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Eluxadoline for Irritable Bowel Syndrome
Study Summary
This trial is testing whether eluxadoline is an effective and safe treatment for IBS-D in children 6-17 years old.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 4 trial • 24 Patients • NCT03441581Trial Design
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- I haven't had major abdominal surgery in the last 3 months.I have had diverticulitis in the last 3 months.I am between 6 and 17 years old and have my guardian's consent to participate.I am a woman who can have children and have had negative pregnancy tests.I am using reliable birth control methods if I am sexually active.I mostly have watery or mushy bowel movements without using laxatives.I have celiac disease or a positive test for it without a biopsy ruling it out.I have a condition that affects my body's ability to absorb nutrients.I have lactose or fructose intolerance that causes diarrhea or abdominal pain.I do not have a gallbladder.I have or had constipation with accidental bowel leakage.I have or had an inflammatory or immune-related lower GI disorder, including Crohn's in the upper GI.I have been diagnosed with a type of IBS or functional constipation according to Rome IV criteria.My stool looks different than it used to.I have been diagnosed with IBS-D, experiencing abdominal pain and changes in my bowel movements.I had a confirmed GI infection in the last 3 months.My bowel movements have changed in frequency.I have a liver condition classified as mild, moderate, or severe.I have a history of severe constipation or related complications.I have had serious intestinal problems or surgeries.My average stomach pain has been mild or none in the last 2 weeks.My bowel movements are normal.My symptoms are not caused by another known medical condition.You must use two forms of birth control at the same time, such as a condom and an intrauterine device or a diaphragm and spermicide.I have had loose stools without using laxatives at least twice a week in the last 2 weeks.
- Group 1: Eluxadoline 50mg
- Group 2: Eluxadoline 100mg
- Group 3: Placebo
- Group 4: Eluxadoline 25mg
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Does the age criterion for entry into this trial cap at 25 years old?
"This research trial is currently searching for participants aged between 6 to 17 years."
Are there any currently open enrollment slots for this experiment?
"The information on clinicaltrials.gov reveals that this medical trial is currently recruiting participants. This experiment was initially published on November 15th 2017 and most recently amended on October 31st 2022."
What other experiments have been conducted to assess the impact of Eluxadoline?
"The first trial of eluxadoline took place in 2017 at the UH Rainbow Babies & Children's Hospital, with 18,322 trials that have since been completed. At present, 3 clinical investigations are ongoing within Silver Spring, Maryland."
Do I fulfill the criteria for participation in this medical experiment?
"The current trial is searching for 120 participants aged 6 to 17 who suffer from irritable bowel syndrome and meet the following criteria: a change in frequency or form of stool; inflammation that cannot be attributed to another medical issue; usage of double-barrier contraceptives (eg, diaphragm plus spermicide); literate enough to read their assessments if self-administering or have an adult present with them capable of reading and understanding such assessments."
What is the size of the cohort that is participating in this trial?
"Indeed, clinicaltrials.gov indicates that this medical trial is currently enrolling patients; it was created on the 15th of November 2017 and last updated at the end of October 2022. The researchers aim to recruit 120 participants across 48 centres."
Has the United States Food and Drug Administration authorized the use of Eluxadoline?
"Because Eluxadoline is still in the second phase of clinical trials, there are indications that it can be safely used but no verifiable evidence of its efficacy. Thus, our team at Power has assigned a rating of 2 to this drug's safety profile."
To what extent has this experiment been conducted in various locations?
"This medical trial is currently running in 48 distinct sites, situated across the country - including Silver Spring, Fort Worth and Pittsburgh. To reduce any inconvenience or travel burden as a participant, it's best to ensure you select a site nearest your locale."
Is this a pioneering research effort?
"Currently, 3 different studies of eluxadoline are being conducted across 50 cities and 12 countries. Funded by Allergan, the first clinical trial for this drug began back in 2017 with 120 participants and successfully completed Phase 2 approval. Since then, over 18 thousand additional experiments have been undertaken."
Who else is applying?
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