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

Primary Purpose

Irritable Bowel Syndrome

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Eluxadoline
Placebo
Sponsored by
Allergan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Irritable Bowel Syndrome with Diarrhea, IBSD, IBS-D, Irritable Bowel Syndrome, Pediatric

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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 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 who have had their first menstrual period and are sexually active must agree to use a reliable form of contraception. Reliable contraception is defined as:

    • Hormonal contraception (eg, oral contraceptive, contraceptive implant, or injectable hormonal contraceptive).
    • Double-barrier method (eg, condom plus intrauterine device, diaphragm plus spermicide).
  • 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 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.
    • All criteria 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 scoreless than or equal to 2.0 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 prior to randomization that occurs in the absence of laxatives.
  • Participant has no clinically significant findings on a physical examination, vital sign assessment, electrocardiogram (ECG), and clinical laboratory tests (clinical chemistry panel, liver biochemical tests, complete blood count, urine drug screen, urinalysis) after providing informed assent and after written consent is obtained, but before receiving the first dose of study treatment. (A central laboratory will be used to evaluate all urine [except urine pregnancy tests] and blood samples and will utilize reference ranges specific to a patient's age and gender. ECGs will be performed and electronically transmitted to a central ECG laboratory for analysis by a pediatric cardiologist in accordance with the instructions provided by the central ECG laboratory. The Investigator will determine if a particular finding is clinically significant. [In making this determination, the Investigator will consider whether the particular finding could represent a condition that would exclude the participant from the study, could represent a safety concern if the participant participates in the study, or could confound the study-specific assessments of safety or efficacy.])

Exclusion Criteria:

  • 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.
  • 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.

Sites / Locations

  • HealthStar Research of Hot Springs PLLC /ID# 234609Recruiting
  • Applied Research Center of Arkansas /ID# 238070Recruiting
  • Kindred Medical Institute, LLC /ID# 237368Recruiting
  • VVCRD Research /ID# 234606
  • Center for Clinical Trials LLC /ID# 234630
  • Wellness Clinical Research /ID# 237401
  • Sunrise Research Institute /ID# 237382
  • South Miami Medical & Research Group Inc. /ID# 234655Recruiting
  • Valencia Medical & Research Center /ID# 234672Recruiting
  • Florida Research Center, Inc. /ID# 236514Recruiting
  • Global Research Associates /ID# 234646Recruiting
  • Children's Ctr Digestive, US /ID# 237575
  • Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 236343Recruiting
  • Advocate Children's Hospital-Park Ridge /ID# 235388
  • Riley Hospital for Children at Indiana University Health /ID# 235400Recruiting
  • Michael W. Simon, MD, PSC /ID# 236517
  • Virgo Carter Pediatrics /ID# 234519Recruiting
  • MNGI Digestive Health, P. A. /ID# 238057
  • Celen Medical Group Corp /ID# 234922
  • IPS Research Company /ID# 237672
  • Children's Hospital of Philadelphia - Main /ID# 234313
  • Preferred Primary Care Physicians, Inc. /ID# 236436Recruiting
  • Cook Children's Med. Center /ID# 237537
  • Texas Children's Hospital /ID# 238304Recruiting
  • Sun Research Institute /ID# 236933
  • MHATSv.Ivan Rilski /ID# 235399
  • University Hospital Plovdiv /ID# 235450
  • Medical center 1 Sevlievo /ID# 237473
  • Edmonton Clinic Health Academy (ECHA) /ID# 234917
  • Eszak-Kozep-budai Centrum, Uj Szent Janos Korhaz /ID# 236993
  • Soproni Erzsebet Oktato Korhaz es Rehabilitacios Intezet /ID# 237341
  • Vita Verum Medical Bt. /ID# 234321
  • Academisch Medisch Centrum /ID# 237117
  • Instytut Centrum Zdrowia Matki Polki /ID# 237438
  • Specjalistyczne Gabinety Sp. z o.o. /ID# 236347
  • Centrum Zdrowia MDM /ID# 237269
  • Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 234311
  • Copertnicus Podmiot Leczniczy Sp. z o.o. /ID# 235656
  • Korczowski Bartosz Gabinet Lekarski /ID# 234683
  • Manchester University NHS Foundation Trust /ID# 234663
  • Blackpool Teaching Hospitals NHS Foundation Trust /ID# 237273
  • King's College Hospital NHS Foundation Trust /ID# 236305

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Eluxadoline 25mg

Eluxadoline 50mg

Eluxadoline 100mg

Placebo

Arm Description

Eluxadoline 25mg, oral administration, twice daily

Eluxadoline 50mg, oral administration, twice daily

Eluxadoline 100mg, oral administration, twice daily

Dose-matched placebo, oral administration, twice daily

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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.
Change from baseline for daytime, nighttime, and 24-hour bowel movement frequency
Change from baseline in the number of bowel movements.
Change from baseline for daytime, nighttime, and 24 hour urgency-free days
Change from baseline in the number urgency free days in a week.
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.

Full Information

First Posted
November 8, 2017
Last Updated
September 25, 2023
Sponsor
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT03339128
Brief Title
Study to Explore the Therapeutic Effect of Eluxadoline in Treating Irritable Bowel Syndrome With Diarrhea in Children
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2017 (Actual)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
December 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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 tolerability of eluxadoline in pediatric participants with IBS-D.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
Irritable Bowel Syndrome with Diarrhea, IBSD, IBS-D, Irritable Bowel Syndrome, Pediatric

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Eluxadoline 25mg
Arm Type
Experimental
Arm Description
Eluxadoline 25mg, oral administration, twice daily
Arm Title
Eluxadoline 50mg
Arm Type
Experimental
Arm Description
Eluxadoline 50mg, oral administration, twice daily
Arm Title
Eluxadoline 100mg
Arm Type
Experimental
Arm Description
Eluxadoline 100mg, oral administration, twice daily
Arm Title
Placebo
Arm Type
Experimental
Arm Description
Dose-matched placebo, oral administration, twice daily
Intervention Type
Drug
Intervention Name(s)
Eluxadoline
Other Intervention Name(s)
Viberzi, Truberzi
Intervention Description
Oral tablets
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral tablets
Primary Outcome Measure Information:
Title
Change from baseline in stool consistency averaged over the 4-week Treatment Period
Description
Stool consistency will be assessed using the Pediatric Bristol Stool Form Scale (p-BSFS) on a range from 1 (Hard Lumps) to 7 (Watery).
Time Frame
Baseline (2 Weeks prior to randomization) to Week 4
Secondary Outcome Measure Information:
Title
Change from baseline in stool consistency for daily daytime and nighttime stool consistency scores
Description
Stool consistency will be assessed using the Pediatric Bristol Stool Form Scale (p-BSFS) on a range from 1 (Hard Lumps) to 7 (Watery).
Time Frame
Baseline (2 Weeks prior to randomization) to Week 4
Title
Change from baseline for daytime, nighttime, and 24-hour abdominal pain scores
Description
Abdominal Pain is scored on a five-point ordinal scale, with 0 meaning no pain, and 4 meaning a lot of pain.
Time Frame
Baseline (2 Weeks prior to randomization) to Week 4
Title
Change from baseline for daytime, nighttime, and 24-hour bowel movement frequency
Description
Change from baseline in the number of bowel movements.
Time Frame
Baseline (2 Weeks prior to randomization) to Week 4
Title
Change from baseline for daytime, nighttime, and 24 hour urgency-free days
Description
Change from baseline in the number urgency free days in a week.
Time Frame
Baseline (2 Weeks prior to randomization) to Week 4
Title
Change from baseline for daytime, nighttime, and 24 hour number of fecal incontinence-free days
Description
Change from baseline in the number of fecal incontinence-free days in a week.
Time Frame
Baseline (2 Weeks prior to randomization) to Week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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 who have had their first menstrual period and are sexually active must agree to use a reliable form of contraception. Reliable contraception is defined as: Hormonal contraception (eg, oral contraceptive, contraceptive implant, or injectable hormonal contraceptive). Double-barrier method (eg, condom plus intrauterine device, diaphragm plus spermicide). 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 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. All criteria 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 scoreless than or equal to 2.0 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 prior to randomization that occurs in the absence of laxatives. Participant has no clinically significant findings on a physical examination, vital sign assessment, electrocardiogram (ECG), and clinical laboratory tests (clinical chemistry panel, liver biochemical tests, complete blood count, urine drug screen, urinalysis) after providing informed assent and after written consent is obtained, but before receiving the first dose of study treatment. (A central laboratory will be used to evaluate all urine [except urine pregnancy tests] and blood samples and will utilize reference ranges specific to a patient's age and gender. ECGs will be performed and electronically transmitted to a central ECG laboratory for analysis by a pediatric cardiologist in accordance with the instructions provided by the central ECG laboratory. The Investigator will determine if a particular finding is clinically significant. [In making this determination, the Investigator will consider whether the particular finding could represent a condition that would exclude the participant from the study, could represent a safety concern if the participant participates in the study, or could confound the study-specific assessments of safety or efficacy.]) Exclusion Criteria: 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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ABBVIE CALL CENTER
Phone
844-663-3742
Email
abbvieclinicaltrials@abbvie.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ALLERGAN INC.
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
HealthStar Research of Hot Springs PLLC /ID# 234609
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Individual Site Status
Recruiting
Facility Name
Applied Research Center of Arkansas /ID# 238070
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72212-4187
Country
United States
Individual Site Status
Recruiting
Facility Name
Kindred Medical Institute, LLC /ID# 237368
City
Corona
State/Province
California
ZIP/Postal Code
92879
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
VVCRD Research /ID# 234606
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Individual Site Status
Completed
Facility Name
Center for Clinical Trials LLC /ID# 234630
City
Paramount
State/Province
California
ZIP/Postal Code
90723
Country
United States
Individual Site Status
Completed
Facility Name
Wellness Clinical Research /ID# 237401
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Individual Site Status
Completed
Facility Name
Sunrise Research Institute /ID# 237382
City
Miami
State/Province
Florida
ZIP/Postal Code
33130
Country
United States
Individual Site Status
Completed
Facility Name
South Miami Medical & Research Group Inc. /ID# 234655
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
Valencia Medical & Research Center /ID# 234672
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
Florida Research Center, Inc. /ID# 236514
City
Miami
State/Province
Florida
ZIP/Postal Code
33174
Country
United States
Individual Site Status
Recruiting
Facility Name
Global Research Associates /ID# 234646
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30315
Country
United States
Individual Site Status
Recruiting
Facility Name
Children's Ctr Digestive, US /ID# 237575
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Individual Site Status
Completed
Facility Name
Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 236343
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Individual Site Status
Recruiting
Facility Name
Advocate Children's Hospital-Park Ridge /ID# 235388
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Individual Site Status
Completed
Facility Name
Riley Hospital for Children at Indiana University Health /ID# 235400
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Name
Michael W. Simon, MD, PSC /ID# 236517
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40517
Country
United States
Individual Site Status
Completed
Facility Name
Virgo Carter Pediatrics /ID# 234519
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
20910
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
MNGI Digestive Health, P. A. /ID# 238057
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55413-2195
Country
United States
Individual Site Status
Completed
Facility Name
Celen Medical Group Corp /ID# 234922
City
Marlton
State/Province
New Jersey
ZIP/Postal Code
08053
Country
United States
Individual Site Status
Completed
Facility Name
IPS Research Company /ID# 237672
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73106
Country
United States
Individual Site Status
Completed
Facility Name
Children's Hospital of Philadelphia - Main /ID# 234313
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4319
Country
United States
Individual Site Status
Completed
Facility Name
Preferred Primary Care Physicians, Inc. /ID# 236436
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15236
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
Cook Children's Med. Center /ID# 237537
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Individual Site Status
Completed
Facility Name
Texas Children's Hospital /ID# 238304
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-2608
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
Sun Research Institute /ID# 236933
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Individual Site Status
Completed
Facility Name
MHATSv.Ivan Rilski /ID# 235399
City
Kozloduy
ZIP/Postal Code
3320
Country
Bulgaria
Individual Site Status
Completed
Facility Name
University Hospital Plovdiv /ID# 235450
City
Plovdiv
ZIP/Postal Code
4001
Country
Bulgaria
Individual Site Status
Completed
Facility Name
Medical center 1 Sevlievo /ID# 237473
City
Sevlievo
ZIP/Postal Code
5400
Country
Bulgaria
Individual Site Status
Completed
Facility Name
Edmonton Clinic Health Academy (ECHA) /ID# 234917
City
Edmonton
ZIP/Postal Code
T6G 1C9
Country
Canada
Individual Site Status
Completed
Facility Name
Eszak-Kozep-budai Centrum, Uj Szent Janos Korhaz /ID# 236993
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
Individual Site Status
Completed
Facility Name
Soproni Erzsebet Oktato Korhaz es Rehabilitacios Intezet /ID# 237341
City
Sopron
ZIP/Postal Code
9400
Country
Hungary
Individual Site Status
Completed
Facility Name
Vita Verum Medical Bt. /ID# 234321
City
Szekesfehervar
ZIP/Postal Code
8000
Country
Hungary
Individual Site Status
Completed
Facility Name
Academisch Medisch Centrum /ID# 237117
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Individual Site Status
Completed
Facility Name
Instytut Centrum Zdrowia Matki Polki /ID# 237438
City
Lodz
State/Province
Lodzkie
ZIP/Postal Code
93-338
Country
Poland
Individual Site Status
Completed
Facility Name
Specjalistyczne Gabinety Sp. z o.o. /ID# 236347
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
30-539
Country
Poland
Individual Site Status
Completed
Facility Name
Centrum Zdrowia MDM /ID# 237269
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
00-635
Country
Poland
Individual Site Status
Completed
Facility Name
Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 234311
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
04-730
Country
Poland
Individual Site Status
Completed
Facility Name
Copertnicus Podmiot Leczniczy Sp. z o.o. /ID# 235656
City
Gdansk
ZIP/Postal Code
80-803
Country
Poland
Individual Site Status
Completed
Facility Name
Korczowski Bartosz Gabinet Lekarski /ID# 234683
City
Rzeszow
ZIP/Postal Code
35-302
Country
Poland
Individual Site Status
Completed
Facility Name
Manchester University NHS Foundation Trust /ID# 234663
City
Manchester
State/Province
Lancashire
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Individual Site Status
Completed
Facility Name
Blackpool Teaching Hospitals NHS Foundation Trust /ID# 237273
City
Blackpool
ZIP/Postal Code
FY3 8NR
Country
United Kingdom
Individual Site Status
Completed
Facility Name
King's College Hospital NHS Foundation Trust /ID# 236305
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Individual Site Status
Completed

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD Sharing Time Frame
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD Sharing Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD Sharing URL
https://vivli.org/ourmember/abbvie/

Learn more about this trial

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

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