A Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children Ages 6-17 Years Who Fulfill Modified Rome III Criteria for Child/Adolescent Functional Constipation (FC)
NCT ID: NCT02559570
Last Updated: 2019-06-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
173 participants
INTERVENTIONAL
2015-11-03
2018-05-29
Brief Summary
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Children ages 6-11 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 FC.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Participants aged 6 to 11 or 12 to 17 years received matching placebo linaclotide (LIN), 30 minutes before evening meal, once daily for 4 weeks. Administered as liquid oral solution for participants 6 to 11 years of age and solid oral capsule or liquid oral solution for participants 12 to 17 years of age.
Placebo
Participants received matching placebo LIN liquid solution or solid capsules, orally, 30 minutes before evening meal, once daily for 4 weeks.
LIN Dose A (9 ug or 18 ug)
Participants aged 6 to 11 years with weight 18 to \<35 kg received LIN 9 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 6 to 11 years with weight ≥35 kg received LIN 18 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 12 to 17 years received LIN 18 ug, oral solution or solid capsules, 30 minutes before evening meal, once daily for 4 weeks.
LIN Dose A
Participants received LIN 9 or 18 ug liquid solution or solid capsules, orally, 30 minutes before evening meal, once daily for 4 weeks.
LIN Dose B (18 ug or 36 ug)
Participants aged 6 to 11 years with weight 18 to \<35 kg received LIN 18 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 6 to 11 years with weight ≥35 kg received LIN 36 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 12 to 17 years received LIN 36 ug, oral solution or solid capsules, 30 minutes before evening meal, once daily for 4 weeks.
LIN Dose B
Participants received LIN 18 or 36 ug liquid solution or solid capsules, orally, 30 minutes before evening meal, once daily for 4 weeks.
LIN Dose C (36 ug or 72 ug)
Participants aged 6 to 11 years with weight 18 to \<35 kg received LIN 36 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 6 to 11 years with weight ≥35 kg received LIN 72 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 12 to 17 years received LIN 72 ug, oral solution or solid capsules, 30 minutes before evening meal, once daily for 4 weeks.
LIN Dose C
Participants received LIN 36 or 72 ug liquid solution or solid capsules, orally, 30 minutes before evening meal, once daily for 4 weeks.
LIN 145 µg
Participants aged 12 to 17 years received LIN 145 ug, oral solution or solid capsules, 30 minutes before evening meal, once daily for 4 weeks.
LIN 145 µg
Participants received LIN 145 µg, liquid solution or solid capsules, 30 minutes before evening meal, once daily for 4 weeks.
Interventions
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Placebo
Participants received matching placebo LIN liquid solution or solid capsules, orally, 30 minutes before evening meal, once daily for 4 weeks.
LIN Dose A
Participants received LIN 9 or 18 ug liquid solution or solid capsules, orally, 30 minutes before evening meal, once daily for 4 weeks.
LIN Dose B
Participants received LIN 18 or 36 ug liquid solution or solid capsules, orally, 30 minutes before evening meal, once daily for 4 weeks.
LIN Dose C
Participants received LIN 36 or 72 ug liquid solution or solid capsules, orally, 30 minutes before evening meal, once daily for 4 weeks.
LIN 145 µg
Participants received LIN 145 µg, liquid solution or solid capsules, 30 minutes before evening meal, once daily for 4 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participant meets modified Rome III criteria for child/adolescent FC: For at least 2 months before the Screening Visit, 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, 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 faecal mass in the rectum
* d) History of large diameter stools that may obstruct the toilet
* e) At least one episode of fecal incontinence per week
* Participant is willing to discontinue any laxatives used before the Pretreatment Visit in favor of the protocol-permitted rescue medicine
* Participant 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
* Participant or participant/guardian/legally authorized representative (LAR) or caregiver is compliant with electronic diary (eDiary) by completing both the morning and evening assessments for 10 out of the 14 days immediately preceding the Randomization Visit
Exclusion Criteria
* 1\. Improvement with defecation
* 2\. Onset associated with a change in frequency of stool
* 3\. Onset associated with a change in form (appearance) of stool
* Participant reports having more than 1 loose, mushy stool (eDiary-recorded stool consistency of 6 on the Pediatric Bristol Stool Form Scale \[p-BSFS\]) or any watery stool (eDiary-recorded stool consistency of 7 on the p-BSFS) with any SBM that occurred in the absence of laxative use on the calendar day of the BM or the calendar day before the BM during the 14 days before the randomization day and up to the randomization
* Select medical history or conditions that may be related to other causes of constipation or may interfere with safety and efficacy analyses
* Participant has required manual or hospital-based disimpassion any time prior to randomization
* Participant is unable to tolerate the placebo during the Screening Period
6 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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Taryn Weissman
Role: STUDY_DIRECTOR
Allergan, LLC
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
Anaheim, California, United States
Kindred Medical Institute for Clinical Trials, LLC
Corona, California, United States
WCCT Global, LLC
Costa Mesa, California, United States
Ark Clinical Research
Long Beach, California, United States
ACTCA, Inc
Los Angeles, California, United States
Children's Hospital Los Angeles
Los Angeles, California, United States
Orange County Research Institute
Ontario, California, United States
Center for Clinical Trials, LLC
Paramount, California, United States
UCSD Rady Children's Hospital
San Diego, California, United States
University of California at San Francisco
San Francisco, California, United States
Ventura Clinical Trials
Ventura, California, United States
Colorado Springs Health Partners, HCP-Clinical Research, LLC
Colorado Springs, Colorado, United States
Nova Southeastern University
Fort Lauderdale, Florida, United States
Homestead Research Institute
Homestead, Florida, United States
RM Medical Research
Homestead, Florida, United States
Advanced Medical Research Center
Miami, Florida, United States
SCORE Physician Alliance, LLC
St. Petersburg, Florida, United States
Children's Center for Digestive Health Care LLC
Atlanta, Georgia, United States
Sleepcare Clinical Research Institute
Stockbridge, Georgia, United States
Riley Hospital for Children at Indiana University Health
Indianapolis, Indiana, United States
Heartland Research Associates, LLC
Wichita, Kansas, United States
Kentucky Pediatric/ Adult Research
Bardstown, Kentucky, United States
Kosair Children's Hospital - Pediatric Clinical Research Unit
Louisville, Kentucky, United States
Michael W. Simon, MD, PSC
Nicholasville, Kentucky, United States
Willis-Knighton Physician Network
Shreveport, Louisiana, United States
University of Maryland Children's Hospital
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University Of Minnesota
Minneapolis, Minnesota, United States
GI Associates and Endoscopy Center
Jackson, Mississippi, United States
Craig A. Speigel, MD
Bridgeton, Missouri, 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
New York, New York, United States
Asheboro Research Associates
Asheboro, North Carolina, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Capital Pediatrics and Adolescent Center PLLC
Raleigh, North Carolina, United States
Ohio Pediatric Research Association
Dayton, Ohio, United States
IPS Research Company
Oklahoma City, Oklahoma, United States
Pediatric Care Specialists
Johnstown, Pennsylvania, 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
Southwest Children's Research Associates, P.A.
San Antonio, Texas, United States
ClinPoint Trials
Waxahachie, Texas, United States
Foothill Family Clinic South / J. Lewis Research, Inc.
Salt Lake City, Utah, United States
Pediatric Specialists of Virginia
Fairfax, Virginia, United States
Virginia Tech Carilion School of Medicine Pediatric
Roanoke, Virginia, United States
Seattle Children's Hospital
Seattle, Washington, United States
Stollery Children's Hospital
Edmonton, Alberta, Canada
Children's Hospital of Western Ontario
London, Ontario, Canada
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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LIN-MD-62
Identifier Type: -
Identifier Source: org_study_id
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