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)

Completed · Phase 3 · Has a placebo group

Conditions studied: Functional Constipation, Irritable Bowel Syndrome With Constipation

In brief

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.

Key facts

Study ID

NCT04026113

Run by

AbbVie

People needed

438

Starts

2019-10-01

Expected to finish

2024-05-29

Last updated by the study team

2024-11-26

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• a. 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:
• 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.

You may not qualify if…

• 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;
• 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;

Where it is running

• G & L Research, LLC /ID# 233139 — Foley, Alabama, United States
• The Center for Clinical Trials Inc. /ID# 232755 — Saraland, Alabama, United States
• HealthStar Research of Hot Springs PLLC /ID# 232757 — Hot Springs, Arkansas, United States
• Preferred Research Partners /ID# 233023 — Little Rock, Arkansas, United States
• Applied Research Center of Arkansas /ID# 233135 — Little Rock, Arkansas, United States
• Advanced Research Center /ID# 233121 — Anaheim, California, United States
• Alliance Research Institute /ID# 232754 — Bell Gardens, California, United States
• Alliance Research Institute Llc /Id# 232637 — Canoga Park, California, United States
• Kindred Medical Institute, LLC /ID# 233042 — Corona, California, United States
• Center for Clinical Trials LLC /ID# 232781 — Paramount, California, United States
• Medical Ctr for Clin Research /ID# 233004 — San Diego, California, United States
• Paragon Rx Clinical Inc /ID# 232752 — Santa Ana, California, United States
• Lynn Institute of Denver /ID# 233137 — Aurora, Colorado, United States
• Children's National Medical Center /ID# 232655 — Washington D.C., District of Columbia, United States
• Prohealth Research Center /ID# 232805 — Doral, Florida, United States
• Dolphin Medical Research /ID# 232815 — Doral, Florida, United States
• Amedica Research Institute Inc /ID# 232809 — Hialeah, Florida, United States
• Nemours Children's Health System /ID# 233127 — Jacksonville, Florida, United States
• Elite Clinical Research /ID# 232801 — Miami, Florida, United States
• My Preferred Research LLC /ID# 233119 — Miami, Florida, United States
• South Miami Medical & Research Group Inc. /ID# 232803 — Miami, Florida, United States
• Valencia Medical & Research Center /ID# 232813 — Miami, Florida, United States
• Advanced Research for Health Improvement /ID# 233161 — Naples, Florida, United States
• Pediatric & Adult Research Center /ID# 232819 — Orlando, Florida, United States
• Central Research Associates /ID# 233124 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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