drugset / Trial / NCT04166058
Long-term Safety of Linaclotide in Pediatric Participants With FC or IBS-C
Non-randomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2019-11-19
- Primary completion
- 2025-06-05
- Completion
- 2025-06-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Linaclotide | Peptide | 72 ug | Oral |
| Comparator | Linaclotide | Peptide | 145 ug | Oral |
| Comparator | Linaclotide | Peptide | 290 ug | Oral |