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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 (LIN-MD-63)

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ClinicalTrials.gov Identifier: NCT02559817
Recruitment Status : Recruiting
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 Irritable Bowel syndrome with Constipation (IBS-C), in children age 7-17 years.

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.


Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome With Constipation 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)
Estimated Enrollment : 260 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, A Multicenter, Randomized, Double-blind, Placebo-controlled Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children Ages 7-17 Years, With Irritable Bowel Syndrome With Constipation (IBS-C) (ie, Fulfill Rome III Criteria for Child/Adolescent IBS and Fulfill Modified Rome III Criteria for Child/Adolescent Functional Constipation
Actual Study Start Date : November 1, 2015
Estimated Primary Completion Date : October 18, 2020
Estimated Study Completion Date : October 18, 2020

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: 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

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: 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

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: 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

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: 290 micrograms 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 or placebo solid oral capsule in children 7-11 years of age

Placebo solid oral capsule in children 12-17 years of age

Drug: Matching Placebo
Other Name: Linzess




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 ]
    The numerator of the SBM rate (SBMs/week) during the Treatment Period will be derived based on the total number of SBMs a patient reported during the treatment period


Secondary Outcome Measures :
  1. Change from baseline in 4-week abdominal pain daytime symptoms based on evening assessment of abdominal pain symptoms [ Time Frame: Baseline to week 4 ]
    Patients are asked to rate their abdominal pain from the time the patient wakes up until bedtime as part of the evening assessment. A 5-point rating scale is derived from the patient's responses, with 0 being no abdominal pain and 4 being a lot of abdominal pain.

  2. 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).

  3. 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).

  4. Change from baseline in 4-week abdominal bloating daytime symptoms based on evening assessment [ Time Frame: Baseline to week 4 ]
    Patients are asked to rate their abdominal bloating from the time the patient wakes up until bedtime as part of the evening assessment, and a 5-point rating scale is derived from the patient's responses, with 0 being no abdominal bloating and 4 being a lot of abdominal bloating.

  5. Change from baseline in 4-week overall complete spontaneous bowel movement (CSBM) frequency rate (CSBMs per Week) [ Time Frame: Baseline to week 4 ]
    A patient's 4-week overall CSBM frequency rate will be the CSBM rate (CSBMs/week) calculated over the 4-week Treatment Period. The numerator of the CSBM rate (CSBMs/week) during the 4-week Treatment Period will be derived based on the total number of CSBMs a patient reported during the treatment period.



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Ages Eligible for Study:   7 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 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:

  • 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 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

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): NCT02559817


Contacts
Contact: Clincial Trials Registry Team 877-277-8566 IR-CTRegistration@allergan.com

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Locations
United States, Arkansas
HealthStar Research, LLC Recruiting
Hot Springs, Arkansas, United States, 71913
Applied Research Center of Arkansas Recruiting
Little Rock, Arkansas, United States, 72212
United States, California
Advanced Research Center - Site 069 Recruiting
Anaheim, California, United States, 92805
Kindred Medical Institute for Clinical Trials, LLC Recruiting
Corona, California, United States, 92879
WCCT Global, LLC Active, not recruiting
Costa Mesa, California, United States, 92626
Ark Clinical Research Recruiting
Long Beach, California, United States, 90806
ACTCA, Inc Active, not recruiting
Los Angeles, California, United States, 90017
Children's Hospital Los Angeles Active, not recruiting
Los Angeles, California, United States, 90027
Center for Clinical Trials, LLC Recruiting
Paramount, California, United States, 90723
UCSD Rady Children's Hospital Recruiting
San Diego, California, United States, 92123
University of California at San Francisco Recruiting
San Francisco, California, United States, 94143
Ventura Clinical Trials Active, not recruiting
Ventura, California, United States, 93003
United States, Colorado
Colorado Springs Health Partners, HCP-Clinical Research, LLC Recruiting
Colorado Springs, Colorado, United States, 80922
United States, Florida
Homestead Research Institute Active, not recruiting
Homestead, Florida, United States, 33030
RM Medical Research Recruiting
Homestead, Florida, United States, 33030
Advanced Medical Research Center Active, not recruiting
Miami, Florida, United States, 33135
United States, Georgia
Children's Center for Digestive Health Care LLC Recruiting
Atlanta, Georgia, United States, 30342
Sleepcare Clinical Research Institute Recruiting
Stockbridge, Georgia, United States, 30281
United States, Illinois
Methodist Medical Center Recruiting
Peoria, Illinois, United States, 61602
United States, Indiana
Riley Hospital for Children at Indiana University Health Recruiting
Indianapolis, Indiana, United States, 46202
United States, Kansas
Heartland Research Associates, LLC Active, not recruiting
Wichita, Kansas, United States, 67205
United States, Kentucky
Kentucky Pediatric/ Adult Research Active, not recruiting
Bardstown, Kentucky, United States, 40004
United States, Louisiana
Willis-Knighton Physician Network Recruiting
Shreveport, Louisiana, United States, 71118
United States, Maryland
University of Maryland Children's Hospital Recruiting
Baltimore, Maryland, United States, 21201
Certified Research Consultants Virgo/Carter Pediatrics Recruiting
Silver Spring, Maryland, United States, 20910
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
United States, Minnesota
University Of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55454
United States, Mississippi
GI Associates and Endoscopy Center Recruiting
Jackson, Mississippi, United States, 39202
United States, Missouri
Children's Mercy Hospital Recruiting
Kansas City, Missouri, United States, 64108
United States, Nebraska
Boys Town National Research Hospital Active, not recruiting
Boys Town, Nebraska, United States, 68010
Midwest Children Health Research Institute Active, not recruiting
Lincoln, Nebraska, United States, 68505
Midwest Children Health Research Institute Active, not recruiting
Lincoln, Nebraska, United States, 68516
United States, New Jersey
Goryeb Children's Hospital Recruiting
Morristown, New Jersey, United States, 07962
New Jersey Medical School, Rutgers University Active, not recruiting
Newark, New Jersey, United States, 07103
United States, New York
Novel Research of New York, LLC Active, not recruiting
Bronx, New York, United States, 10461
Columbia University Medical Center and Morgan Stanley Children's Hospital of New York Recruiting
New York, New York, United States, 10032
United States, North Carolina
Asheboro Research Associates - Site 022 Active, not recruiting
Asheboro, North Carolina, United States, 27203
University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Capital Pediatrics and Adolescent Center PLLC Recruiting
Raleigh, North Carolina, United States, 27609
United States, Ohio
Cincinnati Children's Hospital Medical Center Active, not recruiting
Cincinnati, Ohio, United States, 45229
Ohio Pediatric Research Association Recruiting
Dayton, Ohio, United States, 45414
United States, Oklahoma
IPS Research Company Recruiting
Oklahoma City, Oklahoma, United States, 73103
United States, Pennsylvania
St. Christopher's Hospital for Children Recruiting
Philadelphia, Pennsylvania, United States, 19134
Children's Hospital of Pittsburgh of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Preferred Primary Care Physicians, Inc. Recruiting
Pittsburgh, Pennsylvania, United States, 15236
Frontier Clinical Research, LLC Recruiting
Scottdale, Pennsylvania, United States, 15683
Montgomery Medical Inc. Recruiting
Smithfield, Pennsylvania, United States, 15478
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
United States, South Carolina
Coastal Pediatric Research Recruiting
Charleston, South Carolina, United States, 29414
Coastal Pediatrics Associates Recruiting
Mount Pleasant, South Carolina, United States, 29464
United States, Texas
Texas Children's Hospital/Baylor College Medicine Recruiting
Houston, Texas, United States, 77030
Houston Clinical Research Associates Recruiting
Houston, Texas, United States, 77090
Sun Research Institute Recruiting
San Antonio, Texas, United States, 78215
ClinPoint Trials Recruiting
Waxahachie, Texas, United States, 75165
United States, Virginia
Pediatric Specialists of Virginia Recruiting
Fairfax, Virginia, United States, 22031
Children's Hospital of The King's Daughters Active, not recruiting
Norfolk, Virginia, United States, 23507
Virginia Tech Carilion School of Medicine Pediatric Gastroenterology Recruiting
Roanoke, Virginia, United States, 24013
United States, Washington
Seattle Children's Hospital Active, not recruiting
Seattle, Washington, United States, 98105
MultiCare Institute for Research and Innovation Recruiting
Tacoma, Washington, United States, 98405
Canada, Alberta
Stollery Children's Hospital Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Canada, Ontario
Children's Hospital of Western Ontario Recruiting
London, Ontario, Canada, N6A 4G5
Physician's Clinical Research Inc. Recruiting
Vaughan, Ontario, Canada, L4L 4Y7
Sponsors and Collaborators
Forest Laboratories
Ironwood Pharmaceuticals, Inc.
Investigators
Study Chair: Anna Muslin Forest Laboratories, LLC, an Allergan Affiliate

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT02559817     History of Changes
Other Study ID Numbers: LIN-MD-63
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:
Irritable Bowel Syndrome with Constipation in children
Linzess

Additional relevant MeSH terms:
Syndrome
Constipation
Irritable Bowel Syndrome
Disease
Pathologic Processes
Signs and Symptoms, Digestive
Signs and Symptoms
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases