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New treatment option for Irritable Bowel Syndrome
Official title Study to Explore the Therapeutic Effect of Eluxadoline in Treating Irritable Bowel Syndrome With Diarrhea in Children
ClinicalTrials.gov ID: NCT03339128
What this study is testing
What is Eluxadoline?
Eluxadoline is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for irritable bowel syndrome.
Also referred to as Viberzi.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 17
You may be able to join if
- Participant must provide written or verbal informed assent and the parent/guardian/LAR must provide written informed consent before the initiation of...
- 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...
- 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...
- Female participants must not be pregnant, breastfeeding, or considering becoming pregnant during the study or for approximately 30 days after the...
- Female participants of childbearing potential must practice at least 1 protocol-specified method of birth control, that is effective from Study Day 1...
You likely can't join if
- 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...
- Participant has a history of chronic or severe constipation or sequelae from constipation, or known or suspected mechanical GI obstruction or pseudo...
- Participant has a history or current diagnosis of constipation with encopresis.
See the full eligibility criteria
Who can 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...
- 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...
- 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...
- Participant has a diagnosis of IBS-D as defined by the modified Rome IV child/adolescent criteria: Must include all of the following: \-- Abdominal pain at least 4 days per month over at least 2 months associated with...
- 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...
- 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...
What rules you out
- 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...
- 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Hot Springs, Arkansas, United States
- Little Rock, Arkansas, United States
- Corona, California, United States
- Garden Grove, California, United States
- Paramount, California, United States
- Miami, Florida, United States
- Miami Lakes, Florida, United States
- Atlanta, Georgia, United States
- Stockbridge, Georgia, United States
- Park Ridge, Illinois, United States
- Indianapolis, Indiana, United States
- Lexington, Kentucky, United States
- New Market, Maryland, United States
- Minneapolis, Minnesota, United States
- Marlton, New Jersey, United States
- Oklahoma City, Oklahoma, United States
- Philadelphia, Pennsylvania, United States
- Pittsburgh, Pennsylvania, United States
- Fort Worth, Texas, United States
- Houston, Texas, United States
+ 21 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hot Springs, Arkansas, United States; Little Rock, Arkansas, United States; Corona, California, United States; Garden Grove, California, United States; Paramount, California, United States; Miami, Florida, United States and 35 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.