Long-term Safety of Linaclotide in Pediatric Participants With FC or IBS-C (NCT04166058) | Clinical Trial Compass
CompletedPhase 3
Long-term Safety of Linaclotide in Pediatric Participants With FC or IBS-C
United States381 participantsStarted 2019-11-19
Plain-language summary
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.
Who can participate
Age range6 Years – 18 Years
SexALL
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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 completed study intervention in their lead-in study.
Inclusion Criteria for Phase 2 LIN-MD-62 or Phase 2 LIN-MD-63 and Phase 3 LIN-MD-64 completers who enroll in LIN-MD-66 after \>28 days from last study intervention:
\- Female participants of childbearing potential must have a negative serum pregnancy test at the Screening Visit (Visit 1) and negative urine pregnancy test prior to the first dose on the Day 1 Visit (Visit 2).
Exclusion Criteria:
* Participant has a known allergy or sensitivity to the study intervention or its components or other medications in the same drug class.
* Participant received an investigational drug, other than linaclotide, during the 30 days before the Screening Visit (Visit 1) or is planning to receive an investigational drug (other than that administered during this study) or use an investigational device at any time during the study.
* Female participants who are currently pregnant or nursing, or plan to become pregnant or nurse during the clinical study.
* Participant has required manual disimpaction any time prior to study intervention or disimpaction during in-patient hospitalization within 1 year prior to study intervention.
* Participant has an…
What they're measuring
1
Number of Participants With Treatment-Emergent Adverse Events (TEAEs).
Timeframe: 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)].