A Study to Assess Adverse Events and Change in Symptoms With Linaclotide Versus Placebo in Pediatric Subjects, Ages 2 to 5 Years, With Functional Constipation
Functional Constipation (FC), Chronic Idiopathic Constipation (CIC)
About this trial
This is an interventional treatment trial for Functional Constipation (FC) focused on measuring Functional Constipation (FC), Linaclotide, AGN-182139, Linzess
Eligibility Criteria
Inclusion Criteria: Caregiver/parent/guardian/legally authorized representative (LAR) is willing and able to comply with procedures required in this protocol, prior to the initiation of any screening or study-specific procedures. In addition, the caregiver/parent/guardian/LAR who will be completing the electronic diary (eDiary) must be able to read and understand the assessments in the eDiary device and undergo training. Participant meets modified Rome IV criteria for FC: For at least 1 month before Screening (Visit 1), 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. At least 1 episode of fecal incontinence per week after the acquisition of toileting skills. Exclusion Criteria: Participant history of: 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 (i.e., participant reports having streaks of blood on the stool or on toilet paper and/or pain/crying with BM 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 IV FC criteria, the participant would not be eligible to participate in the study. Anatomic malformations (e.g., imperforate anus, anal stenosis, anterior displaced anus) Intestinal nerve or muscle disorders (e.g., Hirschprung disease, visceral myopathies, visceral neuropathies) Neuropathic conditions (e.g., 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 Childhood functional abdominal pain syndrome 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 symptoms which could confound the assessments in this study History of cancer. (Note: participants with a history of cancer are allowed provided that the malignancy has been in a complete remission before Randomization (Visit 2). A complete remission is defined as the disappearance of all signs of cancer in response to treatment.) Has conditions that could interfere with drug absorption including but not limited to short bowel syndrome.
Sites / Locations
- G & L Research, LLC /ID# 250658Recruiting
- HealthStar Research of Hot Springs PLLC /ID# 249481Recruiting
- Applied Research Center of Arkansas /ID# 249764Recruiting
- Advanced Research Center /ID# 249412Recruiting
- Medical Ctr for Clin Research /ID# 254386Recruiting
- Prohealth Research Center /ID# 249420Recruiting
- KIDZ Medical Services - Hollywood /ID# 250823Recruiting
- Kissimmee Clinical Research /ID# 252206Recruiting
- South Florida Research Ph I-IV /ID# 252350Recruiting
- South Miami Medical & Research Group Inc. /ID# 249418Recruiting
- Valencia Medical & Research Center /ID# 250452Recruiting
- Palmetto Professional Research /ID# 250875Recruiting
- Rophe Adult and Pediatric Medicine/SKYCRNG /ID# 250663Recruiting
- Michael W. Simon, MD, PSC /ID# 250664Recruiting
- Virgo Carter Pediatrics /ID# 249483Recruiting
- Michigan Center of Medical Research /ID# 251088Recruiting
- MNGI Digestive Health, P. A. /ID# 249676Recruiting
- Velocity Clinical Research- Hastings Nebraska /ID# 252132Recruiting
- UH Cleveland Medical Center /ID# 250893Recruiting
- IPS Research Company /ID# 250822
- Frontier Clinical Research, LLC - Scottdale /ID# 250656Recruiting
- Frontier Clinical Research /ID# 250657Recruiting
- Coastal Pediatric Research - West Ashley B /ID# 249413Recruiting
- Tribe Clinical Research LLC /ID# 255656Recruiting
- Coastal Pediatric Research - Summerville /ID# 249423Recruiting
- Tullahoma Pediatrics /ID# 250892Recruiting
- Houston Clinical Research Associates /ID# 250779Recruiting
- ClinPoint Trials /ID# 250448Recruiting
- Carilion Medical Center /ID# 249790Recruiting
- Frontier Clinical Research - Kingwood /ID# 251154Recruiting
- Doncaster Royal Infirmary /ID# 252080Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Part 1 Linaclotide
Part 1 Placebo
Part 2 Linaclotide
Participants will receive linaclotide for 12 weeks.
Participants will receive placebo for 12 weeks.
Participants who completed study intervention in Part 1 of this study or the Phase 2 Study LIN-MD-67 will receive 24 weeks of linaclotide exposure.