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Linaclotide Safety and Efficacy in 2 to 5-Year-Olds

November 5, 2019


Allergen and Ironwood Pharmaceuticals Inc. are holding a clinical trial on the effectiveness of the drug linaclotide (Linzess) in children with functional constipation. Researchers will also monitor the safety and response in children who are administered the drug. 


Study Information

Researchers will give linaclotide to some children and a placebo to others to compare. 

Only children ages 2 to 5 years old are invited to participate. The drug or placebo will be given once daily before a meal. There will be 4 parts in this study, each consisting of 4 weeks. 


Inclusion Criteria

  • Participant who weigh more than 22.0462 lbs at the time when the parent/guardian/legally authorized representative (LAR) has provided signed consent
  • Participant meets the modified Rome III criteria for functional constipation without laxative, suppository, or enema
  • Willing to discontinue any laxatives used before the Preintervention Visit
  • Parent/guardian/LAR and caregiver must provide written informed consent before the start of the study
  • Write understandable statements in the provided eDiary
  • Once per week, participants must meet 1 or more of the following:
    • History of retentive posturing or excessive volitional stool retention
    • History of painful or hard bowel movements (BMs)
    • Presence of a large fecal mass in the rectum
    • History of large stools that may obstruct the toilet
    • At least one episode of fecal incontinence per week after learning toilet skills
    • Caregiver completing the eDiary is able to read and/or understand the assessments in the eDiary device and undergo training


Exclusion Criteria

  • For participants age 4 years and older: Meets Rome III criteria for Child/Adolescent irritable bowel syndrome (IBS): At least once per week for at least 2 months before the first visit, the participant has experienced abdominal discomfort or pain associated with 2 or more of the following at least 25% of the time:
    • Improvement with bowel movements
    • A change in frequency of bowel movements
    • A change in appearance of stool
  • Participant has required manual entry from a gloved index finger to break up hard stool any time during in-patient hospitalization within 1 year prior to study selection
  • Currently has both unexplained 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 had surgery that meets any of the following criteria:
    • Surgery to remove a segment of the GI tract at any time before study
    • Surgery of the abdomen, pelvis, or retroperitoneal structures within 6 months before study
    • An appendectomy or cholecystectomy within 60 days before study
    • Other major surgery within the 30 days before study
  • Participant has a mechanical bowel obstruction or pseudo-obstruction
  • Participant has a known allergy or sensitivity to linaclotide
  • Participant has any of the following conditions:
    • Celiac disease, or positive serological test for celiac disease or the condition is suspected but has not been ruled out by endoscopic biopsy
    • Cystic fibrosis
    • Hypothyroidism that is untreated within 3 months before study
    • Down’s syndrome or any other chromosomal disorder
    • Active anal fissure (streaks of blood on the stool or on toilet paper and/or pain/crying with bowel movement within 2 weeks before study)
    • Anatomic malformations (eg, imperforate anus, anal stenosis, anterior displaced anus)
    • Intestinal nerve or muscle disorders (eg, Hirschsprung disease, visceral myopathies, visceral neuropathies)
    • Neuropathic conditions (eg, spinal cord abnormalities, neurofibromatosis, tethered cord, spinal cord trauma)
    • Lead toxicity
    • Hypercalcemia
    • Neurodevelopmental disabilities
    • Inflammatory bowel disease
    • Childhood functional abdominal pain syndrome
    • Childhood functional abdominal pain
    • Poorly treated or poorly controlled psychiatric disorders
    • Lactose intolerance
    • History of cancer other
  • Participant was in a study during the 30 days before this study or planning on participating in another during this 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
  • For participants ages 4 years and younger: History of non-retentive fecal incontinence



You may participate in this study at the only current recruiting center of Preferred Clinical Research Partners in Little Rock, Arkansas, 72211. If you have any questions call an undisclosed contact person at 501-553-9987. You may also contact the Clinical Trials Registry Team at 877-277-8566 or at



This study is sponsored by Allergen with Anna Muslin as the Principal Investigator.

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