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NCT04026113 · ClinicalTrials.gov registry record · Phase 3
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)
A Phase 3 study, sponsored by AbbVie.
- Completed
- Registry status
- Phase 3
- Development phase
- 438
- Enrollment target
NCT04026113 is a Phase 3 study that has completed, run by AbbVie. The registered enrollment target is 438 participants.
The verdict
NCT04026113, a Phase 3 study, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 438 participants
- Enrollment target
Study 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 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 IBS and modified Rome III criteria for child/adolescent FC.
Interventions
- DRUG Placebo
- DRUG Linaclotide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 438 participants |
| Start Date | 2019-10-01 |
| Est. Completion | 2024-05-29 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04026113
The ClinicalTrials.gov registry entry for NCT04026113 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 438 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04026113 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04026113 about?
NCT04026113 is a clinical study titled "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)". 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 FC. The objective of LIN-MD-64 is to evaluate the...
What is the current status of trial NCT04026113?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 438 participants. The study started on 2019-10-01. Estimated completion is 2024-05-29.
What interventions are being tested in trial NCT04026113?
The interventions under investigation include: Placebo (DRUG), Linaclotide (DRUG).
Who is sponsoring clinical trial NCT04026113?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
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