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AzTrials

Functional ConstipationPhase 3NCT04026113

Linaclotide Safety and Efficacy in Pediatric Participants, 6 to 17 Years of Age, With Irritable Bowel Syndrome With Constipation (IBS-C) or Functional Constipation (FC)

A Phase 3 study testing Linaclotide in people with Functional Constipation and Irritable Bowel Syndrome With Constipation, run by AbbVie at 115 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The objective of LIN-MD-64 is to evaluate the safety and efficacy of 12 weeks of linaclotide therapy (72 μg daily) in comparison with placebo in pediatric participants, 6 to 17 years of age, who fulfill modified Rome III Criteria for child/adolescent FC. Read more about this study

Who is it for?
Ages 6 to 17 years
What is being tested?
Linaclotide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
438 participants
Where
115 sitesin 14 countries
Study dates
1 Oct 2019to 29 May 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Male and female participants must be ages 6 to 17 years (FC participants) or ages 7 to 17 years (IBS-C participants) (inclusive) at the time the participant provides assent for the study and parent/guardian/legally authorized representative (LAR) has provided signed consent;
  • Participant weighs ≥18 kg at the time the participant provides assent and the parent/guardian/LAR has provided signed consent;
  • Participants who meet the 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, participant meets one or more of the following criteria at least once per week for at least 2 months before the screening visit:
  • History of retentive posturing or excessive volitional stool retention; b. History of painful or hard BMs; c. History of large diameter stools that may obstruct the toilet; d. Presence of a large fecal mass in the rectum; e. At least 1 episode of fecal incontinence per week
  • For IBS-C participants only: Participant meets Rome III criteria for child/adolescent IBS: At least once per week for at least 2 months before the Screening Visit, the participant 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:
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  • Improvement with defecation;
  • Onset associated with a change in frequency of stool;
  • Onset associated with a change in form (appearance) of stool;
  • For IBS-C participants only: Participant has an average daytime abdominal pain score of ≥ 1 (at least "a tiny bit") during the 14 days before Visit 3;
  • Participant is willing to discontinue any laxatives used before the Preintervention Visit in favor of the protocol- permitted rescue medicine;
  • Participant has an average of fewer than 3 SBMs per week during the 14 days before the randomization day and up to the randomization (including the morning eDiary assessments reported before administration of first dose of double-blind study intervention on the randomization day). 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 parent/guardian/LAR or caregiver is compliant with eDiary requirements by completing both the morning and evening assessments for 10 out of the 14 days immediately preceding the Randomization Visit;
  • Female participants of childbearing potential must have a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test at the Randomization Visit prior to dosing;
  • Female participants who have had their first menstrual period and are sexually active must agree to use a reliable form of contraception;
  • Participant must provide written or verbal informed assent and the parent/guardian/LAR and caregiver must provide written informed consent before the initiation of any study-specific procedures;
  • Participant is able to read and/or understand the assessments in the eDiary device. If the participant is 6 to 11 years of age (FC participants) or 7 to 11 years of age (IBS-C participants) and does not meet this criterion, the interviewer-administered version of the eDiary must be used and the parent/guardian/LAR or caregiver who will be administering the interviewer-administered version of the eDiary must undergo training;
  • Participant must have acquired toilet training skills.

Who cannot join

  • For FC participants only: Participant meets Rome III criteria for Child/Adolescent 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:
  • Improvement with defecation
  • Onset associated with a change in frequency of stool
  • 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 (including the morning eDiary assessments reported before administration of first dose of double-blind study intervention on the randomization day);
  • Participant has a history of non-retentive fecal incontinence;
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  • Participant has (a) fecal impaction at Visit 2 after failing outpatient clean-out during the Screening Period or (b) fecal impaction at Visit 3;
  • Participant has required manual disimpaction any time prior to randomization;
  • Participant currently has both unexplained and clinically significant alarm symptoms (lower GI bleeding [rectal bleeding or heme-positive stool], iron-deficiency anemia, or any unexplained anemia, or weight loss) and systemic signs of infection or colitis, or any neoplastic process;
  • Participant has clinically significant findings on a physical examination, vital sign assessment, electrocardiogram (ECG), or clinical laboratory test as determined by the investigator based on consideration of whether the finding could represent a safety concern or a condition that would be exclusionary, could prevent the participant from performing any protocol assessments, or could confound study assessments;
  • Participant has a history of drug or alcohol abuse;
  • Participant has any of the following conditions:
  • Celiac disease, or positive serological test for celiac disease and the condition has not been ruled out by endoscopic biopsy;
  • Cystic fibrosis;
  • Hypothyroidism that is untreated or treated with thyroid hormone at a dose that has not been stable for at least 3 months prior to the Screening Visit;
  • Down's syndrome or any other chromosomal disorder;
  • Active anal fissure (Note: History of anal fissure is not an exclusion);
  • Anatomic malformations (eg, imperforate anus, anal stenosis, anterior displaced anus);
  • Intestinal nerve or muscle disorders (eg, Hirschprung disease, visceral myopathies, visceral neuropathies);
  • Neuropathic conditions (eg, spinal cord abnormalities, neurofibromatosis, tethered cord, spinal cord trauma);
  • Lead toxicity, hypercalcemia;
  • Neurodevelopmental disabilities (early-onset, chronic disorders that share the essential feature of a predominant disturbance in the acquisition of cognitive, motor, language, or social skills, which has a significant and continuing impact on the developmental progress of an individual) producing a cognitive delay that precludes comprehension and completion of the daily eDiary (Electronic handheld device) or other study-related questionnaires (Note: Participants are excluded if the person who will be completing the daily eDiary or other study-related questionnaires meets this criterion);
  • Inflammatory bowel disease;
  • Childhood functional abdominal pain syndrome;
  • Childhood functional abdominal pain;
  • Poorly treated or poorly controlled psychiatric disorders that might influence his or her ability to participate in the study;
  • Lactose intolerance that is associated with abdominal pain or discomfort and could confound the assessments in this study;
  • History of cancer other than treated basal cell carcinoma of the skin; (Note: Participants with a history of cancer are allowed provided that the malignancy has been in a complete remission for at least 5 years before the Randomization Visit. A complete remission is defined as the disappearance of all signs of cancer in response to treatment);
  • History of diabetic neuropathy.
  • Participant has an acute or chronic condition that, in the investigator's opinion, would limit the participants' ability to complete or participate in this clinical study;
  • Participant has a known or suspected mechanical bowel obstruction or pseudoobstruction;
  • Participant has a known allergy or sensitivity to the study intervention or its components or other medications in the same drug class.
  • Participant has had surgery that meets any of the following criteria:
  • Bariatric surgery for treatment of obesity, or surgery to remove a segment of the GI tract at any time before the Screening Visit;
  • Surgery of the abdomen, pelvis, or retroperitoneal structures during the 6 months before the Screening Visit;
  • An appendectomy or cholecystectomy during the 60 days before the Screening Visit;
  • Other major surgery during the 30 days before the Screening Visit;
  • Participant used a protocol-specified prohibited medicine before the start of the Preintervention Period or failed to meet the stable-dose requirements of certain medications;
  • Participant used rescue medication on the calendar day before the Randomization Visit and on the day of the Randomization Visit until randomized;
  • Participant received a study intervention during the 30 days before the Screening Visit or is planning to receive a study intervention (other than that administered during this study);
  • Participant has been randomized into any clinical study in which linaclotide was a study intervention.
  • The participant has a condition or is in a situation; which, in the investigator's opinion, may put the participant at significant risk, may confound the study results ,or may interfere significantly with the participant's participation in the study;
  • Participants who have positive urine drug screen results for cocaine, barbiturates, opiates, or cannabinoids will be excluded from study participation;
  • Female participants who are currently pregnant or nursing, or plan to become pregnant or nurse during the clinical study;
  • Participant's parent/guardian/LAR or caregiver has been directly or indirectly involved in the conduct and administration of this study as an investigator, study coordinator, or other study staff member. In addition, any participant, parent/guardian/LAR or caregiver who has a first-degree family member, significant other, or relative residing with him/her directly or indirectly who is involved in this study.

Trial locations and contacts

115 sites in 14 countries.

115 sites in 14 countries

United States79 sites

  • University of New Mexico /ID# 233011

    Albuquerque, New Mexico, 87102-4517

  • Advanced Research Center /ID# 233121

    Anaheim, California, 92805

  • Treken Primary Care /ID# 232796

    Atlanta, Georgia, 30315

  • Children's Healthcare of Atlanta - Ferry Rd /ID# 233015

    Atlanta, Georgia, 30342-1605

  • Children's Ctr Digestive, US /ID# 233070

    Atlanta, Georgia, 30342

  • Lynn Institute of Denver /ID# 233137

    Aurora, Colorado, 80012

  • Meridian Research - Baton Rouge /ID# 232954

    Baton Rouge, Louisiana, 70806-7631

  • Alliance Research Institute /ID# 232754

    Bell Gardens, California, 90201

  • Central Research Associates /ID# 233124

    Birmingham, Alabama, 35205

  • River Birch Research Alliance /ID# 233122

    Blue Ridge, Georgia, 30513

  • Private Practice - Dr. Craig Spiegel /ID# 232707

    Bridgeton, Missouri, 63044

  • Alliance Research Institute Llc /Id# 232637

    Canoga Park, California, 91304

  • Coastal Pediatric Research - West Ashley B /ID# 232816

    Charleston, South Carolina, 29414

  • Kindred Medical Institute, LLC /ID# 233042

    Corona, California, 92879

  • Oak Cliff Research Company LLC /ID# 232729

    Dallas, Texas, 75243

  • Prohealth Research Center /ID# 232805

    Doral, Florida, 33166

  • Dolphin Medical Research /ID# 232815

    Doral, Florida, 33172

  • Medclinical Research Partners LLC/ Foundation Pediatrics /ID# 232783

    East Orange, New Jersey, 07018

  • GI associates and Endoscopy Ce /ID# 233123

    Flowood, Mississippi, 39232

  • G & L Research, LLC /ID# 233139

    Foley, Alabama, 36535

  • Cook Children's Med. Center /ID# 233066

    Fort Worth, Texas, 76104

  • Office of Maria Ona /ID# 232700

    Franklin, Virginia, 23851

  • East Carolina University - Brody School of Medicine /ID# 233062

    Greenville, North Carolina, 27834

  • Valley Institute of Research /ID# 232674

    Harlingen, Texas, 78550

  • Amedica Research Institute Inc /ID# 232809

    Hialeah, Florida, 33013

  • HealthStar Research of Hot Springs PLLC /ID# 232757

    Hot Springs, Arkansas, 71913

  • Vilo Research Group Inc /ID# 233155

    Houston, Texas, 77017-2337

  • Cullen Research /ID# 232726

    Houston, Texas, 77051

  • Synergy Group US LLC /ID# 232669

    Houston, Texas, 77061

  • Pioneer Research Solutions - Houston /ID# 233006

    Houston, Texas, 77099-4307

  • Marshall University Medical Center /ID# 232952

    Huntington, West Virginia, 25701-3656

  • The Jackson Clinic, PA /ID# 232998

    Jackson, Tennessee, 38305

  • Nemours Children's Health System /ID# 233127

    Jacksonville, Florida, 32207

  • Accellacare of Knoxville /ID# 232663

    Jefferson City, Tennessee, 37760

  • Univ Kansas Med Ctr /ID# 232645

    Kansas City, Kansas, 66160

  • Michael W. Simon, MD, PSC /ID# 232966

    Lexington, Kentucky, 40517

  • Preferred Research Partners /ID# 233023

    Little Rock, Arkansas, 72211

  • Applied Research Center of Arkansas /ID# 233135

    Little Rock, Arkansas, 72212-4187

  • Elite Clinical Research /ID# 232801

    Miami, Florida, 33144

  • My Preferred Research LLC /ID# 233119

    Miami, Florida, 33155

  • South Miami Medical & Research Group Inc. /ID# 232803

    Miami, Florida, 33155

  • Valencia Medical & Research Center /ID# 232813

    Miami, Florida, 33165

  • MNGI Digestive Health, P. A. /ID# 232920

    Minneapolis, Minnesota, 55413-2195

  • Synergy Group US LLC /ID# 232670

    Missouri City, Texas, 77459

  • Advanced Research for Health Improvement /ID# 233161

    Naples, Florida, 34102-5430

  • Monroe-Carell Jr. Children's Hospital at Vanderbilt /ID# 232659

    Nashville, Tennessee, 37232

  • Columbia Univ Medical Center /ID# 233094

    New York, New York, 10032-3725

  • Health Research of Hampton Roads, Inc. (HRHR) /ID# 233056

    Newport News, Virginia, 23606

  • Alliance for Multispecialty Research LLC /ID# 232681

    Newton, Kansas, 67114

  • Univ Oklahoma HSC /ID# 233067

    Oklahoma City, Oklahoma, 73104

  • IPS Research Company /ID# 233081

    Oklahoma City, Oklahoma, 73106

  • Pediatric & Adult Research Center /ID# 232819

    Orlando, Florida, 32825

  • Nemours Children's Hospital /ID# 232919

    Orlando, Florida, 32827-7884

  • Oviedo Medical Research /ID# 232830

    Oviedo, Florida, 32765

  • Center for Clinical Trials LLC /ID# 232781

    Paramount, California, 90723

  • AIM Trials /ID# 232934

    Plano, Texas, 75093

  • David M. Headley, MD, P.A. /ID# 233153

    Port Gibson, Mississippi, 39150-2024

  • Rhode Island Hospital /ID# 233112

    Providence, Rhode Island, 02903

  • Clinical Research Partners, LLC /ID# 233026

    Richmond, Virginia, 23220-4459

  • Carilion Medical Center /ID# 232999

    Roanoke, Virginia, 24014

  • Sun Research Institute /ID# 233005

    San Antonio, Texas, 78215

  • Medical Ctr for Clin Research /ID# 233004

    San Diego, California, 92108

  • Paragon Rx Clinical Inc /ID# 232752

    Santa Ana, California, 92703

  • The Center for Clinical Trials Inc. /ID# 232755

    Saraland, Alabama, 36571

  • Frontier Clinical Research, LLC - Scottdale /ID# 233129

    Scottdale, Pennsylvania, 15683

  • Virgo Carter Pediatrics /ID# 232693

    Silver Spring, Maryland, 20910

  • Frontier Clinical Research /ID# 233116

    Smithfield, Pennsylvania, 15478

  • Chrysalis Clinical Research /ID# 232690

    St. George, Utah, 84790

  • PMG Research of Piedmont Healthcare-Statesville /ID# 233162

    Statesville, North Carolina, 28625

  • Clinical Research Institute /ID# 232833

    Stockbridge, Georgia, 30281

  • Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 232940

    Stockbridge, Georgia, 30281

  • Clinical Trials Specialist Inc /ID# 232802

    Stone Mountain, Georgia, 30083

  • Coastal Pediatric Research - Summerville /ID# 232814

    Summerville, South Carolina, 29486

  • Duplicate_Multicare Institute for Research and Innovation /ID# 233010

    Tacoma, Washington, 98405

  • The Children's Hospital at Montefiore /ID# 232638

    The Bronx, New York, 10467

  • Advantage Clinical Trials /ID# 233117

    The Bronx, New York, 10468

  • Rophe Adult and Pediatric Medicine/SKYCRNG /ID# 232800

    Union City, Georgia, 30291

  • Children's National Medical Center /ID# 232655

    Washington D.C., District of Columbia, 20010-2916

  • ClinPoint Trials /ID# 232978

    Waxahachie, Texas, 75165-1430

Other trials in United States

Israel7 sites

  • The Edith Wolfson Medical Center /ID# 233134

    Ashkelon, Southern District, 5822000

  • Duplicate_Rambam Health Care Campus Ruth Rappaport Children's Hospital /ID# 232892

    Haifa, H_efa, 31096

  • Shaare Zedek Medical Center /ID# 233092

    Jerusalem, Jerusalem, 91031

  • Hadassah Hebrew University Hospital - Ein Kerem /ID# 232865

    Jerusalem, Jerusalem, 91120

  • Schneider Children's Medical Center /ID# 233064

    Petah Tikva, Central District, 4920235

  • The Chaim Sheba Medical Center /ID# 232986

    Ramat Gan, Tel Aviv, 5265601

  • The Baruch Padeh Medical Center Poriya /ID# 232889

    Tiberias, Northern District, 15208

Other trials in Israel

Canada5 sites

  • University of Alberta Hospital /ID# 233147

    Edmonton, Alberta, T6G 2B7

  • London Health Sciences Center- University Hospital /ID# 233068

    London, Ontario, N6A 5W9

  • Duplicate_SKDS Research Inc. /ID# 233000

    Newmarket, Ontario, L3Y 5G8

  • Bluewater Clinical Research Group Inc /ID# 232772

    Sarnia, Ontario, N7T 4X3

  • Stouffville Medical Centre /ID# 232774

    Stouffville, Ontario, L4A 1H2

Other trials in Canada

Bulgaria4 sites

  • MHATSv.Ivan Rilski /ID# 232831

    Kozloduy, 3320

  • UMHAT Kanev /ID# 233102

    Ruse, Smolyan, 7002

  • Medical center 1 Sevlievo /ID# 232915

    Sevlievo, Smolyan, 5400

  • University Hospital Plovdiv /ID# 232775

    Tsentar, Plovdiv, 4001

Other trials in Bulgaria

Poland4 sites

  • Szpital Uniwersytecki Nr 1 im. dr Antoniego Jurasza /ID# 232898

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-094

  • Klinika Pediatrii Gastroenterologii Alergologii i Zywienia Dzieci GUM /ID# 232900

    Gdansk, Kuyavian-Pomeranian Voivodeship, 80-803

  • Poradnia Gastroenterologiczna /ID# 232899

    Olsztyn, Kuyavian-Pomeranian Voivodeship, 10-561

  • Korczowski Bartosz Gabinet Lekarski /ID# 232821

    Rzeszow, Kuyavian-Pomeranian Voivodeship, 35-302

Other trials in Poland

Ukraine4 sites

  • Communal Nonprofit Enterprise City Childrens Clinical Hospital 6 of Dnipro C /ID# 232863

    Dnipro, 49064

  • Kharkiv Regional Childrens Clinical Hospital Gastroent. Centre Kharkiv Natl. Me /ID# 232867

    Kharkiv, Cherkasy Oblast, 61093

  • Municipal Nonprofit Enterprise Lviv City Children's Clinical Hospital /ID# 232851

    Lviv, Cherkasy Oblast, 79059

  • Vinnytsya National Medical University Departement of Pediatrics No.1 /ID# 232890

    Vinnytsia, Cherkasy Oblast, 21029

Other trials in Ukraine

Estonia3 sites

  • Al Mare Perearstikeskus /ID# 232879

    Harjumaa, 10617

  • Merelahe Family Doctors Centre /ID# 232881

    Tallinn, Raplamaa, 10617

  • Kliiniliste Uuringute Keskus /ID# 232883

    Tartu, Raplamaa, 50410

Other trials in Estonia

Netherlands3 sites

  • Duplicate_Academisch Medisch Centrum /ID# 232895

    Amsterdam, North Holland, 1105 AZ

  • Maasstad Ziekenhuis /ID# 233003

    Rotterdam, South Holland, 3079 DZ

  • Isala /ID# 233031

    Zwolle, South Holland, 8025 AB

Other trials in Netherlands

Belgium1 site

  • Duplicate_UZ Brussel /ID# 232875

    Brussels, 1090

Other trials in Belgium

Germany1 site

  • Duplicate_Klinikum Kassel /ID# 233029

    Kassel, Hesse, 34125

Other trials in Germany

Italy1 site

  • Sant?Andrea University Hospital /ID# 232825

    Rome, 00189

Other trials in Italy

Puerto Rico1 site

  • San Juan Bautista School of Medicine /ID# 232913

    Caguas, 726

Other trials in Puerto Rico

Spain1 site

  • Instituto Hispalense Pediatria /ID# 232793

    Seville, 41014

Other trials in Spain

United Kingdom1 site

  • William Harvey Hospital /ID# 232806

    Ashford, Kent, TN24 0LZ

Other trials in United Kingdom

About this study

Official title: A Phase 3, Multicenter, Randomized, Double-blind, Parallel-group, Safety and Efficacy Study of Linaclotide in Pediatric Participants, Ages 6 to 17 Years, With Irritable Bowel Syndrome With Constipation (IBS-C) and of Linaclotide Versus Placebo in Pediatric Participants With Functional Constipation (FC)

The objective of LIN-MD-64 is to evaluate the safety and efficacy of 12 weeks of linaclotide therapy (72 μg daily) in comparison with placebo in pediatric participants, 6 to 17 years of age, who fulfill modified Rome III Criteria for child/adolescent FC. The objective of LIN-MD-64 is to evaluate the safety and efficacy of 12 weeks of linaclotide therapy (145 μg or 290 μg daily) in pediatric participants 7 to 17 years of age, who fulfill the Rome III criteria for child/adolescent IBS and modified Rome III criteria for child/adolescent FC.

Being tested
Linaclotide, Placebo
Keywords
Functional constipation in children, Irritable Bowel Syndrome with Constipation, LINZESS

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LinaclotideDrug

    Oral capsule (For participants who do not wish to take the dose as a capsule, a sprinkled dose may be prepared)

  • PlaceboDrug

    Matching placebo

Study groups in NCT04026113
Study groupRoleWhat they receive
FC Participants: PlaceboExperimentalPlacebo single dose, once daily at approximately the same time each day, 30 minutes before any meal.
Receives: Drug: Placebo
FC Participants: Linaclotide 72 μgExperimentalLinaclotide 72 μg single dose, once daily at approximately the same time each day, 30 minutes before any meal.
Receives: Drug: Linaclotide
IBS-C Participants: Linaclotide 145 μgExperimentalLinaclotide 145 μg single dose, once daily at approximately the same time each day, 30 minutes before any meal.
Receives: Drug: Linaclotide
IBS-C Participants: Linaclotide 290 μgExperimentalLinaclotide 290 μg single dose, once daily at approximately the same time each day, 30 minutes before any meal
Receives: Drug: Linaclotide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Functional Constipation (FC) Participants: Change From Baseline in 12-week SBM (Spontaneous Bowel Movement) Frequency Rate (SBMs/Week) During the Study Intervention Period

    An SBM is defined as a BM that occurs in the absence of laxative, enema, or suppository use on the calendar day of the bowel movement (BM) or the calendar day before the BM. Assessments of BM characteristics that determine occurrences of SBM (ie, BM frequency and rescue medication use) were measured by using the eDiary completed twice daily (morning and evening) on the eDiary (Electronic Diary) device.

    Measured: Baseline, up to 12 weeks

  2. Irritable Bowel Syndrome With Constipation (IBS-C) Participants: 6/12 Weeks APS (Abdominal Pain and SBM) + 2 Responder Rate

    6/12 weeks APS + 2 responder=participant who meets the weekly APS + 2 responder criteria ≥6 of the 12 weeks of the intervention period. Weekly APS +2 responder=participant who has an increase of ≥2 in the SBM weekly rate from baseline, AND a decrease of ≥30% in mean abdominal pain score from baseline, during that study intervention week. Assessments of abdominal pain and BM characteristics that determine occurrences of SBMs were measured by using an eDiary completed twice daily (AM and PM). Assessments of abdominal pain were measured using a 5-point scale where 0=none and 4=a lot. A participant's abdominal pain score=mean of the non-missing abdominal pain scores during the specified period. Responder rate=percentage of participants who were 6/12 weeks APS + 2 responders. A participant had to have ≥4 completed diary days in the analysis week to be considered a responder for that week and was otherwise considered a non-responder for that week.

    Measured: 12 Weeks

Secondary outcomes (6)

  1. Functional Constipation (FC) Participants: Change From Baseline in 12-week Stool Consistency During the Study Intervention Period

    Stool consistency was measured twice daily, once in the morning and once in the evening eDiary, using the 7-point ordinal pediatric Bristol Stool Form Scale (p-BSFS): Type 1: Looks like small hard lumps or balls, like pebbles; Type 2: Looks like fat sausage shape but lumpy and hard; Type 3: Looks like a sausage but with cracks on it; Type 4: Looks like a sausage or snake, smooth and soft; Type 5: Looks like chicken nuggets, soft smooth blobs; Type 6: Looks like oatmeal, fluffy mushy pieces; Type 7: Looks like a milkshake, watery. A participant's p-BSFS score for the study intervention period was the average of the non-missing p-BSFS scores from the SBMs reported by the participant during the 12-week study intervention period.

    Measured: Baseline, up to 12 weeks

  2. Irritable Bowel Syndrome With Constipation (IBS-C) Participants: Change From Baseline in 12-week SBM Frequency Rate (SBMs/Week) During the Study Intervention Period

    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. Assessments of BM characteristics that determine occurrences of SBM (ie, BM frequency and rescue medication use) were measured by using the eDiary completed twice daily (morning and evening) on the eDiary (Electronic Diary) device. A participant's SBMs/week for the study intervention period was the average of the non-missing SBMs/week reported by the participant during the 12-week study intervention period.

    Measured: Baseline, up to 12 Weeks

  3. Irritable Bowel Syndrome With Constipation (IBS-C) Participants: Change From Baseline in 12-week Abdominal Pain During the Study Intervention Period

    Assessments of abdominal pain were measured twice daily, once in the morning and once in the evening eDiary, using a 5-point scale where a score of 0 indicates no abdominal pain scores and a score of 4 indicates a lot of abdominal pain. Assessments of abdominal pain were measured using a 5-point scale where '0' indicates no abdominal pain and '4' indicates a lot of abdominal pain. The participant's abdominal pain score was derived as the mean of the non-missing morning and evening abdominal pain scores during the specified period.

    Measured: Baseline, up to 12 weeks

  4. Irritable Bowel Syndrome With Constipation (IBS-C) Participants: Change From Baseline in 12-week Stool Consistency During the Study Intervention Period

    Stool consistency was measured twice daily, once in the morning and once in the evening eDiary, using the 7-point ordinal p-BSFS (pediatric Bristol Stool Form Scale: Type 1: Looks like small hard lumps or balls, like pebbles Type 2: Looks like fat sausage shape but lumpy and hard Type 3: Looks like a sausage but with cracks on it Type 4: Looks like a sausage or snake, smooth and soft Type 5: Looks like chicken nuggets, soft smooth blobs Type 6: Looks like oatmeal, fluffy mushy pieces Type 7: Looks like a milkshake, watery. A participant's p-BSFS score for the study intervention period was the average of the non-missing p-BSFS scores from the SBMs reported by the participant during the 12-week study intervention period.

    Measured: Baseline, up to 12 weeks

  5. Irritable Bowel Syndrome With Constipation (IBS-C) Participants: 6/12 Weeks SBM + 2 Responder Rate

    A 6/12 weeks SBM + 2 responder is a participant that meets the weekly SBM + 2 responder criteria for at least 6 out of the 12 weeks of the intervention period. A weekly SBM +2 responder is a participant who has an increase of at least 2 in the SBM weekly rate from baseline, Assessments of BM characteristics that determine occurrences of SBMs (ie, BM frequency and rescue medication use) were measured by using an eDiary completed twice daily (morning and evening). Responder rate is presented as the percentage of participants who were 6/12 weeks SBM + 2 responders.

    Measured: 12 weeks

  6. Irritable Bowel Syndrome With Constipation (IBS-C) Participants: 6/12 Weeks Abdominal Pain Responder

    A 6/12 weeks abdominal pain responder is a participant that meets the weekly abdominal pain responder criteria for at least 6 out of the 12 weeks of the intervention period. A weekly abdominal pain responder is a participant who has a decrease of at least 30% in the mean abdominal pain score from baseline, during that study intervention week. Assessments of abdominal pain were measured by using an eDiary completed twice daily (morning and evening) and were measured using a 5-point scale where '0' indicates no abdominal pain and '4' indicates a lot of abdominal pain. The participant's abdominal pain score was derived as the mean of the non-missing abdominal pain scores during the specified period. Responder rate is presented as the percentage of participants who were 6/12 weeks abdominal pain responders.

    Measured: 12 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2019
  2. Study start1 Oct 2019
  3. Primary completion20 May 2024
  4. Study completion29 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
438 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04026113
Sponsor's protocol ID
LIN-MD-64
Other IDs
2019-001500-38, 2019
Status last verified
Oct 2024
First submitted
17 Jul 2019
Last updated
26 Nov 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Publications

  • Person H, Hyams JS, Sanghavi RM, Shakhnovich V, Kosch K, Li M, D'Achino D, Khlevner J, Chumpitazi BP, Saps M. A post hoc analysis of linaclotide in pediatric patients with functional constipation and neurodevelopmental disorders. J Pediatr Gastroenterol Nutr. 2026 Jul;83(1):21-28. doi: 10.1002/jpn3.70424. Epub 2026 Mar 30.

    PubMed 41913506

  • Di Lorenzo C, Khlevner J, Rodriguez-Araujo G, Xie W, Huh SY, Ando M, Hyams JS, Nurko S, Benninga MA, Simon M, Hewson ME, Saps M. Efficacy and safety of linaclotide in treating functional constipation in paediatric patients: a randomised, double-blind, placebo-controlled, multicentre, phase 3 trial. Lancet Gastroenterol Hepatol. 2024 Mar;9(3):238-250. doi: 10.1016/S2468-1253(23)00398-9. Epub 2024 Jan 8.

    PubMed 38211604

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Linaclotide in people with Functional Constipation and Irritable Bowel Syndrome With Constipation, run by AbbVie at 115 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 45 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 115 sites in United States, Israel, Canada, Bulgaria, Poland and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional Constipation (FC) Participants: Change From Baseline in 12-week SBM (Spontaneous Bowel Movement) Frequency Rate (SBMs/Week) During the Study Intervention Period (time frame: Baseline, up to 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04026113, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2024.

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