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Label indication LINZESS is indicated for the treatment of: • irritable bowel syndrome with constipation (IBS-C) in adults and pediatric patients 7 years of age and older • chronic idiopathic constipation (CIC) in adults • functional constipation (FC) in pediatric patients 2 years of age and older LINZESS is a guanylate cyclase-C agonist indicated for treatment of: Irritable bowel syndrome with constipation (IBS-C) in adults and… FDA label
Also known as LINZESS
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 developed by Ironwood Pharmaceuticals, Inc. (ticker IRWD) for functional constipation in children ages 6 to 17 years. It is a Phase 2 candidate in the gastrointestinal therapeutic area and has been studied in a single completed clinical trial.
LIN Dose A is being developed to treat functional constipation in children ages 6 to 17 years who meet modified Rome III criteria for child and adolescent functional constipation. The condition is the sole indication studied for this asset, and development remains at the Phase 2 stage.
LIN Dose A is developed by Ironwood Pharmaceuticals, Inc., which trades under the ticker IRWD. Ironwood is the sponsor of the clinical program evaluating the drug in pediatric functional constipation, and no other developer is associated with the asset.
LIN Dose A is in Phase 2 development. It is investigational and has not been approved by the FDA. One Phase 2 trial has been completed, and no trials are currently active, so the program has finished its only listed study to date.
LIN Dose A has been evaluated in one completed Phase 2 trial, NCT02559570, titled a safety and efficacy study of a range of linaclotide doses given orally to children ages 6 to 17 years with functional constipation. The trial enrolled 173 participants across the United States and Canada.
The Phase 2 trial NCT02559570 was randomized, double blind, and placebo controlled, enrolling 173 children ages 6 to 17 years with functional constipation. It was conducted in the United States and Canada, did not enroll healthy volunteers, and has been completed.