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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)

Primary Purpose

Functional Constipation in Children Ages 6-17 Years

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Placebo

LIN Dose A

LIN Dose B

LIN Dose C

LIN 145 µg

About this trial

This is an interventional treatment trial for Functional Constipation in Children Ages 6-17 Years focused on measuring Functional constipation in children, LINZESS

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Participant weighs at least 18 kg (kilograms) (39.7 lbs)
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:

Participant 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 participant 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
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

Sites / Locations

HealthStar Research, LLC
Applied Research Center of Arkansas
Advanced Research Center
Kindred Medical Institute for Clinical Trials, LLC
WCCT Global, LLC
Ark Clinical Research
ACTCA, Inc
Children's Hospital Los Angeles
Orange County Research Institute
Center for Clinical Trials, LLC
UCSD Rady Children's Hospital
University of California at San Francisco
Ventura Clinical Trials
Colorado Springs Health Partners, HCP-Clinical Research, LLC
Nova Southeastern University
Homestead Research Institute
RM Medical Research
Advanced Medical Research Center
SCORE Physician Alliance, LLC
Children's Center for Digestive Health Care LLC
Sleepcare Clinical Research Institute
Riley Hospital for Children at Indiana University Health
Heartland Research Associates, LLC
Kentucky Pediatric/ Adult Research
Kosair Children's Hospital - Pediatric Clinical Research Unit
Michael W. Simon, MD, PSC
Willis-Knighton Physician Network
University of Maryland Children's Hospital
Massachusetts General Hospital
University Of Minnesota
GI Associates and Endoscopy Center
Craig A. Speigel, MD
Midwest Children Health Research Institute
Midwest Children Health Research Institute
Goryeb Children's Hospital
Columbia University Medical Center and Morgan Stanley
Asheboro Research Associates
University of North Carolina at Chapel Hill
Capital Pediatrics and Adolescent Center PLLC
Ohio Pediatric Research Association
IPS Research Company
Pediatric Care Specialists
St. Christopher's Hospital for Children
Children's Hospital of Pittsburgh of UPMC
Preferred Primary Care Physicians, Inc.
Frontier Clinical Research, LLC
Montgomery Medical Inc.
Rhode Island Hospital
Coastal Pediatric Research
Coastal Pediatrics Associates
Cook Children's Medical Center
Texas Children's Hospital/Baylor College Medicine
Houston Clinical Research Associates
Sun Research Institute
Southwest Children's Research Associates, P.A.
ClinPoint Trials
Foothill Family Clinic South / J. Lewis Research, Inc.
Pediatric Specialists of Virginia
Virginia Tech Carilion School of Medicine Pediatric
Seattle Children's Hospital
Stollery Children's Hospital
Children's Hospital of Western Ontario

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

LIN Dose A (9 ug or 18 ug)

LIN Dose B (18 ug or 36 ug)

LIN Dose C (36 ug or 72 ug)

LIN 145 µg

Arm Description

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Change From Baseline (CFB) in 4-week Overall Spontaneous Bowel Movement (SBM) Frequency Rate During the Treatment Period

SBM was defined as a BM that occurred in the absence of laxative, suppository, or enema use on the calendar day of the BM or the calendar day before the BM. SBM rate was defined as SBMs/week during the 4-week Treatment period. Participants recorded the occurrence of BMs and use of rescue medication, morning and evening, daily in an eDiary since pretreatment period. The SBM frequency rate (SBMs/week) during the analysis period for each participant were calculated as [(total number of SBMs in the analysis period/number of days in the analysis period)*7]. Baseline value was based on values collected 14 days before randomization up to randomization. Change from Baseline was calculated as the SBM frequency rate during the 4-week treatment period - SBM frequency rate at baseline. A positive change from Baseline indicates improvement. Least squares mean (LSM) and standard error (SE) were calculated using analysis of covariance (ANCOVA) method.

Secondary Outcome Measures

Change From Baseline (CFB) in 4-week Daytime Abdominal Pain

The abdominal pain score was measured using 5-point scale. Participants answered the questions, How much did your tummy hurt as: 0=none, 1=a tiny bit, 2=a little, 3=some, and 4=a lot. The 4-week daytime abdominal pain was calculated as the average of nonmissing scores in evening eDiary during the Treatment Period with higher value indicating greater symptom severity. Baseline value was the average of non-missing values collected 14 days before randomization. Change from Baseline was calculated as the daytime abdominal pain score during the 4-week treatment period (i.e. average of non-missing daytime scores during 4-week treatment period) - daytime abdominal pain score at baseline. A negative change from Baseline indicates improvement. LSM and SE were calculated using ANCOVA method.

Change From Baseline (CFB) in 4-week Stool Consistency

Participants used 7-point pediatric Bristol Stool Form (p-BSFS) scale to rate stool consistency for each BM in morning and evening eDiary where 1=small hard lumps or balls like pebbles,2=fat sausage shape but lumpy and hard,3=a sausage but with cracks on it,4=sausage or snake, smooth and soft,5=chicken nuggets, soft smooth blobs,6=oatmeal, fluffy mushy pieces,7=milkshake, watery. Scores in 4-week treatment period were calculated by 2 approaches-1) following derivation similar in earlier adult studies, mean of participants non-missing, SBM associated p-BSFS scores during 4-week treatment period (adult derivation),2) observed weighted average of daily p-BSFS scores during that period. Daily p-BSFS score was average of non-missing morning and/or evening assessments of p-BSFS score from SBMs reported by participants on that specific day. Baseline value was based on values collected 14 days before randomization up to randomization. LSM and SE were calculated using ANCOVA method.

Change From Baseline (CFB) in 4-week of Severity of Straining

Severity of straining was scored on 5-point scale for question-When you pooped, how hard did you push? The score ranges from 0= not hard at all,1= I pushed a tiny bit hard,2= I pushed a little hard,3= I pushed hard,4= I pushed very hard with higher scores indicating more severe straining. Participants recorded degree of straining for each BM in morning and evening eDiary. Data was derived as adult derivation and weighted average. Scores during 4-week treatment period were calculated following two approaches - (1) following derivation similar in earlier adult studies, as mean of participant's non-missing, SBM associated straining scores during 4-week treatment period (adult derivation) and (2) as observed weighted average of daily straining scores during that period. Daily straining score was the average of non-missing morning and/or evening assessments of straining score from the SBMs reported by the participants on that specific day. LSM and SE were calculated using ANCOVA method.

Change From Baseline (CFB) in 4-week Abdominal Bloating Daytime Symptoms Based on Evening Assessment

Participants recorded their assessment of abdominal bloating in the evening eDiary. Participants answered the question: How big and full did your tummy feel? on a scale, where: 0=none, 1=a tiny bit, 2=a little, 3=medium or 4=very, with a higher score indicating more severe bloating. Baseline value was the average of values collected 14 days before randomization. The 4-week daytime abdominal bloating symptoms were calculated as the average of non-missing scores reported in the evening eDiary during the treatment period. Change from Baseline was calculated as the 4-week daytime abdominal bloating score during the treatment period - daytime abdominal bloating score at baseline. A negative change from Baseline indicates improvement. LSM and SE were calculated using ANCOVA method.

Change From Baseline (CFB) in 4-week Overall Complete Spontaneous Bowel Movement Frequency Rate (CSBM/Week) During the Treatment Period

SBM was defined as a BM that occurred in the absence of laxative, suppository, or enema use on the calendar day of the BM or the calendar day before the BM. A CSBM was an SBM that was associated with a sense of complete evacuation. Participants recorded their assessment of the sensation of incomplete evacuation for each BM in the morning and evening eDiary. The 4-week overall CSBM frequency rate was calculated as [total number of CSBMs in the analysis period/number of days in the analysis period]*7). Baseline value was based on values collected 14 days before randomization and up to randomization. Change from Baseline was calculated as the CSBM frequency rate during the 4-week treatment period - CSBM frequency rate at baseline. A positive change from Baseline indicates improvement. LSM and SE were calculated using ANCOVA method.

Change From Baseline in 4-week Fecal Incontinence Daytime Symptoms Based on Evening Assessment

Participants recorded the presence of incontinence episodes in daytime daily since pre-treatment period (14-day prior to randomization) in the evening eDiary for participants randomized following protocol amendment #3. The 4-week daytime fecal incontinence was calculated as the mean of non-missing participant scores reported in the evening eDiary during the Treatment Period. Baseline value was the average of values collected 14 days before randomization. Change from Baseline was calculated as the 4-week fecal incontinence daytime symptoms during the treatment period - fecal incontinence daytime symptoms at baseline. A negative change from Baseline indicates improvement. No data is reported for LIN 145 μg as it was an exploratory arm group.

Full Information

NCT ID

NCT02559570

First Posted

September 23, 2015

Last Updated

June 7, 2019

Sponsor

Forest Laboratories

Collaborators

Ironwood Pharmaceuticals, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02559570

Brief Title

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)

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)

Study Type

Interventional

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Completed

Study Start Date

November 3, 2015 (Actual)

Primary Completion Date

April 20, 2018 (Actual)

Study Completion Date

May 29, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Forest Laboratories

Collaborators

Ironwood Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study was to evaluate dose response of 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. Participants age 6-11 years will receive oral liquid formulation and participants 12-17 years 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Functional Constipation in Children Ages 6-17 Years

Keywords

Functional constipation in children, LINZESS

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

173 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Arm Title

LIN Dose A (9 ug or 18 ug)

Arm Type

Experimental

Arm Description

Arm Title

LIN Dose B (18 ug or 36 ug)

Arm Type

Experimental

Arm Description

Arm Title

LIN Dose C (36 ug or 72 ug)

Arm Type

Experimental

Arm Description

Arm Title

LIN 145 µg

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Participants received matching placebo LIN liquid solution or solid capsules, orally, 30 minutes before evening meal, once daily for 4 weeks.

Intervention Type

Drug

Intervention Name(s)

LIN Dose A

Other Intervention Name(s)

LINZESS

Intervention Description

Participants received LIN 9 or 18 ug liquid solution or solid capsules, orally, 30 minutes before evening meal, once daily for 4 weeks.

Intervention Type

Drug

Intervention Name(s)

LIN Dose B

Other Intervention Name(s)

LINZESS

Intervention Description

Participants received LIN 18 or 36 ug liquid solution or solid capsules, orally, 30 minutes before evening meal, once daily for 4 weeks.

Intervention Type

Drug

Intervention Name(s)

LIN Dose C

Other Intervention Name(s)

LINZESS

Intervention Description

Participants received LIN 36 or 72 ug liquid solution or solid capsules, orally, 30 minutes before evening meal, once daily for 4 weeks.

Intervention Type

Drug

Intervention Name(s)

LIN 145 µg

Other Intervention Name(s)

LINZESS

Intervention Description

Participants received LIN 145 µg, liquid solution or solid capsules, 30 minutes before evening meal, once daily for 4 weeks.

Primary Outcome Measure Information:

Title

Change From Baseline (CFB) in 4-week Overall Spontaneous Bowel Movement (SBM) Frequency Rate During the Treatment Period

Description

Time Frame

Baseline (14-day prior to randomization and up to randomization) to Week 4

Secondary Outcome Measure Information:

Title

Change From Baseline (CFB) in 4-week Daytime Abdominal Pain

Description

Time Frame

Baseline (14-day prior to randomization) to Week 4

Title

Change From Baseline (CFB) in 4-week Stool Consistency

Description

Time Frame

Baseline (14-day prior to randomization and up to randomization) to Week 4

Title

Change From Baseline (CFB) in 4-week of Severity of Straining

Description

Time Frame

Baseline (14-day prior to randomization and up to randomization) to Week 4

Title

Change From Baseline (CFB) in 4-week Abdominal Bloating Daytime Symptoms Based on Evening Assessment

Description

Time Frame

Baseline (14-day prior to randomization) to Week 4

Title

Change From Baseline (CFB) in 4-week Overall Complete Spontaneous Bowel Movement Frequency Rate (CSBM/Week) During the Treatment Period

Description

Time Frame

Baseline (14-day prior to randomization and up to randomization) to Week 4

Title

Change From Baseline in 4-week Fecal Incontinence Daytime Symptoms Based on Evening Assessment

Description

Time Frame

Baseline (14-day prior to randomization) to Week 4

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Participant weighs at least 18 kg (kilograms) (39.7 lbs) 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: Participant 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 participant 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Taryn Weissman

Organizational Affiliation

Allergan, LLC

Official's Role

Study Director

Facility Information:

Facility Name

HealthStar Research, LLC

City

Hot Springs

State/Province

Arkansas

ZIP/Postal Code

71913

Country

United States

Facility Name

Applied Research Center of Arkansas

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72212

Country

United States

Facility Name

Advanced Research Center

City

Anaheim

State/Province

California

ZIP/Postal Code

92805

Country

United States

Facility Name

Kindred Medical Institute for Clinical Trials, LLC

City

Corona

State/Province

California

ZIP/Postal Code

92879

Country

United States

Facility Name

WCCT Global, LLC

City

Costa Mesa

State/Province

California

ZIP/Postal Code

92626

Country

United States

Facility Name

Ark Clinical Research

City

Long Beach

State/Province

California

ZIP/Postal Code

90806

Country

United States

Facility Name

ACTCA, Inc

City

Los Angeles

State/Province

California

ZIP/Postal Code

90017

Country

United States

Facility Name

Children's Hospital Los Angeles

City

Los Angeles

State/Province

California

ZIP/Postal Code

90017

Country

United States

Facility Name

Orange County Research Institute

City

Ontario

State/Province

California

ZIP/Postal Code

91762

Country

United States

Facility Name

Center for Clinical Trials, LLC

City

Paramount

State/Province

California

ZIP/Postal Code

90723

Country

United States

Facility Name

UCSD Rady Children's Hospital

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

Facility Name

University of California at San Francisco

City

San Francisco

State/Province

California

ZIP/Postal Code

94143

Country

United States

Facility Name

Ventura Clinical Trials

City

Ventura

State/Province

California

ZIP/Postal Code

93003

Country

United States

Facility Name

Colorado Springs Health Partners, HCP-Clinical Research, LLC

City

Colorado Springs

State/Province

Colorado

ZIP/Postal Code

80922

Country

United States

Facility Name

Nova Southeastern University

City

Fort Lauderdale

State/Province

Florida

ZIP/Postal Code

33314

Country

United States

Facility Name

Homestead Research Institute

City

Homestead

State/Province

Florida

ZIP/Postal Code

33030

Country

United States

Facility Name

RM Medical Research

City

Homestead

State/Province

Florida

ZIP/Postal Code

33030

Country

United States

Facility Name

Advanced Medical Research Center

City

Miami

State/Province

Florida

ZIP/Postal Code

33135

Country

United States

Facility Name

SCORE Physician Alliance, LLC

City

Saint Petersburg

State/Province

Florida

ZIP/Postal Code

33710

Country

United States

Facility Name

Children's Center for Digestive Health Care LLC

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30342

Country

United States

Facility Name

Sleepcare Clinical Research Institute

City

Stockbridge

State/Province

Georgia

ZIP/Postal Code

30281

Country

United States

Facility Name

Riley Hospital for Children at Indiana University Health

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Facility Name

Heartland Research Associates, LLC

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67205

Country

United States

Facility Name

Kentucky Pediatric/ Adult Research

City

Bardstown

State/Province

Kentucky

ZIP/Postal Code

40004

Country

United States

Facility Name

Kosair Children's Hospital - Pediatric Clinical Research Unit

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40202

Country

United States

Facility Name

Michael W. Simon, MD, PSC

City

Nicholasville

State/Province

Kentucky

ZIP/Postal Code

40356

Country

United States

Facility Name

Willis-Knighton Physician Network

City

Shreveport

State/Province

Louisiana

ZIP/Postal Code

71118

Country

United States

Facility Name

University of Maryland Children's Hospital

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21201

Country

United States

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

University Of Minnesota

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55455

Country

United States

Facility Name

GI Associates and Endoscopy Center

City

Jackson

State/Province

Mississippi

ZIP/Postal Code

39232

Country

United States

Facility Name

Craig A. Speigel, MD

City

Bridgeton

State/Province

Missouri

ZIP/Postal Code

63044

Country

United States

Facility Name

Midwest Children Health Research Institute

City

Lincoln

State/Province

Nebraska

ZIP/Postal Code

68505

Country

United States

Facility Name

Midwest Children Health Research Institute

City

Lincoln

State/Province

Nebraska

ZIP/Postal Code

68516

Country

United States

Facility Name

Goryeb Children's Hospital

City

Morristown

State/Province

New Jersey

ZIP/Postal Code

07962

Country

United States

Facility Name

Columbia University Medical Center and Morgan Stanley

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Facility Name

Asheboro Research Associates

City

Asheboro

State/Province

North Carolina

ZIP/Postal Code

27203

Country

United States

Facility Name

University of North Carolina at Chapel Hill

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599

Country

United States

Facility Name

Capital Pediatrics and Adolescent Center PLLC

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27609

Country

United States

Facility Name

Ohio Pediatric Research Association

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45414

Country

United States

Facility Name

IPS Research Company

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73103

Country

United States

Facility Name

Pediatric Care Specialists

City

Johnstown

State/Province

Pennsylvania

ZIP/Postal Code

15904

Country

United States

Facility Name

St. Christopher's Hospital for Children

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19134

Country

United States

Facility Name

Children's Hospital of Pittsburgh of UPMC

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15224

Country

United States

Facility Name

Preferred Primary Care Physicians, Inc.

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15236

Country

United States

Facility Name

Frontier Clinical Research, LLC

City

Scottdale

State/Province

Pennsylvania

ZIP/Postal Code

15683

Country

United States

Facility Name

Montgomery Medical Inc.

City

Smithfield

State/Province

Pennsylvania

ZIP/Postal Code

15478

Country

United States

Facility Name

Rhode Island Hospital

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02903

Country

United States

Facility Name

Coastal Pediatric Research

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29414

Country

United States

Facility Name

Coastal Pediatrics Associates

City

Mount Pleasant

State/Province

South Carolina

ZIP/Postal Code

29464

Country

United States

Facility Name

Cook Children's Medical Center

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76104

Country

United States

Facility Name

Texas Children's Hospital/Baylor College Medicine

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Houston Clinical Research Associates

City

Houston

State/Province

Texas

ZIP/Postal Code

77090

Country

United States

Facility Name

Sun Research Institute

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78215

Country

United States

Facility Name

Southwest Children's Research Associates, P.A.

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

ClinPoint Trials

City

Waxahachie

State/Province

Texas

ZIP/Postal Code

75165

Country

United States

Facility Name

Foothill Family Clinic South / J. Lewis Research, Inc.

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84121

Country

United States

Facility Name

Pediatric Specialists of Virginia

City

Fairfax

State/Province

Virginia

ZIP/Postal Code

22031

Country

United States

Facility Name

Virginia Tech Carilion School of Medicine Pediatric

City

Roanoke

State/Province

Virginia

ZIP/Postal Code

24013

Country

United States

Facility Name

Seattle Children's Hospital

City

Seattle

State/Province

Washington

ZIP/Postal Code

98105

Country

United States

Facility Name

Stollery Children's Hospital

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 2B7

Country

Canada

Facility Name

Children's Hospital of Western Ontario

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 4G5

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

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)

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