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Long-term Safety of Linaclotide in Pediatric Participants With FC or IBS-C

Primary Purpose

Irritable Bowel Syndrome With Constipation, Functional Constipation

Status
Enrolling by invitation
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Irritable Bowel Syndrome with Constipation (IBS-C) participants (LIN-MD-63 completers)
Functional Constipation (FC) participants (LIN-MD-62 and LIN-MD-64 completers)
Sponsored by
Allergan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome With Constipation

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participant weighs ≥ 18 kg at the time the parent/guardian/LAR and/or caregiver has provided signed consent.
  • Female participants who have had their first menstrual period and are sexually active must agree to use a reliable form of contraception.
  • Participants must have completed study intervention in their lead-in study.

Inclusion Criteria for Phase 2 LIN-MD-62 or Phase 2 LIN-MD-63 and Phase 3 LIN-MD-64 completers who enroll in LIN-MD-66 after >28 days from last study intervention:

  • Female participants of childbearing potential must have a negative serum pregnancy test at the Screening Visit (Visit 1) and negative urine pregnancy test prior to the first dose on the Day 1 Visit (Visit 2).
  • LIN-MD-63 completers only: Participants meet Rome III criteria for child/adolescent IBS: At least once per week for at least 2 months before the LIN-MD-66 Screening Visit (Visit 1), the participant has experienced abdominal discomfort (an uncomfortable sensation not described as pain) or pain associated with 2 or more of the following at least 25% of the time:

    • a) Improvement with defecation
    • b) Onset associated with a change in frequency of stool
    • c) Onset associated with a change in form (appearance) of stool
  • Participants meet modified Rome III criteria for child/adolescent FC: For at least 2 months before the LIN-MD-66 Screening Visit (Visit 1), the participant has had 2 or fewer defecations (with each defecation occurring in the absence of any laxative, suppository, or enema use during the preceding 24 hours) in the toilet per week. In addition, at least once per week, participant meets 1 or more of the following:

    • a) History of retentive posturing or excessive volitional stool retention
    • b) History of painful or hard BMs
    • c) Presence of a large fecal mass in the rectum
    • d) History of large diameter stools that may obstruct the toilet
    • e) At least 1 episode of fecal incontinence per week

Exclusion Criteria:

  • Participant has a known allergy or sensitivity to the study intervention or its components or other medications in the same drug class.
  • Participant received an investigational drug, other than linaclotide, during the 30 days before the Screening Visit (Visit 1) or is planning to receive an investigational drug (other than that administered during this study) or use an investigational device at any time during the study.
  • Female participants who are currently pregnant or nursing, or plan to become pregnant or nurse during the clinical study.
  • Participant has required manual disimpaction any time prior to study intervention or disimpaction during in-patient hospitalization within 1 year prior to study intervention.
  • Participant has any of the following conditions:

    • a) Down's syndrome or any other chromosomal disorder
    • b) Anatomic malformations (eg, imperforate anus, anal stenosis, anterior displaced anus)
    • c) Intestinal nerve or muscle disorders (eg, Hirschprung disease, visceral myopathies, visceral neuropathies)
    • d) Neuropathic conditions (eg, spinal cord abnormalities, neurofibromatosis, tethered cord, spinal cord trauma)
    • e) Neurodevelopmental disabilities (early-onset, chronic disorders that share the essential feature of a predominant disturbance in the acquisition of cognitive, motor, language, or social skills, which has a significant and continuing impact on the developmental progress of an individual) producing a cognitive delay that precludes comprehension by the participant.
  • Participant has a mechanical bowel obstruction or pseudo-obstruction.
  • Participant currently has both unexplained and clinically significant alarm symptoms (lower GI bleeding [rectal bleeding or heme-positive stool], iron-deficiency anemia, or any unexplained anemia, or weight loss) and systemic signs of infection or colitis, or any neoplastic process.
  • Participant has an active anal fissure (Note: history of anal fissure is not an exclusion).
  • Participant has had surgery that meets any of the following criteria:

    • a) Bariatric surgery for treatment of obesity, or surgery to remove a segment of the GI tract at any time before the Screening Visit (Visit 1).
    • b) Surgery of the abdomen, pelvis, or retroperitoneal structures during the 6 months before the Screening Visit (Visit 1)
    • c) An appendectomy or cholecystectomy during the 60 days before the Screening Visit
    • d) Other major surgery during the 30 days before the Screening Visit (Visit 1)
  • Participant is receiving enteral tube feeding
  • Participants who have positive urine drug screen results for cocaine, barbiturates, opiates, or cannabinoids will be excluded from study participation.

Exclusion Criteria for LIN-MD-62, LIN-MD-63 and LIN-MD-64 Completers Who Enroll in LIN-MD-66 > 28 Days From Last Study Intervention:

  • Participant has a history of nonretentive fecal incontinence
  • For LIN-MD-62 and LIN-MD-64 completers only:

Participant meets Rome III criteria for child/adolescent IBS: at least once per week for at least 2 months before Screening (Visit 1), the participant has experienced abdominal discomfort (an uncomfortable sensation not described as pain) or pain associated with 2 or more of the following at least 25% of the time:

  • a) Improvement with defecation
  • b) Onset associated with a change in the frequency of stool
  • c) Onset associated with a change in form (appearance) of stool

    • Participant has a history of drug or alcohol abuse
    • Participant has any of the following conditions:
  • a) Celiac disease, or positive serological test for celiac disease and the condition has not been ruled out by endoscopic biopsy
  • b) Cystic fibrosis
  • c) Hypothyroidism that is untreated or treated with thyroid hormone at a dose that has not been stable for at least 3 months prior to the Screening (Visit 1)
  • d) Lead toxicity, hypercalcemia
  • e) Inflammatory bowel disease
  • f) Childhood functional abdominal pain syndrome
  • g) Childhood functional abdominal pain
  • h) Poorly treated or poorly controlled psychiatric disorders that might influence his or her ability to participate in the study
  • i) Lactose intolerance that is associated with abdominal pain or discomfort and could confound the assessments in this study
  • j) History of cancer other than treated basal cell carcinoma of the skin. (Note: Participants with a history of cancer are allowed provided that the malignancy has been in a complete remission for at least 5 years before the Randomization Visit. A complete remission is defined as the disappearance of all signs of cancer in response to treatment.)
  • k) History of diabetic neuropathy

    • Participants who have positive urine drug screen results for cocaine, barbiturates, opiates, or cannabinoids.

Sites / Locations

  • Central Research Associates /ID# 237953
  • G & L Research, LLC /ID# 238093
  • The Center for Clinical Trials Inc. /ID# 234605
  • HealthStar Research of Hot Springs PLLC /ID# 234608
  • Preferred Research Partners /ID# 237109
  • Applied Research Center of Arkansas /ID# 238069
  • Advanced Research Center /ID# 237960
  • Kindred Medical Institute, LLC /ID# 237367
  • Center for Clinical Trials LLC /ID# 234629
  • Medical Ctr for Clin Research /ID# 236911
  • Lynn Institute of Denver /ID# 238086
  • Children's National Medical Center /ID# 234417
  • Prohealth Research Center /ID# 234659
  • Dolphin Medical Research /ID# 234676
  • Amedica Research Institute Inc /ID# 234666
  • Nemours Childrens Specialty Care /ID# 237991
  • Elite Clinical Research /ID# 234651
  • My Preferred Research LLC /ID# 237943
  • South Miami Medical & Research Group Inc. /ID# 234654
  • Valencia Medical & Research Center /ID# 234671
  • Advanced Research for Health Improvement /ID# 238253
  • Pediatric & Adult Research Center /ID# 234681
  • Nemours Children's Hospital /ID# 234429
  • Oviedo Medical Research /ID# 234692
  • Treken Primary Care /ID# 234645
  • Children's Healthcare of Atlanta - Ferry Rd /ID# 237005
  • Children's Ctr Digestive, US /ID# 237574
  • River Birch Research Alliance /ID# 237963
  • Clinical Research Institute /ID# 234702
  • Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 236342
  • KU Wichita Center for Clinical Research /ID# 234500
  • Michael W. Simon, MD, PSC /ID# 236516
  • Virgo Carter Pediatrics /ID# 234518
  • MNGI Digestive Health, P. A. /ID# 234437
  • GI associates and Endoscopy Ce /ID# 237969
  • David M. Headley, MD, P.A. /ID# 238216
  • Private Practice - Dr. Craig Spiegel /ID# 234545
  • Medclinical Research Partners LLC/ Foundation Pediatrics /ID# 234566
  • University of New Mexico /ID# 236983
  • Advantage Clinical Trials /ID# 237932
  • Columbia University Medical Center and Morgan Stanley Children's Hospital of NY /ID# 235686
  • East Carolina University Brody School of Medicine /ID# 237509
  • PMG Research of Piedmont Healthcare-Statesville /ID# 238257
  • Univ Oklahoma HSC /ID# 237546
  • IPS Research Company /ID# 237669
  • Frontier Clinical Research, LLC - Scottdale /ID# 238022
  • Frontier Clinical Research /ID# 237923
  • Rhode Island Hospital /ID# 237861
  • Coastal Pediatric Research - West Ashley B /ID# 234678
  • Coastal Pediatric Research - Summerville /ID# 234674
  • The Jackson Clinic, PA /ID# 236772
  • Accellacare of Knoxville /ID# 234462
  • Cook Children's Med. Center /ID# 237536
  • Valley Institute of Research /ID# 234475
  • Vilo Research Group Inc /ID# 238228
  • Cullen Research /ID# 234482
  • Pioneer Research Solutions - Houston /ID# 236935
  • AIM Trials /ID# 236364
  • Sun Research Institute /ID# 236932
  • ClinPoint Trials /ID# 236615
  • Chrysalis Clinical Research /ID# 234515
  • Office of Maria Ona /ID# 234539
  • Health Research of Hampton Roads, Inc. (HRHR) /ID# 237252
  • Clinical Research Partners, LLC /ID# 237158
  • Multicare Institute for Research and Innovation /ID# 236979
  • London Health Sciences Center /ID# 234309
  • Bluewater Clinical Research Group Inc /ID# 234618
  • Stouffville Medical Centre /ID# 234619
  • The Chaim Sheba Medical Center /ID# 236760
  • Hadassah Hebrew University Hospital - Ein Kerem /ID# 234735
  • The Baruch Padeh Medical Center Poriya /ID# 234768
  • Academisch Medisch Centrum /ID# 237116

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

72 μg linaclotide

145 μg linaclotide

290 μg linaclotide

Arm Description

An oral capsule that is taken once daily. It may be taken whole or sprinkled into 1 teaspoonful of applesauce or 30mL of bottled water.

An oral capsule that is taken once daily. It may be taken whole or sprinkled into 1 teaspoonful of applesauce or 30mL of bottled water.

An oral capsule that is taken once daily. It may be taken whole or sprinkled into 1 teaspoonful of applesauce or 30mL of bottled water.

Outcomes

Primary Outcome Measures

Incidence of Treatment Emergent Adverse Events
Number of Participants With Treatment-Emergent Adverse Events (TEAEs).

Secondary Outcome Measures

Full Information

First Posted
November 11, 2019
Last Updated
June 26, 2023
Sponsor
Allergan
Collaborators
Ironwood Pharmaceuticals, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT04166058
Brief Title
Long-term Safety of Linaclotide in Pediatric Participants With FC or IBS-C
Official Title
A Phase 3, Open-label, Long-term Safety Study of Oral Linaclotide Administered to Pediatric Participants With Functional Constipation (FC) or Irritable Bowel Syndrome With Constipation (IBS-C)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
November 19, 2019 (Actual)
Primary Completion Date
July 29, 2024 (Anticipated)
Study Completion Date
July 29, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
Collaborators
Ironwood Pharmaceuticals, Inc.

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
LIN-MD-66 is a Phase 3 open-label study with 24 weeks (Functional Constipation participants) or 52 weeks (Irritable bowel syndrome with constipation participants) of linaclotide exposure that will enroll pediatric participants (6-17 years of age) with FC or IBS-C who completed study intervention in studies LIN-MD-62, LIN-MD-63, orLIN-MD-64 based on the individual study criteria.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome With Constipation, Functional Constipation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
72 μg linaclotide
Arm Type
Active Comparator
Arm Description
An oral capsule that is taken once daily. It may be taken whole or sprinkled into 1 teaspoonful of applesauce or 30mL of bottled water.
Arm Title
145 μg linaclotide
Arm Type
Active Comparator
Arm Description
An oral capsule that is taken once daily. It may be taken whole or sprinkled into 1 teaspoonful of applesauce or 30mL of bottled water.
Arm Title
290 μg linaclotide
Arm Type
Active Comparator
Arm Description
An oral capsule that is taken once daily. It may be taken whole or sprinkled into 1 teaspoonful of applesauce or 30mL of bottled water.
Intervention Type
Drug
Intervention Name(s)
Irritable Bowel Syndrome with Constipation (IBS-C) participants (LIN-MD-63 completers)
Intervention Description
Participants whom are between the ages of 7-11 years old at their time of enrollment will be assigned a dose (72 μg or 145 μg) based on their weight. Randomized doses (145 μg or 290 μg) will be assigned to participants whom are 12-17 years old at the time of enrollment.
Intervention Type
Drug
Intervention Name(s)
Functional Constipation (FC) participants (LIN-MD-62 and LIN-MD-64 completers)
Intervention Description
Participants whom are between the ages of 6-11 years old at their time of enrollment will be assigned a dose of 72 μg. Randomized doses (72 μg or 145 μg) will be assigned to participants whom are 12-17 years old at the time of enrollment.
Primary Outcome Measure Information:
Title
Incidence of Treatment Emergent Adverse Events
Description
Number of Participants With Treatment-Emergent Adverse Events (TEAEs).
Time Frame
24 to 52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participant weighs ≥ 18 kg at the time the parent/guardian/LAR and/or caregiver has provided signed consent. Female participants who have had their first menstrual period and are sexually active must agree to use a reliable form of contraception. Participants must have completed study intervention in their lead-in study. Inclusion Criteria for Phase 2 LIN-MD-62 or Phase 2 LIN-MD-63 and Phase 3 LIN-MD-64 completers who enroll in LIN-MD-66 after >28 days from last study intervention: Female participants of childbearing potential must have a negative serum pregnancy test at the Screening Visit (Visit 1) and negative urine pregnancy test prior to the first dose on the Day 1 Visit (Visit 2). LIN-MD-63 completers only: Participants meet Rome III criteria for child/adolescent IBS: At least once per week for at least 2 months before the LIN-MD-66 Screening Visit (Visit 1), the participant has experienced abdominal discomfort (an uncomfortable sensation not described as pain) or pain associated with 2 or more of the following at least 25% of the time: a) Improvement with defecation b) Onset associated with a change in frequency of stool c) Onset associated with a change in form (appearance) of stool Participants meet modified Rome III criteria for child/adolescent FC: For at least 2 months before the LIN-MD-66 Screening Visit (Visit 1), the participant has had 2 or fewer defecations (with each defecation occurring in the absence of any laxative, suppository, or enema use during the preceding 24 hours) in the toilet per week. In addition, at least once per week, participant meets 1 or more of the following: a) History of retentive posturing or excessive volitional stool retention b) History of painful or hard BMs c) Presence of a large fecal mass in the rectum d) History of large diameter stools that may obstruct the toilet e) At least 1 episode of fecal incontinence per week Exclusion Criteria: Participant has a known allergy or sensitivity to the study intervention or its components or other medications in the same drug class. Participant received an investigational drug, other than linaclotide, during the 30 days before the Screening Visit (Visit 1) or is planning to receive an investigational drug (other than that administered during this study) or use an investigational device at any time during the study. Female participants who are currently pregnant or nursing, or plan to become pregnant or nurse during the clinical study. Participant has required manual disimpaction any time prior to study intervention or disimpaction during in-patient hospitalization within 1 year prior to study intervention. Participant has any of the following conditions: a) Down's syndrome or any other chromosomal disorder b) Anatomic malformations (eg, imperforate anus, anal stenosis, anterior displaced anus) c) Intestinal nerve or muscle disorders (eg, Hirschprung disease, visceral myopathies, visceral neuropathies) d) Neuropathic conditions (eg, spinal cord abnormalities, neurofibromatosis, tethered cord, spinal cord trauma) e) Neurodevelopmental disabilities (early-onset, chronic disorders that share the essential feature of a predominant disturbance in the acquisition of cognitive, motor, language, or social skills, which has a significant and continuing impact on the developmental progress of an individual) producing a cognitive delay that precludes comprehension by the participant. Participant has a mechanical bowel obstruction or pseudo-obstruction. Participant currently has both unexplained and clinically significant alarm symptoms (lower GI bleeding [rectal bleeding or heme-positive stool], iron-deficiency anemia, or any unexplained anemia, or weight loss) and systemic signs of infection or colitis, or any neoplastic process. Participant has an active anal fissure (Note: history of anal fissure is not an exclusion). Participant has had surgery that meets any of the following criteria: a) Bariatric surgery for treatment of obesity, or surgery to remove a segment of the GI tract at any time before the Screening Visit (Visit 1). b) Surgery of the abdomen, pelvis, or retroperitoneal structures during the 6 months before the Screening Visit (Visit 1) c) An appendectomy or cholecystectomy during the 60 days before the Screening Visit d) Other major surgery during the 30 days before the Screening Visit (Visit 1) Participant is receiving enteral tube feeding Participants who have positive urine drug screen results for cocaine, barbiturates, opiates, or cannabinoids will be excluded from study participation. Exclusion Criteria for LIN-MD-62, LIN-MD-63 and LIN-MD-64 Completers Who Enroll in LIN-MD-66 > 28 Days From Last Study Intervention: Participant has a history of nonretentive fecal incontinence For LIN-MD-62 and LIN-MD-64 completers only: Participant meets Rome III criteria for child/adolescent IBS: at least once per week for at least 2 months before Screening (Visit 1), the participant has experienced abdominal discomfort (an uncomfortable sensation not described as pain) or pain associated with 2 or more of the following at least 25% of the time: a) Improvement with defecation b) Onset associated with a change in the frequency of stool c) Onset associated with a change in form (appearance) of stool Participant has a history of drug or alcohol abuse Participant has any of the following conditions: a) Celiac disease, or positive serological test for celiac disease and the condition has not been ruled out by endoscopic biopsy b) Cystic fibrosis c) Hypothyroidism that is untreated or treated with thyroid hormone at a dose that has not been stable for at least 3 months prior to the Screening (Visit 1) d) Lead toxicity, hypercalcemia e) Inflammatory bowel disease f) Childhood functional abdominal pain syndrome g) Childhood functional abdominal pain h) Poorly treated or poorly controlled psychiatric disorders that might influence his or her ability to participate in the study i) Lactose intolerance that is associated with abdominal pain or discomfort and could confound the assessments in this study j) History of cancer other than treated basal cell carcinoma of the skin. (Note: Participants with a history of cancer are allowed provided that the malignancy has been in a complete remission for at least 5 years before the Randomization Visit. A complete remission is defined as the disappearance of all signs of cancer in response to treatment.) k) History of diabetic neuropathy Participants who have positive urine drug screen results for cocaine, barbiturates, opiates, or cannabinoids.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ALLERGAN INC.
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
Central Research Associates /ID# 237953
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
G & L Research, LLC /ID# 238093
City
Foley
State/Province
Alabama
ZIP/Postal Code
36535
Country
United States
Facility Name
The Center for Clinical Trials Inc. /ID# 234605
City
Saraland
State/Province
Alabama
ZIP/Postal Code
36571
Country
United States
Facility Name
HealthStar Research of Hot Springs PLLC /ID# 234608
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
Preferred Research Partners /ID# 237109
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Applied Research Center of Arkansas /ID# 238069
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72212-4187
Country
United States
Facility Name
Advanced Research Center /ID# 237960
City
Anaheim
State/Province
California
ZIP/Postal Code
92805
Country
United States
Facility Name
Kindred Medical Institute, LLC /ID# 237367
City
Corona
State/Province
California
ZIP/Postal Code
92879
Country
United States
Facility Name
Center for Clinical Trials LLC /ID# 234629
City
Paramount
State/Province
California
ZIP/Postal Code
90723
Country
United States
Facility Name
Medical Ctr for Clin Research /ID# 236911
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Lynn Institute of Denver /ID# 238086
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
Children's National Medical Center /ID# 234417
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010-2916
Country
United States
Facility Name
Prohealth Research Center /ID# 234659
City
Doral
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
Dolphin Medical Research /ID# 234676
City
Doral
State/Province
Florida
ZIP/Postal Code
33172
Country
United States
Facility Name
Amedica Research Institute Inc /ID# 234666
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33013
Country
United States
Facility Name
Nemours Childrens Specialty Care /ID# 237991
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Elite Clinical Research /ID# 234651
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
My Preferred Research LLC /ID# 237943
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
South Miami Medical & Research Group Inc. /ID# 234654
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Valencia Medical & Research Center /ID# 234671
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Facility Name
Advanced Research for Health Improvement /ID# 238253
City
Naples
State/Province
Florida
ZIP/Postal Code
34102-5430
Country
United States
Facility Name
Pediatric & Adult Research Center /ID# 234681
City
Orlando
State/Province
Florida
ZIP/Postal Code
32825
Country
United States
Facility Name
Nemours Children's Hospital /ID# 234429
City
Orlando
State/Province
Florida
ZIP/Postal Code
32827-7884
Country
United States
Facility Name
Oviedo Medical Research /ID# 234692
City
Oviedo
State/Province
Florida
ZIP/Postal Code
32765
Country
United States
Facility Name
Treken Primary Care /ID# 234645
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30315
Country
United States
Facility Name
Children's Healthcare of Atlanta - Ferry Rd /ID# 237005
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342-1605
Country
United States
Facility Name
Children's Ctr Digestive, US /ID# 237574
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
River Birch Research Alliance /ID# 237963
City
Blue Ridge
State/Province
Georgia
ZIP/Postal Code
30513
Country
United States
Facility Name
Clinical Research Institute /ID# 234702
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Facility Name
Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 236342
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Facility Name
KU Wichita Center for Clinical Research /ID# 234500
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Michael W. Simon, MD, PSC /ID# 236516
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40517
Country
United States
Facility Name
Virgo Carter Pediatrics /ID# 234518
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
20910
Country
United States
Facility Name
MNGI Digestive Health, P. A. /ID# 234437
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55413-2195
Country
United States
Facility Name
GI associates and Endoscopy Ce /ID# 237969
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Facility Name
David M. Headley, MD, P.A. /ID# 238216
City
Port Gibson
State/Province
Mississippi
ZIP/Postal Code
39150-2024
Country
United States
Facility Name
Private Practice - Dr. Craig Spiegel /ID# 234545
City
Bridgeton
State/Province
Missouri
ZIP/Postal Code
63044
Country
United States
Facility Name
Medclinical Research Partners LLC/ Foundation Pediatrics /ID# 234566
City
East Orange
State/Province
New Jersey
ZIP/Postal Code
07018
Country
United States
Facility Name
University of New Mexico /ID# 236983
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102-4517
Country
United States
Facility Name
Advantage Clinical Trials /ID# 237932
City
Bronx
State/Province
New York
ZIP/Postal Code
10468
Country
United States
Facility Name
Columbia University Medical Center and Morgan Stanley Children's Hospital of NY /ID# 235686
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
East Carolina University Brody School of Medicine /ID# 237509
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
PMG Research of Piedmont Healthcare-Statesville /ID# 238257
City
Statesville
State/Province
North Carolina
ZIP/Postal Code
28625
Country
United States
Facility Name
Univ Oklahoma HSC /ID# 237546
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
IPS Research Company /ID# 237669
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73106
Country
United States
Facility Name
Frontier Clinical Research, LLC - Scottdale /ID# 238022
City
Scottdale
State/Province
Pennsylvania
ZIP/Postal Code
15683
Country
United States
Facility Name
Frontier Clinical Research /ID# 237923
City
Smithfield
State/Province
Pennsylvania
ZIP/Postal Code
15478
Country
United States
Facility Name
Rhode Island Hospital /ID# 237861
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Coastal Pediatric Research - West Ashley B /ID# 234678
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
Coastal Pediatric Research - Summerville /ID# 234674
City
Summerville
State/Province
South Carolina
ZIP/Postal Code
29486
Country
United States
Facility Name
The Jackson Clinic, PA /ID# 236772
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Accellacare of Knoxville /ID# 234462
City
Jefferson City
State/Province
Tennessee
ZIP/Postal Code
37760
Country
United States
Facility Name
Cook Children's Med. Center /ID# 237536
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Valley Institute of Research /ID# 234475
City
Harlingen
State/Province
Texas
ZIP/Postal Code
78550
Country
United States
Facility Name
Vilo Research Group Inc /ID# 238228
City
Houston
State/Province
Texas
ZIP/Postal Code
77017-2337
Country
United States
Facility Name
Cullen Research /ID# 234482
City
Houston
State/Province
Texas
ZIP/Postal Code
77051
Country
United States
Facility Name
Pioneer Research Solutions - Houston /ID# 236935
City
Houston
State/Province
Texas
ZIP/Postal Code
77099-4307
Country
United States
Facility Name
AIM Trials /ID# 236364
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Sun Research Institute /ID# 236932
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
ClinPoint Trials /ID# 236615
City
Waxahachie
State/Province
Texas
ZIP/Postal Code
75165-1430
Country
United States
Facility Name
Chrysalis Clinical Research /ID# 234515
City
Saint George
State/Province
Utah
ZIP/Postal Code
84790
Country
United States
Facility Name
Office of Maria Ona /ID# 234539
City
Franklin
State/Province
Virginia
ZIP/Postal Code
23851
Country
United States
Facility Name
Health Research of Hampton Roads, Inc. (HRHR) /ID# 237252
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States
Facility Name
Clinical Research Partners, LLC /ID# 237158
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23220-4459
Country
United States
Facility Name
Multicare Institute for Research and Innovation /ID# 236979
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
London Health Sciences Center /ID# 234309
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Facility Name
Bluewater Clinical Research Group Inc /ID# 234618
City
Sarnia
State/Province
Ontario
ZIP/Postal Code
N7T 4X3
Country
Canada
Facility Name
Stouffville Medical Centre /ID# 234619
City
Stouffville
State/Province
Ontario
ZIP/Postal Code
L4A 1H2
Country
Canada
Facility Name
The Chaim Sheba Medical Center /ID# 236760
City
Ramat Gan
State/Province
Tel-Aviv
ZIP/Postal Code
5265601
Country
Israel
Facility Name
Hadassah Hebrew University Hospital - Ein Kerem /ID# 234735
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
The Baruch Padeh Medical Center Poriya /ID# 234768
City
Lower Galilee
ZIP/Postal Code
15208
Country
Israel
Facility Name
Academisch Medisch Centrum /ID# 237116
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands

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/
Links:
URL
http://www.AllerganClinicalTrials.com
Description
Additional information on study locations near you may be found at AllerganClinicalTrials.com.

Learn more about this trial

Long-term Safety of Linaclotide in Pediatric Participants With FC or IBS-C

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