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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) (LIN-MD-62)

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ClinicalTrials.gov Identifier: NCT02559570
Recruitment Status : Completed
First Posted : September 24, 2015
Last Update Posted : June 12, 2018
Sponsor:
Collaborator:
Ironwood Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Forest Laboratories

Brief Summary:

The purpose of this study is to evaluate the safety and efficacy of linaclotide for the treatment of functional constipation (FC), in children age 6-17 years. This study includes up to a 4-week Screening Period, and a 2 to 3-week Pretreatment Period. Patients age 6-11 will receive oral liquid formulation and patients 12-17 will receive solid oral capsule or liquid oral solution.

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.


Condition or disease Intervention/treatment Phase
Functional Constipation in Children Ages 6-17 Years Drug: Linaclotide Dose A Drug: Linaclotide Dose B Drug: Linaclotide Dose C Drug: Linaclotide Approved Adult Dose Drug: Matching Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 173 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children, Ages 6 to 17 Years, Who Fulfill Modified Rome III Criteria for Child/Adolescent Functional Constipation (FC)
Actual Study Start Date : November 1, 2015
Actual Primary Completion Date : April 20, 2018
Actual Study Completion Date : May 29, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

Arm Intervention/treatment
Experimental: 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: 9 micrograms liquid oral solution in children 6-11 years of age with weight 18 to <35 kg

Dose A: 18 micrograms liquid oral solution in children 6-11 years of age with weight ≥ 35 kg

Dose A: 18 micrograms liquid oral solution or solid oral capsule in children 12-17 years of age

Drug: Linaclotide Dose A
Other Name: Linzess

Experimental: 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: 18 micrograms liquid oral solution in children 6-11 years of age with weight 18 to <35 kg

Dose B: 36 micrograms liquid oral solution in children 6-11 years of age with weight ≥ 35 kg

Dose B: 36 micrograms liquid oral solution or solid oral capsule in children 12-17 years of age

Drug: Linaclotide Dose B
Other Name: Linzess

Experimental: 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: 36 micrograms liquid oral solution in children 6-11 years of age with weight 18 to <35 kg

Dose C: 72 micrograms liquid oral solution in children 6-11 years of age with weight ≥ 35 kg

Dose C: 72 micrograms liquid oral solution or solid oral capsule in children 12-17 years of age

Drug: Linaclotide Dose C
Other Name: Linzess

Experimental: 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: 145 micrograms oral solution or solid oral capsule in children 12-17 years of age

Drug: Linaclotide Approved Adult Dose
Other Name: Linzess

Placebo Comparator: 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 in children 6-11 years of age

Placebo solid oral capsule or placebo liquid oral solution in children 12-17 years of age

Drug: Matching Placebo
Other Name: Placebo




Primary Outcome Measures :
  1. Change from baseline in 4-week overall spontaneous bowel movement (SBM) frequency rate (SBMs/week) during the Treatment Period [ Time Frame: Baseline to week 4 ]

Secondary Outcome Measures :
  1. Change from baseline in 4-week stool consistency [ Time Frame: Baseline to week 4 ]
    Patients will use the modified Pediatric Bristol Stool Form Scale (p-BSFS) to rate their stool consistency on a 7-point ordinal scale from 1 (hard lumps) to 7 (watery stool).

  2. Change from baseline in 4-week severity of straining [ Time Frame: Baseline to week 4 ]
    Patients will assess the degree of staining on an ordinal scale from 0 (not at all) to 4 (very hard).

  3. Change from baseline in 4-week abdominal bloating daytime symptoms based on evening assessment [ Time Frame: Baseline to week 4 ]
  4. Change from baseline in 4-week overall complete spontaneous bowel movement (CSBM) frequency rate (CSBMs per Week) [ Time Frame: Baseline to week 4 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient weighs at least 18 kg (39.7 lbs)
  • Patient meets modified Rome III criteria for child/adolescent 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
  • e) At least one episode of fecal incontinence per week
  • 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:

  • Patient meets Rome III criteria for Child/Adolescent irritable bowel syndrome (IBS): At least once per week for at least 2 months before the Screening Visit, the patient 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:
  • 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
  • Patient 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
  • Patient has required manual or hospital-based disimpaction any time prior to randomization
  • Patient is unable to tolerate the placebo during the Screening Period

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02559570


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Locations
United States, Arkansas
HealthStar Research, LLC
Hot Springs, Arkansas, United States, 71913
Applied Research Center of Arkansas
Little Rock, Arkansas, United States, 72212
United States, California
Advanced Research Center
Anaheim, California, United States, 92805
Kindred Medical Institute for Clinical Trials, LLC
Corona, California, United States, 92879
WCCT Global, LLC
Costa Mesa, California, United States, 92626
Ark Clinical Research
Long Beach, California, United States, 90806
ACTCA, Inc
Los Angeles, California, United States, 90017
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
Orange County Research Institute
Ontario, California, United States, 91762
Center for Clinical Trials, LLC
Paramount, California, United States, 90723
UCSD Rady Children's Hospital
San Diego, California, United States, 92123
University of California at San Francisco
San Francisco, California, United States, 94143
Ventura Clinical Trials
Ventura, California, United States, 93003
United States, Colorado
Colorado Springs Health Partners, HCP-Clinical Research, LLC
Colorado Springs, Colorado, United States, 80922
United States, Florida
Nova Southeastern University
Fort Lauderdale, Florida, United States, 33328
Homestead Research Institute
Homestead, Florida, United States, 33030
RM Medical Research
Homestead, Florida, United States, 33030
Advanced Medical Research Center
Miami, Florida, United States, 33135
SCORE Physician Alliance, LLC
Saint Petersburg, Florida, United States, 33710
United States, Georgia
Children's Center for Digestive Health Care LLC
Atlanta, Georgia, United States, 30342
Sleepcare Clinical Research Institute
Stockbridge, Georgia, United States, 30281
United States, Illinois
Methodist Medical Center
Peoria, Illinois, United States, 61602
United States, Indiana
Riley Hospital for Children at Indiana University Health
Indianapolis, Indiana, United States, 46202
United States, Kansas
Heartland Research Associates, LLC
Wichita, Kansas, United States, 67205
United States, Kentucky
Kentucky Pediatric/ Adult Research
Bardstown, Kentucky, United States, 40004
Kosair Children's Hospital - Pediatric Clinical Research Unit
Louisville, Kentucky, United States, 40202
Michael W. Simon, MD, PSC
Nicholasville, Kentucky, United States, 40356
United States, Louisiana
Willis-Knighton Physician Network
Shreveport, Louisiana, United States, 71118
United States, Maryland
University of Maryland Children's Hospital
Baltimore, Maryland, United States, 21201
Certified Research Consultants Virgo/Carter Pediatrics
Silver Spring, Maryland, United States, 20910
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Minnesota
University Of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Mississippi
GI Associates and Endoscopy Center
Jackson, Mississippi, United States, 39202
United States, Missouri
Craig A. Speigel, MD
Bridgeton, Missouri, United States, 63044
United States, Nebraska
Boys Town National Research Hospital
Boys Town, Nebraska, United States, 68010
Midwest Children Health Research Institute
Lincoln, Nebraska, United States, 68505
Midwest Children Health Research Institute
Lincoln, Nebraska, United States, 68516
United States, New Jersey
Goryeb Children's Hospital
Morristown, New Jersey, United States, 07962
New Jersey Medical School, Rutgers University
Newark, New Jersey, United States, 07103
United States, New York
Novel Research of New York, LLC
Bronx, New York, United States, 10461
Columbia University Medical Center and Morgan Stanley
New York, New York, United States, 10032
United States, North Carolina
Asheboro Research Associates
Asheboro, North Carolina, United States, 27203
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Capital Pediatrics and Adolescent Center PLLC
Raleigh, North Carolina, United States, 27609
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Dayton Clinical Research
Dayton, Ohio, United States, 45406
Ohio Pediatric Research Association
Dayton, Ohio, United States, 45414
United States, Oklahoma
IPS Research Company
Oklahoma City, Oklahoma, United States, 73103
United States, Pennsylvania
Pediatric Care Specialists
Johnstown, Pennsylvania, United States, 15904
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States, 19134
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15224
Preferred Primary Care Physicians, Inc.
Pittsburgh, Pennsylvania, United States, 15236
Frontier Clinical Research, LLC
Scottdale, Pennsylvania, United States, 15683
Montgomery Medical Inc.
Smithfield, Pennsylvania, United States, 15478
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, South Carolina
Coastal Pediatric Research
Charleston, South Carolina, United States, 29414
Coastal Pediatrics Associates
Mount Pleasant, South Carolina, United States, 26464
United States, Texas
Cook Children's Medical Center
Fort Worth, Texas, United States, 76104
Texas Children's Hospital/Baylor College Medicine
Houston, Texas, United States, 77030
Houston Clinical Research Associates
Houston, Texas, United States, 77090
Sun Research Institute
San Antonio, Texas, United States, 78215
Southwest Children's Research Associates, P.A.
San Antonio, Texas, United States, 78229
ClinPoint Trials
Waxahachie, Texas, United States, 75165
United States, Utah
Foothill Family Clinic South / J. Lewis Research, Inc.
Salt Lake City, Utah, United States, 84121
United States, Virginia
Pediatric Specialists of Virginia
Fairfax, Virginia, United States, 22031
Virginia Tech Carilion School of Medicine Pediatric
Roanoke, Virginia, United States, 24013
United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98105
MultiCare Institute for Research and Innovation
Tacoma, Washington, United States, 98405
Canada, Alberta
Stollery Children's Hospital
Edmonton, Alberta, Canada, T6G 2B7
Canada, Ontario
Children's Hospital of Western Ontario
London, Ontario, Canada, N6A 4G5
Physician's Clinical Research Inc.
Vaughan, Ontario, Canada, L4L 4Y7
Sponsors and Collaborators
Forest Laboratories
Ironwood Pharmaceuticals, Inc.
Investigators
Study Director: Anna Muslin Forest Laboratories, LLC, an Allergan Affiliate

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT02559570     History of Changes
Other Study ID Numbers: LIN-MD-62
First Posted: September 24, 2015    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Forest Laboratories:
Functional constipation in children
Linzess

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms