Irritable Bowel SyndromePhase 3NCT04880876
A Study Evaluating Oral Eluxadoline Administered to Pediatric Participants With Irritable Bowel Syndrome With Diarrhea (IBS-D)
A Phase 3 study testing 25mg Eluxadoline and 100mg Eluxadoline in people with Irritable Bowel Syndrome, run by AbbVie at 6 sites in United States.
Trial summary
This study will assess the long-term safety of oral Eluxadoline administered to pediatric participants with IBS-D who have completed study intervention in the Phase 2 study 3030-202-002 or the Phase 3 study 3030-303-002. 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?
- 25mg Eluxadoline and 100mg Eluxadoline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 6 sitesUnited States
- Study dates
- 13 Aug 2021to Dec 2032
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Male or female participants must be 6 to 17 years of age (inclusive)
- Participants must have completed study intervention in their lead-in study
Who cannot join
- Participant has an unresolved AE or a clinically significant finding on a physical examination, vital sign assessment, or neurological assessment along with an ECG or clinical laboratory tests (if results are available by the time of enrollment) that; in the opinion of the investigator, could represent a safety concern or a condition that would be exclusionary, could prevent the participant from performing any protocol assessments, or could confound study assessments.
- Participant has known allergies or hypersensitivity to opioids
- Female participants who are currently pregnant or nursing, or plan to become pregnant or nurse during the clinical study.
- Participant has no gallbladder, (ie, agenesis of the gallbladder or cholecystectomy).
- Participant has known or suspected biliary duct obstruction, or sphincter of Oddi disease or dysfunction
- Participant has a history of pancreatitis; structural diseases of the pancreas, known or suspected pancreatic duct obstruction
Show all 9Show fewer
- 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 renal impairment or an unstable hepatic, metabolic, or hematologic condition.
- Participant is a current regular alcohol drinker and/or binge drinker*, and/or has a history of alcoholism, alcohol abuse (eg, binge-drinking*), or alcohol addiction, and/or intends to consume alcohol during the study
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites
Kindred Medical Institute, LLC /ID# 227595
Corona, California, 92879
Valencia Medical & Research Center /ID# 246221
Miami, Florida, 33165
Florida Research Center, Inc. /ID# 227597
Miami, Florida, 33174
IPS Research Company /ID# 227594
Oklahoma City, Oklahoma, 73106
Preferred Primary Care Physicians, Inc. /ID# 227596
Pittsburgh, Pennsylvania, 15236
Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 227600
Stockbridge, Georgia, 30281
About this study
Official title: A Phase 3, Long-term Safety Study of Oral Eluxadoline Administered to Pediatric Participants With Irritable Bowel Syndrome With Diarrhea (IBS-D)
This study will assess the long-term safety of oral Eluxadoline administered to pediatric participants with IBS-D who have completed study intervention in the Phase 2 study 3030-202-002 or the Phase 3 study 3030-303-002.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- 25mg Eluxadoline, 100mg Eluxadoline
- Keywords
- Irritable Bowel Syndrome with Diarrhea 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.
25mg EluxadolineDrug
Oral Tablets
100mg EluxadolineDrug
Oral Tablets
| Study group | Role | What they receive |
|---|---|---|
| Open Label 6-11 years of age: Eluxadoline 50mg | Experimental | Eluxadoline two 25mg tablets, oral administration, twice daily with food. Take at approximately the same time each day. Receives: Drug: 25mg Eluxadoline |
| Open Label 12-17 years of age: Eluxadoline 100 mg | Experimental | Eluxadoline one 100mg tablet, oral administration, twice daily with food. May use 25mg tablets to administer 100mg dose. Take at approximately the same time each day. Receives: Drug: 25mg Eluxadoline; Drug: 100mg Eluxadoline |
| Double Blind 6-11 years of age: Eluxadoline 25mg | Experimental | Blinding will be accomplished via administration of a constant number of oral tablets in each age group (6 to 11 years of age and 12 to 17 years of age) where all participants in an age group will receive the same total number of oral tablets at each administration. Phase 2 completers who choose to remain on double-blind eluxadoline and received placebo in the lead-in Phase 2 study 3030-202-002 will be assigned to double-blind eluxadoline 25 mg BID Receives: Drug: 25mg Eluxadoline |
| Double Blind 6-11 years of age: Eluxadoline 50mg | Experimental | Blinding will be accomplished via administration of a constant number of oral tablets in each age group (6 to 11 years of age and 12 to 17 years of age) where all participants in an age group will receive the same total number of oral tablets at each administration. Phase 2 completers who choose to remain on double-blind eluxadoline and received placebo in the lead-in Phase 2 study 3030-202-002 will be assigned to double-blind eluxadoline 25 mg BID Receives: Drug: 25mg Eluxadoline |
| Double Blind 12-17 years of age: Eluxadoline 25mg | Experimental | Blinding will be accomplished via administration of a constant number of oral tablets in each age group (6 to 11 years of age and 12 to 17 years of age) where all participants in an age group will receive the same total number of oral tablets at each administration. Phase 2 completers who choose to remain on double-blind eluxadoline and received placebo in the lead-in Phase 2 study 3030-202-002 will be assigned to double-blind eluxadoline 25 mg BID Receives: Drug: 25mg Eluxadoline |
| Double Blind 12-17 years of age: Eluxadoline 50mg | Experimental | Blinding will be accomplished via administration of a constant number of oral tablets in each age group (6 to 11 years of age and 12 to 17 years of age) where all participants in an age group will receive the same total number of oral tablets at each administration. Phase 2 completers who choose to remain on double-blind eluxadoline and received placebo in the lead-in Phase 2 study 3030-202-002 will be assigned to double-blind eluxadoline 25 mg BID Receives: Drug: 25mg Eluxadoline |
| Double Blind 12-17 years of age: Eluxadoline 100mg | Experimental | Blinding will be accomplished via administration of a constant number of oral tablets in each age group (6 to 11 years of age and 12 to 17 years of age) where all participants in an age group will receive the same total number of oral tablets at each administration. Phase 2 completers who choose to remain on double-blind eluxadoline and received placebo in the lead-in Phase 2 study 3030-202-002 will be assigned to double-blind eluxadoline 25 mg BID Receives: Drug: 25mg Eluxadoline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with Adverse Events
Measured: 52 weeks
Percentage of Participants with Clinically Significant Laboratory Values (clinical chemistry, complete blood count, urinalysis) as assessed by the Investigator
Measured: 52 weeks
Percentage of Participants with Clinically Significant ECGs as assessed by the Investigator
Measured: 52 weeks
Percentage of Participants with Clinically Significant vital sign measurements as assessed by the Investigator
Measured: 52 weeks
Percentage of Participants with any new Physical examination abnormality or worsening of change from baseline
Measured: 52 weeks
Percentage of Participants with any new neurological abnormality post baseline or worsening of change from baseline
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2021
- Study start13 Aug 2021
- Primary completionDec 2032 (estimated)
- Study completionDec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04880876
- Sponsor's protocol ID
- 3030-302-002
- Status last verified
- Jul 2025
- First submitted
- 16 Apr 2021
- Last updated
- 17 Jul 2025
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Long-term Safety Study of Oral Eluxadoline Administered to Pediatric Participants With Irritable Bowel Syndrome With Diarrhea (IBS-D)
- ClinicalTrials.gov ID
- NCT04880876
- Acronym / sponsor ID
- 3030-302-002
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Irritable Bowel Syndrome with Diarrhea IBSD IBS-D Irritable Bowel Syndrome Pediatric
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 13 Aug 2021 (actual)
- Primary completion
- Dec 2032 (estimated)
- Study completion
- Dec 2032 (estimated)
- First posted
- 11 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the long-term safety of oral Eluxadoline administered to pediatric participants with IBS-D who have completed study intervention in the Phase 2 study 3030-202-002 or the Phase 3 study 3030-303-002.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Open Label 6-11 years of age: Eluxadoline 50mg | Experimental | Drug: 25mg EluxadolineEluxadoline two 25mg tablets, oral administration, twice daily with food. Take at approximately the same time each day. |
| Open Label 12-17 years of age: Eluxadoline 100 mg | Experimental | Drug: 25mg Eluxadoline, Drug: 100mg EluxadolineEluxadoline one 100mg tablet, oral administration, twice daily with food. May use 25mg tablets to administer 100mg dose. Take at approximately the same time each day. |
| Double Blind 6-11 years of age: Eluxadoline 25mg | Experimental | Drug: 25mg EluxadolineBlinding will be accomplished via administration of a constant number of oral tablets in each age group (6 to 11 years of age and 12 to 17 years of age) where all participants in an age group will receive the same total number of oral tablets at each administration. Phase 2 completers who choose to remain on double-blind eluxadoline and received placebo in the lead-in Phase 2 study 3030-202-002 will be assigned to double-blind eluxadoline 25 mg BID |
| Double Blind 6-11 years of age: Eluxadoline 50mg | Experimental | Drug: 25mg EluxadolineBlinding will be accomplished via administration of a constant number of oral tablets in each age group (6 to 11 years of age and 12 to 17 years of age) where all participants in an age group will receive the same total number of oral tablets at each administration. Phase 2 completers who choose to remain on double-blind eluxadoline and received placebo in the lead-in Phase 2 study 3030-202-002 will be assigned to double-blind eluxadoline 25 mg BID |
| Double Blind 12-17 years of age: Eluxadoline 25mg | Experimental | Drug: 25mg EluxadolineBlinding will be accomplished via administration of a constant number of oral tablets in each age group (6 to 11 years of age and 12 to 17 years of age) where all participants in an age group will receive the same total number of oral tablets at each administration. Phase 2 completers who choose to remain on double-blind eluxadoline and received placebo in the lead-in Phase 2 study 3030-202-002 will be assigned to double-blind eluxadoline 25 mg BID |
| Double Blind 12-17 years of age: Eluxadoline 50mg | Experimental | Drug: 25mg EluxadolineBlinding will be accomplished via administration of a constant number of oral tablets in each age group (6 to 11 years of age and 12 to 17 years of age) where all participants in an age group will receive the same total number of oral tablets at each administration. Phase 2 completers who choose to remain on double-blind eluxadoline and received placebo in the lead-in Phase 2 study 3030-202-002 will be assigned to double-blind eluxadoline 25 mg BID |
| Double Blind 12-17 years of age: Eluxadoline 100mg | Experimental | Drug: 25mg EluxadolineBlinding will be accomplished via administration of a constant number of oral tablets in each age group (6 to 11 years of age and 12 to 17 years of age) where all participants in an age group will receive the same total number of oral tablets at each administration. Phase 2 completers who choose to remain on double-blind eluxadoline and received placebo in the lead-in Phase 2 study 3030-202-002 will be assigned to double-blind eluxadoline 25 mg BID |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Male or female participants must be 6 to 17 years of age (inclusive)
- Participants must have completed study intervention in their lead-in study
Key exclusion criteria (9 listed)
- Participant has an unresolved AE or a clinically significant finding on a physical examination, vital sign assessment, or neurological assessment along with an ECG or clinical laboratory tests (if results are available by the time of enrollment) that; in the opinion of the investigator, could represent a safety concern or a condition that would be exclusionary, could prevent the participant from performing any protocol assessments, or could confound study assessments.
- Participant has known allergies or hypersensitivity to opioids
- Female participants who are currently pregnant or nursing, or plan to become pregnant or nurse during the clinical study.
- Participant has no gallbladder, (ie, agenesis of the gallbladder or cholecystectomy).
- Participant has known or suspected biliary duct obstruction, or sphincter of Oddi disease or dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 25mg EluxadolineOral Tablets | Drug | Double Blind 12-17 years of age: Eluxadoline 100mg, Double Blind 12-17 years of age: Eluxadoline 25mg, Double Blind 12-17 years of age: Eluxadoline 50mg, Double Blind 6-11 years of age: Eluxadoline 25mg, Double Blind 6-11 years of age: Eluxadoline 50mg, Open Label 12-17 years of age: Eluxadoline 100 mg, Open Label 6-11 years of age: Eluxadoline 50mg |
| 100mg EluxadolineOral Tablets | Drug | Open Label 12-17 years of age: Eluxadoline 100 mg |
Primary outcome
Percentage of Participants with Adverse Events
Time frame: 52 weeks
Percentage of Participants with Clinically Significant Laboratory Values (clinical chemistry, complete blood count, urinalysis) as assessed by the Investigator
Time frame: 52 weeks
Percentage of Participants with Clinically Significant ECGs as assessed by the Investigator
Time frame: 52 weeks
Percentage of Participants with Clinically Significant vital sign measurements as assessed by the Investigator
Time frame: 52 weeks
Percentage of Participants with any new Physical examination abnormality or worsening of change from baseline
Time frame: 52 weeks
Percentage of Participants with any new neurological abnormality post baseline or worsening of change from baseline
Time frame: 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
ABBVIE INC. study director
AbbVie
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 25mg Eluxadoline and 100mg Eluxadoline in people with Irritable Bowel Syndrome, run by AbbVie at 6 sites in United States.
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 2 inclusion and 9 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: enrolling by invitation, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Percentage of Participants with Adverse Events (time frame: 52 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jul 2025.