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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)

This study is currently recruiting participants.
Verified July 2017 by Forest Laboratories
Sponsor:
ClinicalTrials.gov Identifier:
NCT02559570
First Posted: September 24, 2015
Last Update Posted: July 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Ironwood Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Forest Laboratories
  Purpose

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 Intervention 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
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • 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:
  • 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).

  • 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).

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

Estimated Enrollment: 160
Actual Study Start Date: November 30, 2015
Estimated Study Completion Date: March 31, 2018
Estimated Primary Completion Date: March 31, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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:

    1. History of retentive posturing or excessive volitional stool retention
    2. History of painful or hard bowel movements (BMs)
    3. Presence of a large fecal mass in the rectum
    4. 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 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
  Contacts and Locations
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


Contacts
Contact: Clinical Trial Registries Team 877-277-8566 IR-CTRegistration@allergan.com

  Hide Study Locations
Locations
United States, Arkansas
HealthStar Research, LLC Recruiting
Hot Springs, Arkansas, United States, 71913
United States, California
Advanced Research Center Recruiting
Anaheim, California, United States, 92805
WCCT Global, LLC Recruiting
Costa Mesa, California, United States, 92626
ACTCA, Inc Active, not recruiting
Los Angeles, California, United States, 90017
Children's Hospital Los Angeles Not yet recruiting
Los Angeles, California, United States, 90027
Orange County Research Institute Recruiting
Ontario, California, United States, 91762
Center for Clinical Trials, LLC Recruiting
Paramount, California, United States, 90723
UCSD Rady Children's Hospital Not yet recruiting
San Diego, California, United States, 92123
Ventura Clinical Trials Active, not recruiting
Ventura, California, United States, 93003
United States, Colorado
Forest Investigative Site Withdrawn
Thornton, Colorado, United States, 80233
United States, Florida
Nova Southeastern University Recruiting
Fort Lauderdale, Florida, United States, 33328
Homestead Research Institute Active, not recruiting
Homestead, Florida, United States, 33030
Advanced Medical Research Center Recruiting
Miami, Florida, United States, 33135
SCORE Physician Alliance, LLC Active, not recruiting
Saint Petersburg, Florida, United States, 33710
United States, Georgia
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 Recruiting
Wichita, Kansas, United States, 67205
United States, Kentucky
Kentucky Pediatric/ Adult Research Recruiting
Bardstown, Kentucky, United States, 40004
Michael W. Simon, MD, PSC Recruiting
Nicholasville, Kentucky, United States, 40356
United States, Louisiana
Willis-Knighton Physician Network Recruiting
Shreveport, Louisiana, United States, 71118
United States, Maryland
University of Maryland Children's Hospital Not yet recruiting
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Massachusetts General Hospital Not yet recruiting
Boston, Massachusetts, United States, 02114
United States, Minnesota
University Of Minnesota Not yet recruiting
Minneapolis, Minnesota, United States, 55455
United States, Mississippi
GI Associates and Endoscopy Center Recruiting
Jackson, Mississippi, United States, 39202
United States, Missouri
Craig A. Speigel, MD Recruiting
Bridgeton, Missouri, United States, 63044
United States, Nebraska
Boys Town National Research Hospital Recruiting
Boys Town, Nebraska, United States, 68010
Midwest Children Health Research Institute Recruiting
Lincoln, Nebraska, United States, 68505
Midwest Children Health Research Institute 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 Recruiting
Newark, New Jersey, United States, 07103
United States, New York
Columbia University Medical Center and Morgan Stanley Not yet recruiting
New York, New York, United States, 10032
Novel Research of New York, LLC Recruiting
The Bronx, New York, United States, 10461
United States, North Carolina
Asheboro Research Associates Active, not recruiting
Asheboro, North Carolina, United States, 27203
Capital Pediatrics and Adolescent Center PLLC Recruiting
Raleigh, North Carolina, United States, 27609
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Dayton Clinical Research Active, not recruiting
Dayton, Ohio, United States, 45406
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
Pediatric Care Specialists Active, not recruiting
Johnstown, Pennsylvania, United States, 15904
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
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 Pediatrics Associates Recruiting
Mount Pleasant, South Carolina, United States, 26464
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
Southwest Children's Research Associates, P.A. Recruiting
San Antonio, Texas, United States, 78229
ClinPoint Trials Recruiting
Waxahachie, Texas, United States, 75165
United States, Utah
Foothill Family Clinic South / J. Lewis Research, Inc. Recruiting
Salt Lake City, Utah, United States, 84121
United States, Virginia
Virginia Tech Carilion School of Medicine Pediatric Recruiting
Roanoke, Virginia, United States, 24013
Forest Investigative Site Withdrawn
Vienna, Virginia, United States, 22180
United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
United States, Wisconsin
Forest Investigative Withdrawn
Milwaukee, Wisconsin, United States, 53226
Canada, Alberta
Stollery Children's Hospital Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Canada, Ontario
Children's Hospital of Western Ontario Not yet recruiting
London, Ontario, Canada, N6A 4G5
Sponsors and Collaborators
Forest Laboratories
Ironwood Pharmaceuticals, Inc.
Investigators
Study Director: Anna Muslin Forest Laboratories, LLC, an Allergan Affiliate
  More Information

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT02559570     History of Changes
Other Study ID Numbers: LIN-MD-62
First Submitted: September 23, 2015
First Posted: September 24, 2015
Last Update Posted: July 21, 2017
Last Verified: July 2017

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