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

Primary Purpose

Irritable Bowel Syndrome

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Olorinab
Olorinab
Olorinab
Placebo
Olorinab
Olorinab
Sponsored by
Arena Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Abdominal pain, Olorinab, APD371, Irritable bowel syndrome (IBS), IBS-C (IBS with predominant constipation), IBS-D (IBS with predominant diarrhea)

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Main Study Inclusion Criteria:

  • Diagnosis of irritable bowel syndrome (IBS) with predominant constipation (IBS-C) or predominant diarrhea (IBS-D) according to Rome IV criteria at Visit 1 (Screening)

  • Per the Rome IV diagnostic algorithm for IBS, participants 50 years of age and over are to have had one of the following with a result that rules out causes of abdominal pain other than IBS:

    1. Colonoscopy (within 10 years of Visit 1 [Screening])
    2. Flexible sigmoidoscopy and double contrast barium enema (within 5 years of Visit 1 [Screening])
    3. Computed tomography colonography (within 5 years of Visit 1 [Screening])

Main Study Exclusion Criteria:

  • Diagnosis of IBS with mixed bowel habits (IBS-M) or unsubtyped IBS (IBS-U)
  • Clinically relevant changes in dietary, lifestyle, or exercise regimen within 30 days prior to Visit 1 (Screening) that may confound efficacy assessments in the clinical judgment of the Investigator (or designee)
  • Any colonic or major abdominal surgery (eg, bariatric surgery [including gastric banding], stomach surgery, small/large bowel surgery, or abdominal large vessel surgery). History of cholecystectomy is exclusionary for participants with IBS-D. For participants with IBS-C, a history of cholecystectomy more than 6 months prior to Visit 1 (Screening) is allowed. Procedures such as appendectomy, hysterectomy, caesarean section, or polypectomy are allowed as long as they have occurred at least 3 months prior to Visit 1 (Screening).

Long-Term Extension Inclusion Criteria:

•All participants must have completed the Main Study (including both Visit 8 [Week 12] and Visit 9 [Week 14])

Long-Term Extension Exclusion Criteria:

  • Participant meets any exclusion criteria from the Main Study at the time of assessing eligibility for the LTE, unless approved by the Sponsor in advance.
  • Participant had less than 75% overall compliance with eDiary entries during the Main Study.
  • Participant deviated from the prescribed dosage regimen during the Main Study (ie, overall study treatment compliance less than 85% or more than 115%), unless approved by the Sponsor in advance.

Sites / Locations

  • Accel Research Sites - Birmingham Clinical Research Unit
  • Clinical Research Associates, LLC
  • East Valley Gastroenterology and Hepatology Associates
  • Gilbert Center for Family Medicine
  • Alliance Research Institute
  • GW Research, Inc.
  • Kindred Medical Institute for Clinical Trials, LLC
  • TriWest Research Associates, LLC
  • Diagnamics Inc.
  • Prime Care Clinical Research
  • Om Research, Attn: Heather Blunt
  • San Diego Gastroenterology Medical Associates (CTNx)
  • Precision Research Institute
  • Medical Associates Research Group
  • Advanced Rx Clinical Research Group, Inc.
  • Lynn Institute of Denver
  • Clinical Research of Brandon, LLC
  • Qps Mra, Llc
  • Precision Clinical Research, LLC.
  • Presicion Research Center Inc
  • Agile Clinical Research Trials LLC
  • Atlanta Center for Medical Research
  • Columbus Regional Research Institute
  • Gastroenterology Associates of Gainesville Georgia
  • WR-Mount Vernon Clinical Research, LLC
  • Clinical Research Atlanta
  • Advanced Clinical Research, Attn to: Owen Havey
  • Claude Mandel Medical Center
  • Lemah Creek Clinical Research
  • MediSphere Medical Research Center, LLC
  • University of Iowa Hospitals and Clinics
  • WestGlenGI
  • CroNOLA, LLC
  • Clinical Trials of SWLA, LLC
  • Louisiana Research Center, LLC
  • Frederick Gastroenterology Associates
  • Flint Clinical Research, PLLC
  • Center for Pharmaceutical Research, LLC an AMR company
  • Hassman Research Institute
  • Long Island Gastrointestinal Research Group LLP
  • Clinical Research of Gastonia
  • Medication Management, LLC
  • Peters Medical Research, LLC
  • M3 Wake Research
  • Great Lakes Medical Research
  • Rapid Medical Research, Inc.
  • Great Lakes Gastroenterology Research, LLC
  • Family Practice Center of Wadsworth, Inc. dba New Venture Medical Research
  • Central Sooner Research
  • Digestive Disease Specialists, Inc.
  • Lynn Health Science Institute
  • Lynn Institute of Tulsa
  • Oregon Center for Clinical Investigations, Inc. (OCCI, Inc.)
  • Susquehanna Research Group, LLC
  • Care Access Research, Pottsville
  • Clinical Trials of South Carolina
  • Coastal Carolina Research Center
  • Clinical Research of Rock Hill
  • Meridian Clinical Research, LLC
  • Chattanooga Research & Medicine, PLLC
  • WR-ClinSearch, LLC
  • Clinical Neuroscience Solutions, Inc.
  • Biopharma Informatic, LLC
  • Clinical Trial Network
  • Research Studies at Fine Digestive Health
  • ACR Gut Whisperer
  • New River Valley Research Institute
  • MultiCare Institute for Research & Innovation
  • Exemplar Research Inc

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Experimental

Arm Label

Olorinab low dose (Main Study)

Olorinab medium dose (Main Study)

Olorinab high dose (Main Study)

Placebo (Main Study)

Olorinab (Long-Term Extension)

Arm Description

Participants will receive olorinab based on their treatment assignment in the Main Study.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
August 1, 2019
Last Updated
September 15, 2022
Sponsor
Arena Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT04043455
Brief Title
Olorinab in Irritable Bowel Syndrome With Predominant Constipation (IBS-C) and Irritable Bowel Syndrome With Predominant Diarrhea (IBS-D)
Acronym
CAPTIVATE
Official Title
A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of Olorinab in Subjects With Irritable Bowel Syndrome Experiencing Abdominal Pain
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Terminated
Why Stopped
Business Decision
Study Start Date
July 24, 2019 (Actual)
Primary Completion Date
April 29, 2021 (Actual)
Study Completion Date
April 29, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arena Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
Abdominal pain, Olorinab, APD371, Irritable bowel syndrome (IBS), IBS-C (IBS with predominant constipation), IBS-D (IBS with predominant diarrhea)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
273 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Olorinab low dose (Main Study)
Arm Type
Experimental
Arm Title
Olorinab medium dose (Main Study)
Arm Type
Experimental
Arm Title
Olorinab high dose (Main Study)
Arm Type
Experimental
Arm Title
Placebo (Main Study)
Arm Type
Placebo Comparator
Arm Title
Olorinab (Long-Term Extension)
Arm Type
Experimental
Arm Description
Participants will receive olorinab based on their treatment assignment in the Main Study.
Intervention Type
Drug
Intervention Name(s)
Olorinab
Other Intervention Name(s)
APD371
Intervention Description
Olorinab Dose 1 capsule or tablet by mouth, 3 times per day up to 12 weeks
Intervention Type
Drug
Intervention Name(s)
Olorinab
Other Intervention Name(s)
APD371
Intervention Description
Olorinab Dose 2 capsule or tablet by mouth, 3 times per day up to 12 weeks
Intervention Type
Drug
Intervention Name(s)
Olorinab
Other Intervention Name(s)
APD371
Intervention Description
Olorinab Dose 3 capsule or tablet by mouth, 3 times per day up to 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Olorinab matching placebo capsule or tablet by mouth, 3 times per day up to 12 weeks
Intervention Type
Drug
Intervention Name(s)
Olorinab
Other Intervention Name(s)
APD371
Intervention Description
Olorinab Dose 2 capsule or tablet by mouth, 3 times per day up to 52 weeks
Intervention Type
Drug
Intervention Name(s)
Olorinab
Other Intervention Name(s)
APD371
Intervention Description
Olorinab Dose 3 capsule or tablet by mouth, 3 times per day up to 52 weeks
Primary Outcome Measure Information:
Title
Main Study: Change From Baseline in Average Abdominal Pain Score (AAPS) at Week 12
Description
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
Title
Main Study: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Description
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
Title
LTE Period: Number of Participants With TEAEs and SAEs
Description
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
Title
Main Study: Number of Participants With Clinically Significant Abnormal Laboratory Parameters
Description
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 14
Title
LTE Study: Number of Participants With Clinically Significant Abnormal Laboratory Parameters
Description
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)
Title
Main Study: Number of Participants With Clinically Significant Abnormal Vital Signs
Description
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
Title
LTE Study: Number of Participants With Clinically Significant Abnormal Vital Signs
Description
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)
Secondary Outcome Measure Information:
Title
Main Study: Percentage of Participants Achieving a Greater Than or Equal to (>=) 30% Improvement in AAPS at Week 12
Description
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
Title
Main Study: Percentage of Participants Achieving a >= 30% Improvement in AAPS From Baseline for at Least 6 of the 12 Weeks
Description
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
Title
Main Study: Percent Change From Baseline in AAPS at Week 12
Description
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
Title
Main Study: Change From Baseline in Number of Pain-Free Days at Week 12
Description
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
Title
Main Study: Maximum Concentration (Cmax) of Olorinab
Description
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
Title
Main Study: Time of Maximum Concentration After Drug Administration (Tmax) of Olorinab
Description
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
Title
Main Study: Plasma Trough Concentrations (Ctrough) of Olorinab
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main Study Inclusion Criteria: Diagnosis of irritable bowel syndrome (IBS) with predominant constipation (IBS-C) or predominant diarrhea (IBS-D) according to Rome IV criteria at Visit 1 (Screening) Per the Rome IV diagnostic algorithm for IBS, participants 50 years of age and over are to have had one of the following with a result that rules out causes of abdominal pain other than IBS: Colonoscopy (within 10 years of Visit 1 [Screening]) Flexible sigmoidoscopy and double contrast barium enema (within 5 years of Visit 1 [Screening]) Computed tomography colonography (within 5 years of Visit 1 [Screening]) Main Study Exclusion Criteria: Diagnosis of IBS with mixed bowel habits (IBS-M) or unsubtyped IBS (IBS-U) Clinically relevant changes in dietary, lifestyle, or exercise regimen within 30 days prior to Visit 1 (Screening) that may confound efficacy assessments in the clinical judgment of the Investigator (or designee) Any colonic or major abdominal surgery (eg, bariatric surgery [including gastric banding], stomach surgery, small/large bowel surgery, or abdominal large vessel surgery). History of cholecystectomy is exclusionary for participants with IBS-D. For participants with IBS-C, a history of cholecystectomy more than 6 months prior to Visit 1 (Screening) is allowed. Procedures such as appendectomy, hysterectomy, caesarean section, or polypectomy are allowed as long as they have occurred at least 3 months prior to Visit 1 (Screening). Long-Term Extension Inclusion Criteria: •All participants must have completed the Main Study (including both Visit 8 [Week 12] and Visit 9 [Week 14]) Long-Term Extension Exclusion Criteria: Participant meets any exclusion criteria from the Main Study at the time of assessing eligibility for the LTE, unless approved by the Sponsor in advance. Participant had less than 75% overall compliance with eDiary entries during the Main Study. Participant deviated from the prescribed dosage regimen during the Main Study (ie, overall study treatment compliance less than 85% or more than 115%), unless approved by the Sponsor in advance.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arena CT.gov Administrator
Organizational Affiliation
Arena Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Accel Research Sites - Birmingham Clinical Research Unit
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
Clinical Research Associates, LLC
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
East Valley Gastroenterology and Hepatology Associates
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Gilbert Center for Family Medicine
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85298
Country
United States
Facility Name
Alliance Research Institute
City
Canoga Park
State/Province
California
ZIP/Postal Code
91304
Country
United States
Facility Name
GW Research, Inc.
City
Chula Vista
State/Province
California
ZIP/Postal Code
91910
Country
United States
Facility Name
Kindred Medical Institute for Clinical Trials, LLC
City
Corona
State/Province
California
ZIP/Postal Code
92879
Country
United States
Facility Name
TriWest Research Associates, LLC
City
El Cajon
State/Province
California
ZIP/Postal Code
92020
Country
United States
Facility Name
Diagnamics Inc.
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Prime Care Clinical Research
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
Om Research, Attn: Heather Blunt
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Facility Name
San Diego Gastroenterology Medical Associates (CTNx)
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Precision Research Institute
City
San Diego
State/Province
California
ZIP/Postal Code
92114
Country
United States
Facility Name
Medical Associates Research Group
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Advanced Rx Clinical Research Group, Inc.
City
Westminster
State/Province
California
ZIP/Postal Code
92683
Country
United States
Facility Name
Lynn Institute of Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
Clinical Research of Brandon, LLC
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Qps Mra, Llc
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Precision Clinical Research, LLC.
City
Sunrise
State/Province
Florida
ZIP/Postal Code
33351
Country
United States
Facility Name
Presicion Research Center Inc
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
Agile Clinical Research Trials LLC
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Atlanta Center for Medical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Facility Name
Columbus Regional Research Institute
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Gastroenterology Associates of Gainesville Georgia
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
WR-Mount Vernon Clinical Research, LLC
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Clinical Research Atlanta
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Facility Name
Advanced Clinical Research, Attn to: Owen Havey
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Claude Mandel Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60617
Country
United States
Facility Name
Lemah Creek Clinical Research
City
Oakbrook Terrace
State/Province
Illinois
ZIP/Postal Code
60181
Country
United States
Facility Name
MediSphere Medical Research Center, LLC
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
WestGlenGI
City
Shawnee Mission
State/Province
Kansas
ZIP/Postal Code
66217
Country
United States
Facility Name
CroNOLA, LLC
City
Houma
State/Province
Louisiana
ZIP/Postal Code
70360
Country
United States
Facility Name
Clinical Trials of SWLA, LLC
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70601
Country
United States
Facility Name
Louisiana Research Center, LLC
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71105
Country
United States
Facility Name
Frederick Gastroenterology Associates
City
Frederick
State/Province
Maryland
ZIP/Postal Code
21701
Country
United States
Facility Name
Flint Clinical Research, PLLC
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
Facility Name
Center for Pharmaceutical Research, LLC an AMR company
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Facility Name
Hassman Research Institute
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Long Island Gastrointestinal Research Group LLP
City
Great Neck
State/Province
New York
ZIP/Postal Code
11023
Country
United States
Facility Name
Clinical Research of Gastonia
City
Gastonia
State/Province
North Carolina
ZIP/Postal Code
28054
Country
United States
Facility Name
Medication Management, LLC
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
Facility Name
Peters Medical Research, LLC
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
M3 Wake Research
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Great Lakes Medical Research
City
Beachwood
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Rapid Medical Research, Inc.
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Great Lakes Gastroenterology Research, LLC
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
Facility Name
Family Practice Center of Wadsworth, Inc. dba New Venture Medical Research
City
Wadsworth
State/Province
Ohio
ZIP/Postal Code
44281
Country
United States
Facility Name
Central Sooner Research
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73071
Country
United States
Facility Name
Digestive Disease Specialists, Inc.
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Lynn Health Science Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Lynn Institute of Tulsa
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74105
Country
United States
Facility Name
Oregon Center for Clinical Investigations, Inc. (OCCI, Inc.)
City
Salem
State/Province
Oregon
ZIP/Postal Code
97301
Country
United States
Facility Name
Susquehanna Research Group, LLC
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17110
Country
United States
Facility Name
Care Access Research, Pottsville
City
Pottsville
State/Province
Pennsylvania
ZIP/Postal Code
17901
Country
United States
Facility Name
Clinical Trials of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Coastal Carolina Research Center
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Clinical Research of Rock Hill
City
Rock Hill
State/Province
South Carolina
ZIP/Postal Code
29732
Country
United States
Facility Name
Meridian Clinical Research, LLC
City
Dakota Dunes
State/Province
South Dakota
ZIP/Postal Code
57049
Country
United States
Facility Name
Chattanooga Research & Medicine, PLLC
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
WR-ClinSearch, LLC
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Biopharma Informatic, LLC
City
Houston
State/Province
Texas
ZIP/Postal Code
77043
Country
United States
Facility Name
Clinical Trial Network
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Research Studies at Fine Digestive Health
City
Irving
State/Province
Texas
ZIP/Postal Code
75039
Country
United States
Facility Name
ACR Gut Whisperer
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
New River Valley Research Institute
City
Christiansburg
State/Province
Virginia
ZIP/Postal Code
24073
Country
United States
Facility Name
MultiCare Institute for Research & Innovation
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Exemplar Research Inc
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26505
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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