Linaclotide Safety and Efficacy in 2 to 5-Year-Old Participants With Functional Constipation

Completed · Phase 2 · Has a placebo group

Conditions studied: Functional Constipation

In brief

The purpose of this study is to evaluate the dose response, safety, and efficacy of linaclotide when compared with placebo in pediatric participants, 2 to 5 years of age, with Functional Constipation.

Key facts

Study ID

NCT04110145

Run by

Allergan

People needed

35

Starts

2019-10-14

Expected to finish

2021-04-20

Last updated by the study team

2022-04-26

Who can join

Age: 2 and older, up to 5. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant weighs ≥10 kilograms (kg) at the time the parent/guardian/legally authorized representative (LAR) has provided signed consent
• Participant meets modified Rome III criteria for FC: For at least 2 months before Screening (Visit 1) (for participants aged ≥ 4 years old), or for at least 1 month before Screening (Visit 1) (for participants aged < 4 years old), 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) per week.
• In addition, at least once per week, participant 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 diameter stools that may obstruct the toilet
• At least one episode of fecal incontinence per week after the acquisition of toileting skills
• Participant is willing to discontinue any laxatives used before the Preintervention Visit in favor of the protocol-permitted rescue medicine
• Parent/guardian/LAR and caregiver must provide written informed consent before the initiation of any study-specific procedures
• Caregiver who will be completing the eDiary is able to read and/or understand the assessments in the eDiary device and must undergo training

You may not qualify if…

• For participants aged ≥ 4 years old: Participant meets Rome III criteria for Child/Adolescent IBS: At least once per week for at least 2 months before Screening (Visit 1), 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 has required manual dis-impaction any time prior to randomization or dis-impaction during in-patient hospitalization within 1 year 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 had surgery that meets any of the following criteria:
• Surgery to remove a segment of the GI tract at any time before Screening (Visit 1)
• 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 Screening (Visit 1)
• Other major surgery during the 30 days before Screening (Visit 1)
• Participant has a mechanical bowel obstruction or pseudo-obstruction.
• Participant has a known allergy or sensitivity to the study intervention or its components or other medications in the same drug class
• 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 or treated with thyroid hormone at a dose that has not been stable for at least 3 months prior to Screening (Visit 1)
• Down's syndrome or any other chromosomal disorder
• Active anal fissure (ie, participant reports having streaks of blood on the stool or on toilet paper and/or pain/crying with bowel movement within 2 weeks prior to Screening). (Note: Anal fissures that have resolved at least 2 weeks prior to screening would not be exclusionary.) However, if in the investigator's opinion, an anal fissure(s) may be the primary cause of participant's modified Rome III FC criteria, the participant would not be eligible to participate in the study.
• 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 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

Where it is running

• Central Research Associates, Inc — Birmingham, Alabama, United States
• HealthStar Research — Hot Springs, Arkansas, United States
• Preferred Clinical Research Partners — Little Rock, Arkansas, United States
• Advanced Research Center — Anaheim, California, United States
• Kindred Medical Institute for Clinical Trials, LLC — Corona, California, United States
• Center for Clinical Trials, LLC — Paramount, California, United States
• Prohealth Research Center — Doral, Florida, United States
• South Miami Medical & Research Group, Inc. — Miami, Florida, United States
• River Birch Research Alliance, LLC — Blue Ridge, Georgia, United States
• SleepCare Research Institute, Inc. — Stockbridge, Georgia, United States
• Virgo Carter Pediatrics — Silver Spring, Maryland, United States
• Minnesota Gastroenterology PA — Minneapolis, Minnesota, United States
• David M. Headley, MD, P.A. — Port Gibson, Mississippi, United States
• Foundation Pediatrics Med Clinical Research Partners, LLC — East Orange, New Jersey, United States
• Advantage Clinical Trials — The Bronx, New York, United States
• Coastal Pediatric Research — Charleston, South Carolina, United States
• Coastal Pediatric Research — Mt. Pleasant, South Carolina, United States
• Clinical Research Partners, LLC — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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