Effect of Olorinab on Gastrointestinal Transit in Patients With Irritable Bowel Syndrome
NCT ID: NCT04655599
Last Updated: 2021-05-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE1
1 participants
INTERVENTIONAL
2021-01-29
2021-04-13
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Olorinab in Irritable Bowel Syndrome With Predominant Constipation (IBS-C) and Irritable Bowel Syndrome With Predominant Diarrhea (IBS-D)
NCT04043455
A Comparison of the Effects of ORP-101 Versus Placebo in Adult Patients With Irritable Bowel Syndrome With Diarrhea (IBS-D)
NCT04129619
A Study of MD-7246 to Treat Abdominal Pain in Patients With Diarrhea-predominant Irritable Bowel Syndrome
NCT03931785
Feasibility and Reproducibility of Barostat Assessments of Colorectal Sensation During Colorectal Distention and Its Pharmacological Modulation Using Octreotide
NCT00584298
A Trial of Linaclotide 290 μg in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
NCT03573908
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
BASIC_SCIENCE
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Olorinab, Then Placebo
Participants will first receive olorinab, followed by a washout period, and they then will receive placebo.
Olorinab
Olorinab tablet by mouth, 3 times a day for 4 days with a final dose on Day 5.
Placebo
Olorinab matching placebo tablet by mouth, 3 times a day for 4 days with a final dose on Day 5.
Placebo, Then Olorinab
Participants will first receive placebo, followed by a washout period, and they then will receive olorinab.
Olorinab
Olorinab tablet by mouth, 3 times a day for 4 days with a final dose on Day 5.
Placebo
Olorinab matching placebo tablet by mouth, 3 times a day for 4 days with a final dose on Day 5.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Olorinab
Olorinab tablet by mouth, 3 times a day for 4 days with a final dose on Day 5.
Placebo
Olorinab matching placebo tablet by mouth, 3 times a day for 4 days with a final dose on Day 5.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Body mass index (BMI) 18.0 to 40.0 kilograms per square meter (kg/m\^2), inclusive at Screening
* Negative test results for alcohol and selected drugs at Screening and Day 1
* Negative hepatitis panel (including hepatitis B surface antigen \[HBsAg\] and hepatitis C virus antibody \[anti-HCV\]) and negative for human immunodeficiency virus (HIV) antibody screens at Screening
* Participants with recent (within 6 months of Screening) or ongoing alarm features (unexplained weight loss, nocturnal symptoms, blood mixed with stool) are to have had a diagnostic colonoscopy prior to Screening and after the onset of alarm features (for participants with alarm features) to exclude non-IBS conditions per the Rome IV diagnostic algorithm for IBS
Exclusion Criteria
* Structural or metabolic diseases/conditions that affect the gastrointestinal system
* Diagnosis of IBS with mixed bowel habits (IBS-M) or unsubtyped IBS (IBS-U)
* Unable to withdraw medications that alter gastrointestinal (GI) transit for 72 hours prior to baseline colonic transit assay through the duration of treatment period, with the exception of rescue medicine usage (bisacodyl and loperamide)
* Clinically relevant changes in dietary, lifestyle, or exercise regimen within 30 days prior to Screening and for the duration of the study that may confound efficacy assessments in the clinical judgment of the Investigator (or designee)
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Arena Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Arena CT.gov Administrator
Role: STUDY_DIRECTOR
Arena Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Mayo Clinic
Rochester, Minnesota, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
APD371-106
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.