Efficacy of Eluxadoline in the Treatment of Irritable Bowel Syndrome With Diarrhea in Patients With Inadequate Control of Symptoms With Prior Loperamide Use

NCT02959983 | Completed Phase 4 Results FDA Drug

• 1 other identifier: CMO-US-GI-0429
• Study Type: interventional
• Target: 346
• Locations: 2 countries
• Sites: 83

Brief Summary

This study will evaluate the efficacy and safety of eluxadoline 100 milligrams (mg) twice a day (BID) versus placebo for the treatment of patients with Irritable Bowel Syndrome with Diarrhea (IBS-D) who report that the use of loperamide in the prior 12 months failed to provide control of their IBS-D symptoms.

Conditions

Irritable Bowel Syndrome With Diarrhea

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Were Composite Responders Based on Improvements From Baseline in Daily Worst Abdominal Pain And Daily Stool Consistency Scores

  Percentage of primary composite responders is defined as the percentage of participants who meet both of the following daily composite criteria for at least 50% of the days with diary entry: 1)Worst Abdominal Pain (WAP) score improved by ≥40% compared to Baseline. The participant records their WAP score in the past 24 hours each day in a daily patient diary where: 0=no pain to 10=worst imaginable pain. 2) Bristol Stool Score (BSS) \<5; or the absence of a bowel movement if accompanied by ≥40% improvement in WAP compared to Baseline. The participant records their stool consistency each day in a daily patient diary using the BSS on a scale from 1 (hard stool) to 7 (watery stool).

  Baseline, Weeks 1 to 12

Secondary Outcomes (3)

• Percentage of Stool Consistency Responders

  Weeks 1 to 12 and 4-week intervals (Weeks 1 to 4, Weeks 5 to 8 and Weeks 9 to 12)

• Percentage of Pain Responders

  Baseline, Weeks 1 to 12 and 4-week intervals (Weeks 1 to 4, Weeks 5 to 8 and Weeks 9 to 12)

• Percentage of Monthly Composite Responders

  Weeks 1 to 4, 5 to 8, and 9 to 12

Study Arms (2)

Eluxadoline

ACTIVE COMPARATOR

Eluxadoline 100 mg oral tablets twice daily (BID) with food for 12 weeks.

Drug: Eluxadoline

Placebo

PLACEBO COMPARATOR

Placebo matching eluxadoline oral tablets BID with food for 12 weeks.

Drug: Placebo

Interventions

Eluxadoline DRUG

Eluxadoline 100 mg oral tablets BID with food.

Also known as: VIBERZI™

Eluxadoline

Placebo DRUG

Placebo matching eluxadoline oral tablets BID with food.

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has a diagnosis of IBS-D, defined by the Rome III criteria as loose (mushy) or watery stools ≥25% and hard or lumpy stools ≤25% of bowel movements.
• Has had a colonoscopy performed within 5 years prior to Screening if they are at least 50 years of age, OR if they meet any of the following alarm features:
• Has documented weight loss within the past 6 months; or
• Has nocturnal symptoms; or
• Has a familial history of colon cancer; or
• Has blood mixed with their stool (excluding any blood from hemorrhoids)
• Patient reports use of loperamide in the 12 months prior to Screening for IBS-D symptoms and that loperamide did not provide adequate control of IBS-D symptoms.
• Has not used any loperamide rescue medication within 14 days prior to randomization.

You may not qualify if:

• Has a diagnosis of Irritable Bowel Syndrome (IBS) with a subtype of constipation IBS, mixed IBS, or unsubtyped IBS.
• Has a history of inflammatory or immune-mediated gastrointestinal (GI) disorders including inflammatory bowel disease (i.e., Crohn's disease, ulcerative colitis), microscopic colitis, or celiac disease.
• Has a history of diverticulitis within 3 months prior to screening.
• Has a documented history of lactose intolerance.
• Has a documented history of bile-acid malabsorption.
• Has a history of chronic or severe constipation or intestinal obstruction, stricture, toxic megacolon, GI perforation, fecal impaction, gastric banding, bariatric surgery, adhesions.
• Has any of the following surgical history:
• Cholecystectomy or previously documented agenesis of gallbladder; or
• Any abdominal surgery within the 3 months prior to screening; or
• Major gastric, hepatic, pancreatic, or intestinal surgery (appendectomy, hemorrhoidectomy, or polypectomy greater than 3 months post-surgery are allowed).
• Has a history of cholecystitis within 6 months before screening.
• Has a history of pancreatitis or structural diseases of the pancreas, including known or suspected pancreatic duct obstruction.
• Has a history of known or suspected biliary duct obstruction or sphincter of Oddi disease or dysfunction, excluding a history of gallstones.
• Has a history or current evidence of laxative abuse within 5 years prior to screening.
• Has documented evidence of cirrhosis.

Sponsors & Collaborators

• Allergan: lead

Study Sites (83)

Clinical Research Associates, LLC

Huntsville, Alabama, 35801, United States

Location

The Center for Clinical Trials

Saraland, Alabama, 36571, United States

Location

Elite Clinical Studies

Phoenix, Arizona, 85018, United States

Location

Arkansas Gastroenterology

North Little Rock, Arkansas, 72117, United States

Location

Med Investigations

Carmichael, California, 95608, United States

Location

GW Research Inc

Chula Vista, California, 91910, United States

Location

Diagnamics Inc

Encinitas, California, 92024, United States

Location

Behavioral Research Specialists, LLC

Irvine, California, 92606, United States

Location

Providence Clinical Research

North Hollywood, California, 91606, United States

Location

Shahram Jacobs MD INC.

Sherman Oaks, California, 91403, United States

Location

Westlake Medical Research

Thousand Oaks, California, 91360, United States

Location

Upland Clinical Research

Upland, California, 91786, United States

Location

Advanced RX Clinicial Research Group, Inc.

Westminster, California, 92683, United States

Location

Connecticut Clinical Research Foundation

Bristol, Connecticut, 06010, United States

Location

Medical Research Center of Connecticut, LLC

Hamden, Connecticut, 06518, United States

Location

Innovative Research of West Florida, Inc.

Clearwater, Florida, 33756, United States

Location

Digestive Care of N. Broward

Coral Springs, Florida, 33065, United States

Location

Homestead Medical Research

Homestead, Florida, 33030, United States

Location

Clinical Neuroscience Solutions Inc.

Jacksonville, Florida, 32256, United States

Location

Health Awareness, Inc.

Jupiter, Florida, 33458, United States

Location

Precision Clinical Research LLC

Lauderdale Lakes, Florida, 33319, United States

Location

Pharmax Research Clinic Inc.

Miami, Florida, 33126, United States

Location

Well Pharma Medical Research, Corp.

Miami, Florida, 33143, United States

Location

Ocean Blue Medical Research Center, Inc

Miami Springs, Florida, 33166, United States

Location

Bravo Health Care Center

North Bay Village, Florida, 33141, United States

Location

Clinical Neuroscience Solutions Inc.

Orlando, Florida, 32801, United States

Location

Clinical Research of West Florida Inc.

Tampa, Florida, 33603, United States

Location

Meridien Research

Tampa, Florida, 33634, United States

Location

Emory University School of Medicine

Atlanta, Georgia, 30322, United States

Location

RNA America, LLC

Buford, Georgia, 30518, United States

Location

Northwestern University Feinbery School of Medicine

Chicago, Illinois, 606611, United States

Location

Pharmakon Inc

Evergreen Park, Illinois, 60805, United States

Location

Investigators Research

Brownsburg, Indiana, 46112, United States

Location

Radiant Research, Inc.

Evansville, Indiana, 47714, United States

Location

Clinical Research Advantage Inc/Radiant Research Inc.

Evansville, Indiana, 47725, United States

Location

Gtc Research

Shawnee Mission, Kansas, 66218, United States

Location

Investigative Clinical Research

Annapolis, Maryland, 21401, United States

Location

MGG Group Co. Inc. Chevy Chase Clinical Research

Chevy Chase, Maryland, 20815, United States

Location

MedVadis Research Corporation

Watertown, Massachusetts, 02472, United States

Location

Clinical Research Insititute of Michigan LLC

Chesterfield, Michigan, 48047, United States

Location

Gastroenterology Associates of Western Michigan, PLC

Wyoming, Michigan, 49519, United States

Location

The Center for Clinical Trials

Biloxi, Mississippi, 39531, United States

Location

Women's Clinic of Lincoln, P.C.

Lincoln, Nebraska, 68510, United States

Location

Quality Clinical Research Inc.

Omaha, Nebraska, 68114, United States

Location

Advanced Biomedical Research of America

Las Vegas, Nevada, 89123, United States

Location

Advanced Research Institute

Reno, Nevada, 89511, United States

Location

Drug Trials Brooklyn

Brooklyn, New York, 11230, United States

Location

NY Scientific

Brooklyn, New York, 11235, United States

Location

Long Island Gastrointestinal Group LLP

Great Neck, New York, 11023, United States

Location

IMA Medical Research, PC

Kew Gardens, New York, 11415, United States

Location

Charlotte Gastroenterology & Hepatology, PLLC

Charlotte, North Carolina, 28207, United States

Location

Peters Medical Research LLC

High Point, North Carolina, 27265, United States

Location

North State Clincial Research PLLC

Lenoir, North Carolina, 28645, United States

Location

Wake Research Associates LLC

Raleigh, North Carolina, 27612, United States

Location

Trial Management Associates, LLC

Wilmington, North Carolina, 28403, United States

Location

Clinical Inquest Center Ltd

Beavercreek, Ohio, 45431, United States

Location

Hometown Urgent Care and Research

Cincinnati, Ohio, 45215, United States

Location

Buckeye Health and Research

Columbus, Ohio, 43207, United States

Location

Hometown Urgent Care and Research

Columbus, Ohio, 43214, United States

Location

Hometown Urgent Care and Research

Huber Heights, Ohio, 45424, United States

Location

Central Sooner Research

Norman, Oklahoma, 73071, United States

Location

The Oregon Center for Clinical Investigations, INC.

Salem, Oregon, 97301, United States

Location

Partners in Clinical Research

Cumberland, Rhode Island, 02864, United States

Location

WR-ClinSearch, LLC

Chattanooga, Tennessee, 37421, United States

Location

New Phase Research & Development

Knoxville, Tennessee, 37909, United States

Location

CNS Healthcare

Memphis, Tennessee, 38119, United States

Location

Premier Family Physicians

Austin, Texas, 78735, United States

Location

Family Medicine Associate of Texas

Carrollton, Texas, 75010, United States

Location

Multi-Phase Trials LLC

San Antonio, Texas, 78217, United States

Location

Health Texas Research Institute

San Antonio, Texas, 78228, United States

Location

Discovery Clinical Trials - Stone Oak

San Antonio, Texas, 78258, United States

Location

Carl Meisner Medical Clinic

Sugar Land, Texas, 77478, United States

Location

Advanced Research Institute - Ogden

Ogden, Utah, 84405, United States

Location

Wasatch Clinical Research, LLC

Salt Lake City, Utah, 84107, United States

Location

Gastroenterology Associates of Northern Virginia

Fairfax, Virginia, 22031, United States

Location

Blue Ridge Medical Research

Lynchburg, Virginia, 24502, United States

Location

Corunna Medical Research Centre

Corunna, Ontario, N0N 1G0, Canada

Location

Manna Research

Etobicoke, Ontario, 7LM 4Y1, Canada

Location

SKDS Research Inc

Newmarket, Ontario, L3Y 5G8, Canada

Location

University of Calgary

Calgary, T2N 1N4, Canada

Location

Viable Clinical Research Corp.

Nova Scotia, B4V 3N2, Canada

Location

Centre de reserche St Louis

Québec, G1W4R4, Canada

Location

Dynamik Research Inc

Québec, H9R 3J1, Canada

Location

Related Links

• More Information

MeSH Terms

Interventions

eluxadoline

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: Allergan, Inc

IR-CTRegistration@allergan.com

714-246-4500

Study Officials

• Esther Jo

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2016
• First Posted: November 9, 2016
• Study Start: October 25, 2016
• Primary Completion: January 22, 2018
• Study Completion: January 22, 2018
• Last Updated: February 15, 2019
• Results First Posted: February 15, 2019

Record last verified: 2019-01

Locations

US (76); CA (7)