Linaclotide Safety and Efficacy in Pediatric Participants 6 to 17 Years of Age With Irritable Bowel Syndrome With Constipation (IBS-C) or Functional Constipation (FC)
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- STATUS
- Recruiting
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- End date
- Dec 14, 2022
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- participants needed
- 426
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- sponsor
- Allergan
Clinical Trials Registry Team
Primary Contact
Children's National Medical Center (5.3 mi away) Contact
+152 other locationSummary
The objective of LIN-MD-64 is to evaluate the safety and efficacy of 12 weeks of linaclotide therapy (72 g daily) in comparison with placebo in pediatric participants, 6 to 17 years of age, who fulfill modified Rome III Criteria for Child/Adolescent FC.
The objective of LIN-MD-64 is to evaluate the safety and efficacy of 12 weeks of linaclotide therapy (145 g or 290 g daily) in pediatric participants, 7 to 17 years of age, who fulfill the Rome III criteria for child/adolescent IBS and modified Rome III criteria for child/adolescent FC
Details
| Treatment | Placebo, Linaclotide 72 μg, Linaclotide 72 μg (FC Participants), Placebo (FC Participants), Linaclotide 145 μg (IBS-C Participants), Linaclotide 290 μg (IBS-C Participants) |
|---|---|
| Clinical Study Identifier | NCT04026113 |
| Sponsor | Allergan |
| Last Modified on | 16 January 2021 |
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