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Irritable Bowel SyndromePhase 2NCT03339128

Study to Explore the Therapeutic Effect of Eluxadoline in Treating Irritable Bowel Syndrome With Diarrhea in Children

A Phase 2 study testing Eluxadoline in people with Irritable Bowel Syndrome, run by AbbVie at 46 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The primary objectives of this study are to explore the therapeutic effect of eluxadoline in treating irritable bowel syndrome with diarrhea (IBS-D) in pediatric participants 6-17 years of age, to evaluate the pharmacokinetics of eluxadoline in pediatric participants with IBS-D, and to evaluate the safety and… Read more about this study

Who is it for?
Ages 6 to 17 years
Conditions the study is for
Irritable Bowel Syndrome
What is being tested?
Eluxadoline
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
272 participants
Where
46 sitesin 9 countries
Study dates
15 Nov 2017to 17 Aug 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Participant must provide written or verbal informed assent and the parent/guardian/LAR must provide written informed consent before the initiation of any study-specific procedures.
  • Participant is a male or female outpatient, 6 to 17 years of age inclusive, at the time the participant provides assent for the study and parent/guardian/LAR has provided signed consent.
  • Participant is able to read and understand the assessments in the eDiary. If the participant is 6 to 11 years of age and does not meet this criterion, the interviewer-administered version of the eDiary must be used and the parent/guardian/LAR or caregiver who will be administering the interviewer-administered version of the eDiary must be able to read and understand the assessments in the eDiary and must undergo training.
  • Female participants must not be pregnant, breastfeeding, or considering becoming pregnant during the study or for approximately 30 days after the last dose of study drug. Female participants of childbearing potential must have a negative serum pregnancy test at Visit 1 (screening) and a negative urine pregnancy test at Visit 3 (randomization) prior to dosing.
  • Female participants of childbearing potential must practice at least 1 protocol-specified method of birth control, that is effective from Study Day 1 through at least 30 days after the last dose of study drug. Local practices may require 2 methods of birth control. Female participants of non-childbearing potential do not need to use birth control.
  • Participant has a diagnosis of IBS-D as defined by the modified Rome IV child/adolescent criteria: Must include all of the following:
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  • -- Abdominal pain at least 4 days per month over at least 2 months associated with one or more of the following:
  • Related to defecation
  • A change in frequency of stool
  • A change in form (appearance) of stool
  • After appropriate evaluation, the symptoms cannot be fully explained by another medical condition.
  • Participant has predominantly diarrheal stool symptoms defined as Bristol stool types 6 or 7 for more than 25% of bowel movements and Bristol stool types 1 or 2 for less than 25% of bowel movements that occur in the absence of laxative.
  • Participant may be newly diagnosed with IBS-D by the investigator at Visit 1. All criteria for diagnosis must be fulfilled for at least 2 months prior to Visit 1 (screening).
  • Participant has been compliant with the eDiary by completing both the morning and evening assessments for at least 8 out of the 14 days immediately preceding Visit 3 (randomization).
  • Participant has an average daytime abdominal pain score greater than or equal to 1.0 over the 2 weeks prior to randomization.
  • Participant has at least 1 daytime bowel movement with a consistency of Type 6 or Type 7 on the pediatric Bristol Stool Form Scale (p-BSFS) on at least 2 days per week during the 2 weeks immediately prior to randomization and that occurs in the absence of laxatives.

Who cannot join

  • Participant has no gallbladder, (ie, agenesis of the gallbladder or cholecystectomy).
  • Participant has had any of the following surgeries:
  • Any abdominal surgery within the 3 months prior to Screening; or
  • A history of major gastric, hepatic, pancreatic, or intestinal surgery. (Note: appendectomy, hemorrhoidectomy, or polypectomy greater than 3 months post-surgery are allowed. For the purposes of this study, laparoscopic surgeries without complication are considered minor and non-exclusionary, provided the condition for which the surgery was performed was not exclusionary.)
  • Participant has a history of chronic or severe constipation or sequelae from constipation, or known or suspected mechanical GI obstruction or pseudo obstruction.
  • Participant has a history or current diagnosis of constipation with encopresis.
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  • Participant meets the child/adolescent Rome IV criteria of IBS with constipation, IBS with constipation and diarrhea (mixed), unspecified IBS, or functional constipation.
  • Participant has a history of intestinal obstruction, stricture, toxic megacolon, GI perforation, fecal impaction, gastric banding, bariatric surgery, adhesions, ischemic colitis, or impaired intestinal circulation.
  • Participant has a documented history of hepatic impairment as defined by Child-Pugh Classification Grade A, B or C.
  • Participant has a history or current diagnosis of inflammatory or immune-mediated lower GI disorders including inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, microscopic colitis). Crohn's disease affecting the upper GI tract would also be exclusionary.
  • Participant has celiac disease, or a positive serological test for celiac disease and the condition has not been ruled out by endoscopic biopsy.
  • Participant has any congenital and/or acquired malabsorption syndrome (eg, Shwachman-Diamond syndrome).
  • Participant has a history of a microbiologically documented (ie, stool culture or medical history) GI infection within 3 months prior to Screening.
  • Participant has a known lactose or fructose intolerance that is associated with diarrhea, abdominal pain or discomfort, and that could confound assessments in the study.
  • Participant has a history of diverticulitis within 3 months prior to Screening.

Trial locations and contacts

46 sites in 9 countries.

46 sites in 9 countries

United States26 sites

  • Global Research Associates /ID# 234646

    Atlanta, Georgia, 30315

  • Children's Ctr Digestive, US /ID# 237575

    Atlanta, Georgia, 30342

  • Kindred Medical Institute, LLC /ID# 237368

    Corona, California, 92879

  • Cook Children's Med. Center /ID# 237537

    Fort Worth, Texas, 76104

  • Duplicate_VVCRD Research /ID# 234606

    Garden Grove, California, 92845

  • HealthStar Research of Hot Springs PLLC /ID# 234609

    Hot Springs, Arkansas, 71913

  • Texas Children's Hospital /ID# 238304

    Houston, Texas, 77030-2608

  • Indiana University Health Riley Hospital for Children /ID# 235400

    Indianapolis, Indiana, 46202

  • Michael W. Simon, MD, PSC /ID# 236517

    Lexington, Kentucky, 40517

  • Applied Research Center of Arkansas /ID# 238070

    Little Rock, Arkansas, 72212-4187

  • Celen Medical Group Corp - Marlton /ID# 234922

    Marlton, New Jersey, 08053

  • Sunrise Research Institute /ID# 237382

    Miami, Florida, 33130

  • South Miami Medical & Research Group Inc. /ID# 234655

    Miami, Florida, 33155

  • Valencia Medical & Research Center /ID# 234672

    Miami, Florida, 33165

  • Florida Research Center, Inc. /ID# 236514

    Miami, Florida, 33174

  • Duplicate_Wellness Clinical Research /ID# 237401

    Miami Lakes, Florida, 33016

  • MNGI Digestive Health, P. A. /ID# 238057

    Minneapolis, Minnesota, 55413-2195

  • West Virginia University Hospitals /ID# 256841

    Morgantown, West Virginia, 26506

  • Frederick County Pediatrics /ID# 234519

    New Market, Maryland, 21774-6154

  • IPS Research Company /ID# 237672

    Oklahoma City, Oklahoma, 73106

  • Duplicate_Center for Clinical Trials LLC /ID# 234630

    Paramount, California, 90723

  • Advocate Children's Hospital-Park Ridge /ID# 235388

    Park Ridge, Illinois, 60068

  • Children's Hospital of Philadelphia - Main /ID# 234313

    Philadelphia, Pennsylvania, 19104-4319

  • Preferred Primary Care Physicians, Inc. /ID# 236436

    Pittsburgh, Pennsylvania, 15236

  • Sun Research Institute /ID# 236933

    San Antonio, Texas, 78215

  • Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 236343

    Stockbridge, Georgia, 30281

Other trials in United States

Poland6 sites

  • Copertnicus Podmiot Leczniczy Sp. z o.o. /ID# 235656

    Gdansk, Pomeranian Voivodeship, 80-803

  • Specjalistyczne Gabinety Sp. z o.o. /ID# 236347

    Krakow, Lesser Poland Voivodeship, 30-539

  • Instytut Centrum Zdrowia Matki Polki /ID# 237438

    Lodz, Łódź Voivodeship, 93-338

  • Korczowski Bartosz Gabinet Lekarski /ID# 234683

    Rzeszów, Podkarpackie Voivodeship, 35-302

  • Centrum Zdrowia MDM /ID# 237269

    Warsaw, Masovian Voivodeship, 00-189

  • Duplicate_Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 234311

    Warsaw, Masovian Voivodeship, 04-730

Other trials in Poland

Bulgaria3 sites

  • MHATSv.Ivan Rilski /ID# 235399

    Kozloduy, 3320

  • University Hospital Plovdiv /ID# 235450

    Plovdiv, 4001

  • Medical center 1 Sevlievo /ID# 237473

    Sevlievo, Gabrovo, 5400

Other trials in Bulgaria

Hungary3 sites

  • Eszak-Kozep-budai Centrum, Uj Szent Janos Korhaz /ID# 236993

    Budapest, 1125

  • Soproni Erzsebet Oktato Korhaz es Rehabilitacios Intezet /ID# 237341

    Sopron, 9400

  • Vita Verum Medical Bt. /ID# 234321

    Székesfehérvár, 8000

Other trials in Hungary

United Kingdom3 sites

  • Blackpool Teaching Hospitals NHS Foundation Trust /ID# 237273

    Blackpool, FY3 8NR

  • Kings College Hospital NHS Foundation Trust /ID# 236305

    London, Greater London, SE5 9RS

  • Duplicate_Manchester University NHS Foundation Trust /ID# 234663

    Manchester, Lancashire, M13 9WL

Other trials in United Kingdom

Canada2 sites

  • Duplicate_Edmonton Clinic Health Academy (ECHA) /ID# 234917

    Edmonton, T6G 1C9

  • Manitoba Institute of Child Health /ID# 235448

    Winnepeg, R3E 3P4

Other trials in Canada

Germany1 site

  • HELIOS Klinikum Wuppertal /ID# 237322

    Wuppertal, 42283

Other trials in Germany

Netherlands1 site

  • Duplicate_Academisch Medisch Centrum /ID# 237117

    Amsterdam, North Holland, 1105 AZ

Other trials in Netherlands

Spain1 site

  • Hospital Universitario Dr. Peset /ID# 236755

    Valencia, 46017

Other trials in Spain

About this study

Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Evaluate the Safety and Efficacy of Eluxadoline in Pediatric Participants (Age 6 to 17 Years) With Irritable Bowel Syndrome With Diarrhea (IBS-D)

The primary objectives of this study are to explore the therapeutic effect of eluxadoline in treating irritable bowel syndrome with diarrhea (IBS-D) in pediatric participants 6-17 years of age, to evaluate the pharmacokinetics of eluxadoline in pediatric participants with IBS-D, and to evaluate the safety and tolerability of eluxadoline in pediatric participants with IBS-D. Enrollment of 12-17 years old age group is closed, enrollment of the 6-11 years old age group will continue.

Being tested
Eluxadoline, Placebo
Keywords
Irritable Bowel Syndrome with Diarrhea, IBS, IBSD, IBS-D, Irritable Bowel Syndrome, Pediatric
Medical subject headings
Irritable Bowel Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EluxadolineDrug

    Also called Viberzi

    Oral tablets

  • PlaceboDrug

    Oral tablets

Study groups in NCT03339128
Study groupRoleWhat they receive
Eluxadoline 25mgExperimentalEluxadoline 25mg, oral administration, twice daily
Receives: Drug: Eluxadoline
Eluxadoline 50mgExperimentalEluxadoline 50mg, oral administration, twice daily
Receives: Drug: Eluxadoline
Eluxadoline 100mgExperimentalEluxadoline 100mg, oral administration, twice daily
Receives: Drug: Eluxadoline
PlaceboExperimentalDose-matched placebo, oral administration, twice daily
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in stool consistency averaged over the 4-week Treatment Period

    Stool consistency will be assessed using the Pediatric Bristol Stool Form Scale (p-BSFS) on a range from 1 (Hard Lumps) to 7 (Watery).

    Measured: Baseline (2 Weeks prior to randomization) to Week 4

Secondary outcomes (5)

  1. Change from baseline in stool consistency for daily daytime and nighttime stool consistency scores

    Stool consistency will be assessed using the Pediatric Bristol Stool Form Scale (p-BSFS) on a range from 1 (Hard Lumps) to 7 (Watery).

    Measured: Baseline (2 Weeks prior to randomization) to Week 4

  2. Change from baseline for daytime, nighttime, and 24-hour abdominal pain scores

    Abdominal Pain is scored on a five-point ordinal scale, with 0 meaning no pain, and 4 meaning a lot of pain.

    Measured: Baseline (2 Weeks prior to randomization) to Week 4

  3. Change from baseline for daytime, nighttime, and 24-hour bowel movement frequency

    Change from baseline in the number of bowel movements.

    Measured: Baseline (2 Weeks prior to randomization) to Week 4

  4. Change from baseline for daytime, nighttime, and 24 hour urgency-free days

    Change from baseline in the number of urgency free days in a week.

    Measured: Baseline (2 Weeks prior to randomization) to Week 4

  5. Change from baseline for daytime, nighttime, and 24 hour number of fecal incontinence-free days

    Change from baseline in the number of fecal incontinence-free days in a week.

    Measured: Baseline (2 Weeks prior to randomization) to Week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2017
  2. Study start15 Nov 2017
  3. Primary completion17 Aug 2026
  4. Study completion17 Aug 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
272 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03339128
Sponsor's protocol ID
3030-202-002
Other IDs
2017-003770-14, 2017
Status last verified
Sep 2026
First submitted
8 Nov 2017
Last updated
21 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Eluxadoline in people with Irritable Bowel Syndrome, run by AbbVie at 46 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 46 sites in United States, Poland, Bulgaria, Hungary, United Kingdom and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in stool consistency averaged over the 4-week Treatment Period (time frame: Baseline (2 Weeks prior to randomization) to Week 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03339128.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.

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