Number of Participants With Treatment-Emergent Adverse Events (TEAEs).
| Group | Value (Participants) |
|---|---|
| FC 72 ug Linaclotide | 37 |
| FC 145 ug Linaclotide | 15 |
| IBS-C 145 ug Linaclotide | 4 |
| IBS-C 290 ug Linaclotide | 31 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataUnited States, Canada, Israel, Netherlands
1 trial · 1 completed · 1 with posted results
Long-term Safety of Linaclotide in Pediatric Participants With FC or IBS-C
NCT0416605819 Nov 2019 to 5 Jun 2025
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Active comparator
72 μg linaclotide
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.
Active comparator
145 μg linaclotide
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.
Active comparator
290 μg linaclotide
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.
Outcomes the sponsor listed as primary.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs).
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)].
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.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (Participants) |
|---|---|
| FC 72 ug Linaclotide | 37 |
| FC 145 ug Linaclotide | 15 |
| IBS-C 145 ug Linaclotide | 4 |
| IBS-C 290 ug Linaclotide | 31 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| FC 72 ug LinaclotideFunctional Constipation (FC) participants who completed lead-in studies LIN-MD-62 or LIN-MD-64 were dosed as follows in this study: Participants aged 6 to 11 years received an open-label dose of linaclotide 72 ug, oral capsule, once daily for 24 weeks. Participants aged 12 to 17 years were randomized to receive an open-label dose of linaclotide either 72 or 145 ug, oral capsule, once daily for 24 weeks. | 0 / 210 | 2 / 210 | 14 / 210 |
| FC 145 ug LinaclotideFunctional Constipation (FC) participants who completed lead-in studies LIN-MD-62 or LIN-MD-64 were dosed as follows in this study: Participants aged 12 to 17 years were randomized to receive an open-label dose of linaclotide either 72 or 145 ug, oral capsule, once daily for 24 weeks. | 0 / 73 | 0 / 73 | 5 / 73 |
| IBS-C 145 ug LinaclotideIrritable Bowel Syndrome with Constipation (IBS-C) participants were dosed as follows: Participants who received ≤ 145 ug linaclotide or placebo in lead-in study LIN-MD-63, in this study received an open-label dose of linaclotide 145 ug, oral capsule, once daily for 52 weeks. Participants who completed lead-in study LIN-MD-64, in this study had the option to either remain on the same blinded linaclotide dose they were receiving in lead-in study LIN-MD-64 (145 or 290 ug) or received an open-label dose of linaclotide 290 ug, oral capsule, once daily for 52 weeks. | 0 / 22 | 0 / 22 | 0 / 22 |
| IBS-C 290 ug LinaclotideIrritable Bowel Syndrome with Constipation (IBS-C) participants were dosed as follows: Participants who completed lead-in study LIN-MD-63, in this study received an open-label dose of linaclotide 290 ug, oral capsule, once daily for 52 weeks. Participants who completed lead-in study LIN-MD-64, in this study had the option to either remain on the same blinded linaclotide dose they were receiving in lead-in study LIN-MD-64 (145 or 290 ug) or received an open-label dose of linaclotide 290 ug, oral capsule, once daily for 52 weeks. | 0 / 76 | 2 / 76 | 11 / 76 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
No study cites this trial.
Who could join, as posted.
PepBank is a research reference. Talk to a doctor before you use any peptide.
In PepBank now:147 peptides, 6 blends and 13 other compounds97,577 study results from 17,383 studies8,473 clinical trialsUpdated