Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LIN Dose A · 1 trial · 1 indication
SBM was defined as a BM that occurred in the absence of laxative, suppository, or enema use on the calendar day of the BM or the calendar day before the BM. SBM rate was defined as SBMs/week during the 4-week Treatment period. Participants recorded the occurrence of BMs and use of rescue medication, morning and evening, daily in an eDiary since pretreatment period. The SBM frequency rate (SBMs/week) during the analysis period for each participant were calculated as \[(total number of SBMs in the analysis period/number of days in the analysis period)\*7\]. Baseline value was based on values collected 14 days before randomization up to randomization. Change from Baseline was calculated as the SBM frequency rate during the 4-week treatment period - SBM frequency rate at baseline. A positive change from Baseline indicates improvement. Least squares mean (LSM) and standard error (SE) were calculated using analysis of covariance (ANCOVA) method.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Participants aged 6 to 11 or 12 to 17 years received matching placebo linaclotide (LIN), 30 minutes before evening meal, once daily for 4 weeks. Administered as liquid oral solution for participants 6 to 11 years of age and solid oral capsule or liquid oral solution for participants 12 to 17 years of age. |
| LIN Dose A (9 ug or 18 ug) | EXPERIMENTAL | Participants aged 6 to 11 years with weight 18 to \<35 kg received LIN 9 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 6 to 11 years with weight ≥35 kg received LIN 18 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 12 to 17 years received LIN 18 ug, oral solution or solid capsules, 30 minutes before evening meal, once daily for 4 weeks. |
| LIN Dose B (18 ug or 36 ug) | EXPERIMENTAL | Participants aged 6 to 11 years with weight 18 to \<35 kg received LIN 18 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 6 to 11 years with weight ≥35 kg received LIN 36 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 12 to 17 years received LIN 36 ug, oral solution or solid capsules, 30 minutes before evening meal, once daily for 4 weeks. |
| LIN Dose C (36 ug or 72 ug) | EXPERIMENTAL | Participants aged 6 to 11 years with weight 18 to \<35 kg received LIN 36 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 6 to 11 years with weight ≥35 kg received LIN 72 ug, oral solution, 30 minutes before evening meal, once daily for 4 weeks. Participants aged 12 to 17 years received LIN 72 ug, oral solution or solid capsules, 30 minutes before evening meal, once daily for 4 weeks. |
| LIN 145 µg | EXPERIMENTAL | Participants aged 12 to 17 years received LIN 145 ug, oral solution or solid capsules, 30 minutes before evening meal, once daily for 4 weeks. |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Participants received matching placebo LIN liquid solution or solid capsules, orally, 30 minutes before evening meal, once daily for 4 weeks. |
| LIN Dose A | DRUG | Participants received LIN 9 or 18 ug liquid solution or solid capsules, orally, 30 minutes before evening meal, once daily for 4 weeks. |
| LIN Dose B | DRUG | Participants received LIN 18 or 36 ug liquid solution or solid capsules, orally, 30 minutes before evening meal, once daily for 4 weeks. |
| LIN Dose C | DRUG | Participants received LIN 36 or 72 ug liquid solution or solid capsules, orally, 30 minutes before evening meal, once daily for 4 weeks. |
| LIN 145 µg | DRUG | Participants received LIN 145 µg, liquid solution or solid capsules, 30 minutes before evening meal, once daily for 4 weeks. |
Inclusion Criteria: * Participant weighs at least 18 kg (kilograms) (39.7 lbs) * Participant meets modified Rome III criteria for child/adolescent FC: For at least 2 months before the Screening Visit, the participant has had 2 or fewer defecations (with each defecation occurring in the absence of a...
LIN Dose A is an investigational small molecule being studied for the treatment of Functional Constipation in Children Ages 6-17 Years. It is a gastrointestinal therapeutic currently in Phase 2 clinical development, and it is not yet approved by regulatory authorities.
LIN Dose A is being developed by Ironwood Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker IRWD. The company is conducting clinical research to evaluate the safety and efficacy of this investigational drug in pediatric patients with functional constipation.
LIN Dose A is in Phase 2 clinical development. It has completed one Phase 2 trial, and it remains an investigational drug. It has not been approved by the FDA or any other regulatory agency, and its safety and efficacy have not been established.
LIN Dose A has been studied in one completed Phase 2 clinical trial, registered as NCT02559570. This randomized, double-blind, placebo-controlled study enrolled 173 children aged 6-17 years with functional constipation and was conducted in the United States and Canada.
LIN Dose A is a dose of linaclotide, a small molecule being evaluated by Ironwood Pharmaceuticals. The clinical trial NCT02559570 studied a range of linaclotide doses, including LIN Dose A, administered orally to children with functional constipation.