LIN-MD-66 is a Phase 3 open-label study with 24 weeks (Functional Constipation participants) or 52 weeks (Irritable bowel syndrome with constipation participants) of linaclotide exposure that will enroll pediatric participants (6-17 years of age) with FC or IBS-C who completed study intervention in studies LIN-MD-62, LIN-MD-63, or LIN-MD-64 based on the individual study criteria.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
381
Participants who completed study LIN-MD-63 at their time of enrollment will be assigned a dose of 290 μg. Participants who received ≤ 145 μg linaclotide or placebo in study LIN-MD-63 at the time of completion will continue to receive 145 μg. Participants who completed study LIN-MD-64 at their time of enrollment will be assigned a dose of 290 μg if they choose to receive open-label or continue to receive blinded dose of 145 or 290 μg if they choose to remain on the same blinded dose.
Participants whom are between the ages of 6-11 years old at their time of enrollment will be assigned a dose of 72 μg. Participants whom are between the ages of 12-17 years old at their time of enrollment will be randomized at 1:1 ratio to 72 or 145 μg linaclotide.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs).
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.
Time frame: From first dose of study drug until 30 days following last dose of study drug [up to 24 weeks (FC participants) or 52 weeks (IBS-C participants)].
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Central Research Associates /ID# 237953
Birmingham, Alabama, United States
G & L Research, LLC /ID# 238093
Foley, Alabama, United States
The Center for Clinical Trials Inc. /ID# 234605
Saraland, Alabama, United States
HealthStar Research of Hot Springs PLLC /ID# 234608
Hot Springs, Arkansas, United States
Preferred Research Partners /ID# 237109
Little Rock, Arkansas, United States
Applied Research Center of Arkansas /ID# 238069
Little Rock, Arkansas, United States
Advanced Research Center /ID# 237960
Anaheim, California, United States
Kindred Medical Institute, LLC /ID# 237367
Corona, California, United States
Duplicate_Center for Clinical Trials LLC /ID# 234629
Paramount, California, United States
Medical Ctr for Clin Research /ID# 236911
San Diego, California, United States
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