Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Irritable Bowel Syndrome with Constipation participants · 1 trial · 2 indications
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.
| Arm | Type | Description |
|---|---|---|
| 72 μg linaclotide | ACTIVE_COMPARATOR | An oral capsule that is taken once daily. It may be taken whole or sprinkled into 1 teaspoonful of applesauce or 30mL of bottled water. |
| 145 μg linaclotide | ACTIVE_COMPARATOR | An oral capsule that is taken once daily. It may be taken whole or sprinkled into 1 teaspoonful of applesauce or 30mL of bottled water. |
| 290 μg linaclotide | ACTIVE_COMPARATOR | An oral capsule that is taken once daily. It may be taken whole or sprinkled into 1 teaspoonful of applesauce or 30mL of bottled water. |
| Name | Type | Description |
|---|---|---|
| Irritable Bowel Syndrome with Constipation (IBS-C) participants (LIN-MD-63 and LIN-MD-64 completers) | DRUG | 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. |
| Functional Constipation (FC) participants (LIN-MD-62 and LIN-MD-64 completers) | DRUG | 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. |
Inclusion Criteria: * Participant weighs ≥ 18 kg at the time the parent/guardian/LAR and/or caregiver has provided signed consent. * Female participants who have had their first menstrual period and are sexually active must agree to use a reliable form of contraception. * Participants must have com...