Clinical trial NCT04043455: Olorinab in Irritable Bowel Syndrome With Predominant Constipation (IBS-C) and Irritable Bowel Syndrome With Predominant Diarrhea (IBS-D)
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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Irritable Bowel Syndrome
Keywords: Abdominal pain
Olorinab
APD371
Irritable bowel syndrome (IBS)
IBS-C (IBS with predominant constipation)
IBS-D (IBS with predominant diarrhea)
Lead sponsor: Arena Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2019-08-02
Enrollment: 273
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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:

  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.

Primary outcomes:
measure: Main Study: Change From Baseline in Average Abdominal Pain Score (AAPS) at Week 12
timeFrame: Baseline and Week 12
measure: Main Study: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: Up to 14 Weeks
measure: LTE Period: Number of Participants With TEAEs and SAEs
timeFrame: Up to 54 Weeks
measure: Main Study: Number of Participants With Clinically Significant Abnormal Laboratory Parameters
timeFrame: Baseline to Week 14
measure: LTE Study: Number of Participants With Clinically Significant Abnormal Laboratory Parameters
timeFrame: Baseline to Week 54 (of LTE)
measure: Main Study: Number of Participants With Clinically Significant Abnormal Vital Signs
timeFrame: Baseline to Week 14
measure: LTE Study: Number of Participants With Clinically Significant Abnormal Vital Signs
timeFrame: Baseline to Week 54 (of LTE)
Secondary outcomes:
measure: Main Study: Percentage of Participants Achieving a Greater Than or Equal to (>=) 30% Improvement in AAPS at Week 12
timeFrame: Baseline and Week 12
measure: Main Study: Percentage of Participants Achieving a >= 30% Improvement in AAPS From Baseline for at Least 6 of the 12 Weeks
timeFrame: Baseline and Week 12
measure: Main Study: Percent Change From Baseline in AAPS at Week 12
timeFrame: Baseline and Week 12
measure: Main Study: Change From Baseline in Number of Pain-Free Days at Week 12
timeFrame: Baseline and Week 12
measure: Main Study: Maximum Concentration (Cmax) of Olorinab
timeFrame: 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
measure: Main Study: Time of Maximum Concentration After Drug Administration (Tmax) of Olorinab
timeFrame: 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
measure: Main Study: Plasma Trough Concentrations (Ctrough) of Olorinab
timeFrame: Pre dose on Day 1, Day 2 and Weeks 2, 4, 8, 10 and 12
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Accel Research Sites - Birmingham Clinical Research Unit
state: Alabama
city: Huntsville
country: United States
facility: Clinical Research Associates, LLC
state: Alabama
city: Chandler
country: United States
facility: East Valley Gastroenterology and Hepatology Associates
state: Arizona
city: Gilbert
country: United States
facility: Gilbert Center for Family Medicine
state: Arizona
city: Canoga Park
country: United States
facility: Alliance Research Institute
state: California
city: Chula Vista
country: United States
facility: GW Research, Inc.
state: California
city: Corona
country: United States
facility: Kindred Medical Institute for Clinical Trials, LLC
state: California
city: El Cajon
country: United States
facility: TriWest Research Associates, LLC
state: California
city: Encinitas
country: United States
facility: Diagnamics Inc.
state: California
city: Laguna Hills
country: United States
facility: Prime Care Clinical Research
state: California
city: Lancaster
country: United States
facility: Om Research, Attn: Heather Blunt
state: California
city: San Diego
country: United States
facility: San Diego Gastroenterology Medical Associates (CTNx)
state: California
city: San Diego
country: United States
facility: Precision Research Institute
state: California
city: San Diego
country: United States
facility: Medical Associates Research Group
state: California
city: Westminster
country: United States
facility: Advanced Rx Clinical Research Group, Inc.
state: California
city: Aurora
country: United States
facility: Lynn Institute of Denver
state: Colorado
city: Brandon
country: United States
facility: Clinical Research of Brandon, LLC
state: Florida
city: South Miami
country: United States
facility: Qps Mra, Llc
state: Florida
city: Sunrise
country: United States
facility: Precision Clinical Research, LLC.
state: Florida
city: Tampa
country: United States
facility: Presicion Research Center Inc
state: Florida
city: Atlanta
country: United States
facility: Agile Clinical Research Trials LLC
state: Georgia
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Columbus
country: United States
facility: Columbus Regional Research Institute
state: Georgia
city: Gainesville
country: United States
facility: Gastroenterology Associates of Gainesville Georgia
state: Georgia
city: Sandy Springs
country: United States
facility: WR-Mount Vernon Clinical Research, LLC
state: Georgia
city: Stockbridge
country: United States
facility: Clinical Research Atlanta
state: Georgia
city: Meridian
country: United States
facility: Advanced Clinical Research, Attn to: Owen Havey
state: Idaho
city: Chicago
country: United States
facility: Claude Mandel Medical Center
state: Illinois
city: Oakbrook Terrace
country: United States
facility: Lemah Creek Clinical Research
state: Illinois
city: Evansville
country: United States
facility: MediSphere Medical Research Center, LLC
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Shawnee Mission
country: United States
facility: WestGlenGI
state: Kansas
city: Houma
country: United States
facility: CroNOLA, LLC
state: Louisiana
city: Lake Charles
country: United States
facility: Clinical Trials of SWLA, LLC
state: Louisiana
city: Shreveport
country: United States
facility: Louisiana Research Center, LLC
state: Louisiana
city: Frederick
country: United States
facility: Frederick Gastroenterology Associates
state: Maryland
city: Flint
country: United States
facility: Flint Clinical Research, PLLC
state: Michigan
city: Kansas City
country: United States
facility: Center for Pharmaceutical Research, LLC an AMR company
state: Missouri
city: Berlin
country: United States
facility: Hassman Research Institute
state: New Jersey
city: Great Neck
country: United States
facility: Long Island Gastrointestinal Research Group LLP
state: New York
city: Gastonia
country: United States
facility: Clinical Research of Gastonia
state: North Carolina
city: Greensboro
country: United States
facility: Medication Management, LLC
state: North Carolina
city: High Point
country: United States
facility: Peters Medical Research, LLC
state: North Carolina
city: Raleigh
country: United States
facility: M3 Wake Research
state: North Carolina
city: Beachwood
country: United States
facility: Great Lakes Medical Research
state: Ohio
city: Cleveland
country: United States
facility: Rapid Medical Research, Inc.
state: Ohio
city: Mentor
country: United States
facility: Great Lakes Gastroenterology Research, LLC
state: Ohio
city: Wadsworth
country: United States
facility: Family Practice Center of Wadsworth, Inc. dba New Venture Medical Research
state: Ohio
city: Norman
country: United States
facility: Central Sooner Research
state: Oklahoma
city: Oklahoma City
country: United States
facility: Digestive Disease Specialists, Inc.
state: Oklahoma
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Tulsa
country: United States
facility: Lynn Institute of Tulsa
state: Oklahoma
city: Salem
country: United States
facility: Oregon Center for Clinical Investigations, Inc. (OCCI, Inc.)
state: Oregon
city: Harrisburg
country: United States
facility: Susquehanna Research Group, LLC
state: Pennsylvania
city: Pottsville
country: United States
facility: Care Access Research, Pottsville
state: Pennsylvania
city: Charleston
country: United States
facility: Clinical Trials of South Carolina
state: South Carolina
city: Mount Pleasant
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Rock Hill
country: United States
facility: Clinical Research of Rock Hill
state: South Carolina
city: Dakota Dunes
country: United States
facility: Meridian Clinical Research, LLC
state: South Dakota
city: Chattanooga
country: United States
facility: Chattanooga Research & Medicine, PLLC
state: Tennessee
city: Chattanooga
country: United States
facility: WR-ClinSearch, LLC
state: Tennessee
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Tennessee
city: Houston
country: United States
facility: Biopharma Informatic, LLC
state: Texas
city: Houston
country: United States
facility: Clinical Trial Network
state: Texas
city: Irving
country: United States
facility: Research Studies at Fine Digestive Health
state: Texas
city: West Jordan
country: United States
facility: ACR Gut Whisperer
state: Utah
city: Christiansburg
country: United States
facility: New River Valley Research Institute
state: Virginia
city: Tacoma
country: United States
facility: MultiCare Institute for Research & Innovation
state: Washington
city: Morgantown
country: United States
facility: Exemplar Research Inc
state: West Virginia
Study officials:
affiliation: Arena Pharmaceuticals
name: Arena CT.gov Administrator
role: STUDY_DIRECTOR
References: