The purpose of this study is to determine whether olorinab is a safe and effective treatment for abdominal pain in participants with irritable bowel syndrome (IBS).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
273
Main Study: Change From Baseline in Average Abdominal Pain Score (AAPS) at Week 12
The APS is a single question, 11-point numeric rating scale in which 0 represents no abdominal pain and 10 represents the worst possible abdominal pain. The change in AAPS from Baseline at Week 12 was analyzed using a mixed-effects model repeated measures (MMRM) analysis with treatment, stratification factors, week, and treatment-by-week interaction as factors and Baseline AAPS as a covariate. An unstructured variance-covariance matrix was used for the MMRM analysis.
Time frame: Baseline and Week 12
Main Study: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
An adverse event (AE) was any untoward medical occurrence in a participant administered a medicinal product without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were defined as any AE that started or worsened in severity on or after the first dose of study treatment.
Time frame: Up to 14 Weeks
LTE Period: Number of Participants With TEAEs and SAEs
An AE was any untoward medical occurrence in a participant administered a medicinal product without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were defined as any AE that started or worsened in severity on or after the first dose of study treatment.
Time frame: Up to 54 Weeks
Main Study: Number of Participants With Clinically Significant Abnormal Laboratory Parameters
Blood samples were collected for the analysis of laboratory parameters including serum chemistry, hematology, coagulation, and urinalysis. The investigator was responsible for reviewing laboratory results for clinically significant abnormalities.
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Olorinab matching placebo capsule or tablet by mouth, 3 times per day up to 12 weeks
Olorinab Dose 2 capsule or tablet by mouth, 3 times per day up to 52 weeks
Olorinab Dose 3 capsule or tablet by mouth, 3 times per day up to 52 weeks
Accel Research Sites - Birmingham Clinical Research Unit
Birmingham, Alabama, United States
Clinical Research Associates, LLC
Huntsville, Alabama, United States
East Valley Gastroenterology and Hepatology Associates
Chandler, Arizona, United States
Gilbert Center for Family Medicine
Gilbert, Arizona, United States
Alliance Research Institute
Canoga Park, California, United States
GW Research, Inc.
Chula Vista, California, United States
Kindred Medical Institute for Clinical Trials, LLC
Corona, California, United States
TriWest Research Associates, LLC
El Cajon, California, United States
Diagnamics Inc.
Encinitas, California, United States
Prime Care Clinical Research
Laguna Hills, California, United States
...and 59 more locations
Time frame: Baseline to Week 14
LTE Study: Number of Participants With Clinically Significant Abnormal Laboratory Parameters
Blood samples were collected for the analysis of laboratory parameters including serum chemistry, hematology, coagulation, and urinalysis. The investigator was responsible for reviewing laboratory results for clinically significant abnormalities.
Time frame: Baseline to Week 54 (of LTE)
Main Study: Number of Participants With Clinically Significant Abnormal Vital Signs
Parameters assessed for vital signs included blood pressure (systolic and diastolic blood pressure), heart rate (HR), body temperature, and respiratory rate. The investigator was responsible for reviewing vital signs for clinically significant abnormalities.
Time frame: Baseline to Week 14
LTE Study: Number of Participants With Clinically Significant Abnormal Vital Signs
Parameters assessed for vital signs included blood pressure (systolic and diastolic blood pressure), HR, body temperature, and respiratory rate. The investigator was responsible for reviewing vital signs for clinically significant abnormalities.
Time frame: Baseline to Week 54 (of LTE)
Main Study: Percentage of Participants Achieving a Greater Than or Equal to (>=) 30% Improvement in AAPS at Week 12
The percentage of participants achieving a \>= 30% improvement in AAPS from Baseline at Week 12 was analyzed using a Cochran-Mantel-Haenszel (CMH) test stratified by the stratification factors. Missing post-baseline AAPS data was imputed using multiple imputation (MI) under the missing at random (MAR) assumption. Participants who were randomized but did not have at least 1 post-Baseline observation were considered non-responders. A \>= 30% improvement in AAPS was a reduction in AAPS of 30% or more when compared to Baseline AAPS.
Time frame: Baseline and Week 12
Main Study: Percentage of Participants Achieving a >= 30% Improvement in AAPS From Baseline for at Least 6 of the 12 Weeks
The percentage of participants achieving a \>= 30% improvement in AAPS from Baseline for at least 6 of the 12 weeks during the Treatment Period were analyzed using a CMH test stratified by the stratification factors. A \>= 30% improvement in AAPS is a reduction in AAPS of 30% or more when compared to Baseline AAPS. Missing post-baseline AAPS data was imputed using MI under the MAR assumption.
Time frame: Baseline and Week 12
Main Study: Percent Change From Baseline in AAPS at Week 12
The percent change in AAPS from Baseline at Week 12 was analyzed using an MMRM analysis with treatment, stratification factors, week, and treatment-by-week interaction as factors and Baseline AAPS as a covariate. Baseline is the last non-missing measurement collected prior to the first dose of study treatment at Day 1.
Time frame: Baseline and Week 12
Main Study: Change From Baseline in Number of Pain-Free Days at Week 12
The change from Baseline at Week 12 in number of pain-free days per week was analyzed using a MMRM analysis with treatment, stratification factors, week, and treatment-by-week interaction as factors and Baseline pain free days as a covariate. Pain-free days were defined as days with a pain score of zero (0). Baseline is the last non-missing measurement collected prior to the first dose of study treatment at Day 1.
Time frame: Baseline and Week 12
Main Study: Maximum Concentration (Cmax) of Olorinab
Blood samples were collected from participants at indicated timepoints after the administration of study treatment to investigate Cmax of Olorinab. Pharmacokinetic (PK) analysis was conducted using standard non-compartmental methods.
Time frame: On Day 1: Pre-dose and 0.5, 1, 2, 4, and 8 hours post dose and Week 4: Pre-dose and 0.5, 1 and 2 hours post dose
Main Study: Time of Maximum Concentration After Drug Administration (Tmax) of Olorinab
Blood samples were collected from participants at indicated timepoints after the administration of study treatment to investigate Tmax of Olorinab. PK analysis was conducted using standard non-compartmental methods.
Time frame: On Day 1: Pre-dose and 0.5, 1, 2, 4, and 8 hours post dose and Week 4: Pre-dose and 0.5, 1 and 2 hours post dose
Main Study: Plasma Trough Concentrations (Ctrough) of Olorinab
Blood samples were collected from participants at indicated time frames after the administration of study treatment to investigate Ctrough of Olorinab. PK analysis was conducted using standard non-compartmental methods.
Time frame: Pre dose on Day 1, Day 2 and Weeks 2, 4, 8, 10 and 12