Trial · NCT04043455

Olorinab in Irritable Bowel Syndrome With Predominant Constipation (IBS-C) and Irritable Bowel Syndrome With Predominant Diarrhea (IBS-D)

NCT04043455, Phase 2, Terminated, Arena Pharmaceuticals; results first posted 2022-10-12

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Olorinab in Irritable Bowel Syndrome With Predominant Constipation (IBS-C) and Irritable Bowel Syndrome With Predominant Diarrhea (IBS-D). Trials, record NCT04043455. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04043455

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Olorinab in Irritable Bowel Syndrome With Predominant Constipation (IBS-C) and Irritable Bowel Syndrome With Predominant Diarrhea (IBS-D)
NCT number: NCT04043455
Status: Terminated
Phases: Phase 2
Enrollment: 273 participants, actual
Lead sponsor: Arena Pharmaceuticals
Conditions: Irritable Bowel Syndrome
Interventions: Olorinab, Olorinab, Olorinab, Placebo, Olorinab, Olorinab
First posted: 2019-08-02
Last updated: 2025-01-30
Results first posted: 2022-10-12

Source ClinicalTrials.gov

Registered outcomes14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Main Study: Change From Baseline in Average Abdominal Pain Score (AAPS) at Week 12	Baseline and 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.
Primary	Main Study: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	Up to 14 Weeks	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.
Primary	LTE Period: Number of Participants With TEAEs and SAEs	Up to 54 Weeks	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.
Primary	Main Study: Number of Participants With Clinically Significant Abnormal Laboratory Parameters	Baseline to Week 14	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.
Primary	LTE Study: Number of Participants With Clinically Significant Abnormal Laboratory Parameters	Baseline to Week 54 (of LTE)	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.
Primary	Main Study: Number of Participants With Clinically Significant Abnormal Vital Signs	Baseline to Week 14	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.
Primary	LTE Study: Number of Participants With Clinically Significant Abnormal Vital Signs	Baseline to Week 54 (of LTE)	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.
Secondary	Main Study: Percentage of Participants Achieving a Greater Than or Equal to (>=) 30% Improvement in AAPS at Week 12	Baseline and 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.
Secondary	Main Study: Percentage of Participants Achieving a >= 30% Improvement in AAPS From Baseline for at Least 6 of the 12 Weeks	Baseline and Week 12	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.
Secondary	Main Study: Percent Change From Baseline in AAPS at Week 12	Baseline and 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.

1 to 10 of 14Source ClinicalTrials.gov

See all 14 registered outcomes

Outcomes14

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Main Study: Change From Baseline in Average Abdominal Pain Score (AAPS) at Week 12	Baseline and Week 12	Main Study Full Analysis Set. Only those participants with data available at the specified timepoints were analyzed.	Scores on a scale	LEAST_SQUARES_MEAN
PRIMARY	Main Study: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	Up to 14 Weeks	Main Study Safety Set comprises of participants randomly assigned to study treatment and who took at least one dose of study treatment.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	LTE Period: Number of Participants With TEAEs and SAEs	Up to 54 Weeks	LTE Period Safety Set comprises of participants randomly assigned to study treatment and who took at least one dose of study treatment in the LTE Period.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Main Study: Number of Participants With Clinically Significant Abnormal Laboratory Parameters	Baseline to Week 14	Main Study Safety Set.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	LTE Study: Number of Participants With Clinically Significant Abnormal Laboratory Parameters	Baseline to Week 54 (of LTE)	LTE Safety Set.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Main Study: Number of Participants With Clinically Significant Abnormal Vital Signs	Baseline to Week 14	Main Study Safety Set.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	LTE Study: Number of Participants With Clinically Significant Abnormal Vital Signs	Baseline to Week 54 (of LTE)	LTE Safety Set.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Main Study: Percentage of Participants Achieving a Greater Than or Equal to (>=) 30% Improvement in AAPS at Week 12	Baseline and Week 12	Main Study Full Analysis Set.	Percentage of participants	NUMBER
SECONDARY	Main Study: Percentage of Participants Achieving a >= 30% Improvement in AAPS From Baseline for at Least 6 of the 12 Weeks	Baseline and Week 12	Main Study Full Analysis Set.	Percentage of participants	NUMBER
SECONDARY	Main Study: Percent Change From Baseline in AAPS at Week 12	Baseline and Week 12	Main Study Full Analysis Set. Only those participants with data available at the specified timepoints were analyzed.	Percent change	LEAST_SQUARES_MEAN

1 to 10 of 14Source ClinicalTrials.gov

See all 14 outcomes

Results by group77

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Main Study: Change From Baseline in Average Abdominal Pain Score (AAPS) at Week 12	Main Study Period: Olorinab 10 mg		-2.32	Standard Error 0.293	Scores on a scale
Main Study: Change From Baseline in Average Abdominal Pain Score (AAPS) at Week 12	Main Study Period: Olorinab 25 mg		-2.45	Standard Error 0.297	Scores on a scale
Main Study: Change From Baseline in Average Abdominal Pain Score (AAPS) at Week 12	Main Study Period: Olorinab 50 mg		-2.68	Standard Error 0.285	Scores on a scale
Main Study: Change From Baseline in Average Abdominal Pain Score (AAPS) at Week 12	Main Study Period: Placebo		-2.14	Standard Error 0.289	Scores on a scale
Main Study: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	Main Study Period: Olorinab 10 mg	Any TEAEs	34		Participants
Main Study: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	Main Study Period: Olorinab 25 mg	Any TEAEs	33		Participants
Main Study: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	Main Study Period: Olorinab 50 mg	Any TEAEs	31		Participants
Main Study: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	Main Study Period: Placebo	Any TEAEs	35		Participants
Main Study: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	Main Study Period: Olorinab 10 mg	Any SAEs	0		Participants
Main Study: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	Main Study Period: Olorinab 25 mg	Any SAEs	0		Participants

1 to 10 of 77Source ClinicalTrials.gov

See all 77 results by group

Participant flow48

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Main Study Double-Blind Treatment Period	STARTED	Main Study Period: Olorinab 10 mg	67
Main Study Double-Blind Treatment Period	STARTED	Main Study Period: Olorinab 25 mg	67
Main Study Double-Blind Treatment Period	STARTED	Main Study Period: Olorinab 50 mg	69
Main Study Double-Blind Treatment Period	STARTED	Main Study Period: Placebo	70
Main Study Double-Blind Treatment Period	STARTED	LTE Period: Olorinab 25 mg	0
Main Study Double-Blind Treatment Period	STARTED	LTE Period: Olorinab 50 mg	0
Main Study Double-Blind Treatment Period	Received Treatment	Main Study Period: Olorinab 10 mg	67
Main Study Double-Blind Treatment Period	Received Treatment	Main Study Period: Olorinab 25 mg	66
Main Study Double-Blind Treatment Period	Received Treatment	Main Study Period: Olorinab 50 mg	69
Main Study Double-Blind Treatment Period	Received Treatment	Main Study Period: Placebo	70

1 to 10 of 48Source ClinicalTrials.gov

See all 48 participant flow

Adverse events912

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Nasopharyngitis	Infections and infestations	Main Study Period: Olorinab 10 mg	5	67
other	Nasopharyngitis	Infections and infestations	Main Study Period: Olorinab 25 mg	1	66
other	Nasopharyngitis	Infections and infestations	Main Study Period: Olorinab 50 mg	3	69
other	Nasopharyngitis	Infections and infestations	Main Study Period: Placebo	1	70
other	Nasopharyngitis	Infections and infestations	LTE Period: Olorinab 25 mg	1	53
other	Nasopharyngitis	Infections and infestations	LTE Period: Olorinab 50 mg	1	51
other	Upper respiratory tract infection	Infections and infestations	Main Study Period: Olorinab 10 mg	1	67
other	Upper respiratory tract infection	Infections and infestations	Main Study Period: Olorinab 25 mg	0	66
other	Upper respiratory tract infection	Infections and infestations	Main Study Period: Olorinab 50 mg	5	69
other	Upper respiratory tract infection	Infections and infestations	Main Study Period: Placebo	1	70

1 to 10 of 912Source ClinicalTrials.gov

See all 912 adverse events

Adverse event totals18

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Main Study Period: Olorinab 10 mg	0	67
Total, all-cause mortality	Main Study Period: Olorinab 25 mg	0	66
Total, all-cause mortality	Main Study Period: Olorinab 50 mg	0	69
Total, all-cause mortality	Main Study Period: Placebo	0	70
Total, all-cause mortality	LTE Period: Olorinab 25 mg	0	53
Total, all-cause mortality	LTE Period: Olorinab 50 mg	0	51
Total, other adverse events	Main Study Period: Olorinab 10 mg	34	67
Total, other adverse events	Main Study Period: Olorinab 25 mg	33	66
Total, other adverse events	Main Study Period: Olorinab 50 mg	31	69
Total, other adverse events	Main Study Period: Placebo	35	70

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
36740814	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
LTE Period: Olorinab 25 mg vs LTE Period: Olorinab 50 mg: LTE Study: Number of Participants With Clinically Significant Abnormal Laboratory Parameters	Trial comparisons
LTE Period: Olorinab 25 mg vs LTE Period: Olorinab 50 mg: LTE Study: Number of Participants With Clinically Significant Abnormal Vital Signs	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04043455

GET https://conductscience.org/api/trials/v1/NCT04043455/results?page=2

API reference For AI assistants