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
- Apr 5, 2024
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- participants needed
- 426
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- sponsor
- Allergan
Summary
The objective of LIN-MD-64 is to evaluate the safety and efficacy of 12 weeks of linaclotide therapy (72 μg daily) in comparison with placebo in pediatric participants, 6 to 17 years of age, who fulfill modified Rome III Criteria for Child/Adolescent Functional Constipation (FC). The objective of LIN-MD-64 is to evaluate the safety and efficacy of 12 weeks of linaclotide therapy (145 μg or 290 μg daily) in pediatric participants, 7 to 17 years of age, who fulfill the Rome III criteria for child/adolescent Irritable Bowel Syndrome (IBS) and modified Rome III criteria for child/adolescent Functional Constipation (FC).
Details
| Condition | Functional Constipation, Irritable Bowel Syndrome With Constipation |
|---|---|
| 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 | 10 July 2022 |
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