A 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)

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorGlaxoSmithKline

About this trial

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.

Eligibility criteria

Qualifiers

Male or female aged 18 to 80 years inclusive, at the time of signing the Informed consent form (ICF).

Diagnosis of IBS-D or IBS-M according to the Rome IV criteria at screening

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

Disqualifiers

Diagnosis of Irritable bowel syndrome - constipation (IBS-C) or Irritable bowel syndrome - unclassified (IBS-U)

History or presence of inflammatory or immune-mediated Gastrointestinal (GI) disorders 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 bile salt diarrhea

Trial design

Treatments tested in this trial

  • Placebo
  • Camlipixant

Treatment groups

420 Participants
are divided into 4 treatment groups

Sponsors and collaborators