A Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children Ages 7-17 Years, With Irritable Bowel Syndrome With Constipation
NCT ID: NCT02559817
Last Updated: 2020-12-28
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
101 participants
INTERVENTIONAL
2015-11-01
2019-08-30
Brief Summary
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This study includes up to a 4-week Screening Period, and a 2 to 3-week Pretreatment Period. Patients age 7-11 will receive oral liquid or oral solid capsule and patients 12-17 will receive solid oral capsule formulation. Children ages 7-11 years meeting the entry criteria will be randomized to 1 of 3 doses of linaclotide or placebo for 4 weeks. Children ages 12-17 years meeting the entry criteria will be randomized to 1 of 4 doses of linaclotide or placebo for 4 weeks.
This 4-week study will assess the effects of linaclotide on bowel movement frequency, as well as other bowel symptoms of IBS-C.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Linaclotide Dose A
Taken once daily each morning at least 30 minutes before breakfast, with the exception of the first Treatment Period dose which will be taken at the study center, after at least a 2-hour fast.
Dose A: 18 micrograms liquid oral solution or solid oral capsule in children 7-11 years of age with weight 18 to \<35 kg
Dose A: 36 micrograms liquid oral solution or solid oral capsule in children 7-11 years of age with weight ≥ 35 kg
Dose A: 36 micrograms solid oral capsule in children 12-17 years of age
Linaclotide Dose A
Linaclotide Dose B
Taken once daily each morning at least 30 minutes before breakfast, with the exception of the first Treatment Period dose which will be taken at the study center, after at least a 2-hour fast.
Dose B: 36 micrograms liquid oral solution or solid oral capsule in children 7-11 years of age with weight 18 to \<35 kg
Dose B: 72 micrograms liquid oral solution or solid oral capsule in children 7-11 years of age with weight ≥ 35 kg
Dose B: 72 micrograms solid oral capsule in children 12-17 years of age
Linaclotide Dose B
Linaclotide Dose C
Taken once daily each morning at least 30 minutes before breakfast, with the exception of the first Treatment Period dose which will be taken at the study center, after at least a 2-hour fast.
Dose C: 72 micrograms liquid oral solution or solid oral capsule in children 7-11 years of age with weight 18 to \<35 kg
Dose C: 145 micrograms liquid oral solution or solid oral capsule in children 7-11 years of age with weight ≥ 35 kg
Dose C: 145 micrograms solid oral capsule in children 12-17 years of age
Linaclotide Dose C
Linaclotide Approved Adult Dose
Taken once daily each morning at least 30 minutes before breakfast, with the exception of the first Treatment Period dose which will be taken at the study center, after at least a 2-hour fast.
Approved Adult Dose: 290 micrograms solid oral capsule in children 12-17 years of age
Linaclotide Approved Adult Dose
Matching Placebo
Taken once daily each morning at least 30 minutes before breakfast, with the exception of the first Treatment Period dose which will be taken at the study center, after at least a 2-hour fast
Placebo liquid oral solution or placebo solid oral capsule in children 7-11 years of age
Placebo solid oral capsule in children 12-17 years of age
Matching Placebo
Interventions
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Linaclotide Dose A
Linaclotide Dose B
Linaclotide Dose C
Linaclotide Approved Adult Dose
Matching Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient meets Rome III criteria for child/adolescent IBS: at least once per week for at least 2 months before Screening Visit, the patient 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
* Patient meets modified Rome III criteria for child/adolescent Functional Constipation (FC): For at least 2 months before the Screening Visit, the patient 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, patient meets 1 or more of the following:
* a) History of retentive posturing or excessive volitional stool retention
* b) History of painful or hard bowel movements (BMs)
* c) Presence of a large fecal mass in the rectum
* d) History of large diameter stools that may obstruct the toilet
* Patient is willing to discontinue any laxatives used before the Pretreatment Visit in favor of the protocol-permitted rescue medicine
* Patient has an average of fewer than 3 spontaneous BMs (SBMs) per week during the 14 days before the randomization day and up to the randomization. An SBM is defined as a BM that occurs in the absence of laxative, enema, or suppository use on the calendar day of the BM or the calendar day before the BM
* Patient or parent/guardian/LAR or caregiver is compliant with eDiary by completing both the morning and evening assessments for 10 out of the 14 days immediately preceding the Randomization Visit
Exclusion Criteria
* Select medical history or conditions that may be related to other causes of constipation or may interfere with safety and efficacy analyses
* Patient has required manual disimpaction anytime prior to randomization or disimpaction during in-patient hospitalization within one year prior to randomization
* Patient is unable to tolerate the placebo during rhe Screening Period
7 Years
17 Years
ALL
No
Sponsors
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Ironwood Pharmaceuticals, Inc.
INDUSTRY
Forest Laboratories
INDUSTRY
Responsible Party
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Principal Investigators
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Anna Muslin
Role: STUDY_CHAIR
Forest Laboratories, LLC, an Allergan Affiliate
Locations
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HealthStar Research, LLC
Hot Springs, Arkansas, United States
Applied Research Center of Arkansas
Little Rock, Arkansas, United States
Advanced Research Center - Site 069
Anaheim, California, United States
Kindred Medical Institute for Clinical Trials, LLC
Corona, California, United States
WCCT Global, LLC
Costa Mesa, California, United States
ACTCA, Inc
Los Angeles, California, United States
Children's Hospital Los Angeles
Los Angeles, California, United States
Center for Clinical Trials, LLC
Paramount, California, United States
University of California at San Francisco
San Francisco, California, United States
Advanced Medical Research Center
Miami, Florida, United States
Children's Center for Digestive Health Care LLC
Atlanta, Georgia, United States
Sleepcare Clinical Research Institute
Stockbridge, Georgia, United States
Methodist Medical Center
Peoria, Illinois, United States
Riley Hospital for Children at Indiana University Health
Indianapolis, Indiana, United States
Heartland Research Associates, LLC
Wichita, Kansas, United States
Willis-Knighton Physician Network
Shreveport, Louisiana, United States
Certified Research Consultants Virgo/Carter Pediatrics
Silver Spring, Maryland, United States
GI Associates and Endoscopy Center
Jackson, Mississippi, United States
Children's Mercy Hospital
Kansas City, Missouri, United States
Boys Town National Research Hospital
Boys Town, Nebraska, United States
Midwest Children Health Research Institute
Lincoln, Nebraska, United States
Midwest Children Health Research Institute
Lincoln, Nebraska, United States
Goryeb Children's Hospital
Morristown, New Jersey, United States
Columbia University Medical Center and Morgan Stanley Children's Hospital of New York
New York, New York, United States
Asheboro Research Associates - Site 022
Asheboro, North Carolina, United States
Capital Pediatrics and Adolescent Center PLLC
Raleigh, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Ohio Pediatric Research Association
Dayton, Ohio, United States
IPS Research Company
Oklahoma City, Oklahoma, United States
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States
Preferred Primary Care Physicians, Inc.
Pittsburgh, Pennsylvania, United States
Frontier Clinical Research, LLC
Scottdale, Pennsylvania, United States
Montgomery Medical Inc.
Smithfield, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Coastal Pediatric Research
Charleston, South Carolina, United States
Coastal Pediatrics Associates
Mt. Pleasant, South Carolina, United States
Cook Children's Medical Center
Fort Worth, Texas, United States
Texas Children's Hospital/Baylor College Medicine
Houston, Texas, United States
Houston Clinical Research Associates
Houston, Texas, United States
Sun Research Institute
San Antonio, Texas, United States
ClinPoint Trials
Waxahachie, Texas, United States
Children's Hospital of The King's Daughters
Norfolk, Virginia, United States
Virginia Tech Carilion School of Medicine Pediatric Gastroenterology
Roanoke, Virginia, United States
MultiCare Institute for Research and Innovation
Tacoma, Washington, United States
Aurora Health Care, Aurora Medical Center in Summit
Summit, Wisconsin, United States
Children's Hospital of Western Ontario
London, Ontario, Canada
Physician's Clinical Research Inc.
Vaughan, Ontario, Canada
Countries
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References
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Di Lorenzo C, Nurko S, Hyams JS, Rodriguez-Araujo G, Shakhnovich V, Saps M, Simon M. Safety and efficacy of linaclotide in children aged 7-17 years with irritable bowel syndrome with constipation. J Pediatr Gastroenterol Nutr. 2024 Mar;78(3):539-547. doi: 10.1002/jpn3.12103. Epub 2023 Dec 28.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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LIN-MD-63
Identifier Type: -
Identifier Source: org_study_id