging, pLAcebo-coNtrolled, Phase 2b Study to Evaluate the effiCacy and safEty of Camlipixant in Adults With IBS-D and IBS-M

Interventions: Placebo, Camlipixant

Primary outcome (registry wording): Change from Baseline in Weekly Abdominal pain intensity (API) over Weeks 7 to 12

Who it is for (from inclusion criteria)

Ages 18 Years to 80 Years
Diagnosis of IBS-D or IBS-M according to the Rome IV V criteria at screening with documented IBS symptoms onset at least 6 months prior to the diagnosis
Moderate or severe irritable bowel syndrome (IBS) based on Irritable bowel syndrome Severity Scoring System (IBS SSS) at screening visit
Weekly API score \>=4.0 in each week of the run-in period
IBS-D: at least one stool with BSFS Type 6 or 7 consistency on at least 2 days in each week of the run-in period
IBS-M: an average of at least 2 days per week with abnormal bowel movements (BSFS Type 1, 2, 6, or 7) during the run-in period, and greater than (\>)25% of abnormal bowel movements must be Type 6 or 7 and \>25% Type 1 or 2

Who the registry excludes

Diagnosis of Irritable bowel syndrome - constipation (IBS-C) or Irritable bowel syndrome - unclassified (IBS-U)
History or presence of inflammatory or immune-mediated disorders of the small or large intestine e.g. inflammatory bowel disease, microscopic colitis, or celiac disease
History or presence of GI infection (confirmed with stool culture) within 3 months prior to screening
History or presence of small intestinal bacterial overgrowth within 6 months prior to screening
History or presence of bile salt diarrhea
Prior use of more than two of the following therapies or classes of therapy for the management of IBS:
Antidepressants or neuromodulators (e.g., Tricyclic antidepressant \[TCAs\], Selective serotonin reuptake inhibitor \[SSRIs\], gabapentinoids)

Public study contact (from the registry)

US GSK Clinical Trials Call Center

877-379-3718

GSKClinicalSupportHD@gsk.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

94 listed

GSK Investigational Site — Anniston, Alabama (recruiting)
GSK Investigational Site — Guntersville, Alabama (recruiting)
GSK Investigational Site — Mobile, Alabama (recruiting)
GSK Investigational Site — Saraland, Alabama (recruiting)
GSK Investigational Site — Phoenix, Arizona (recruiting)
GSK Investigational Site — Scottsdale, Arizona (recruiting)
GSK Investigational Site — Tempe, Arizona (recruiting)
GSK Investigational Site — Tucson, Arizona (recruiting)
GSK Investigational Site — Anaheim, California (recruiting)
GSK Investigational Site — Chula Vista, California (recruiting)
GSK Investigational Site — Coronado, California (recruiting)
GSK Investigational Site — Garden Grove, California (recruiting)

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NCT05519683 · Official ClinicalTrials.gov record · University of Michigan

FAQ about this NCT record

Is NCT07519395 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07519395?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07519395?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary