# Long-term Safety of Linaclotide in Pediatric Participants With FC or IBS-C

> **NCT04166058** · PHASE3 · COMPLETED · sponsor: **AbbVie** · enrollment: 381 (actual)

## Conditions studied

- Irritable Bowel Syndrome With Constipation
- Functional Constipation

## Interventions

- **DRUG:** Irritable Bowel Syndrome with Constipation (IBS-C) participants (LIN-MD-63 and LIN-MD-64 completers)
- **DRUG:** Functional Constipation (FC) participants (LIN-MD-62 and LIN-MD-64 completers)

## Key facts

- **NCT ID:** NCT04166058
- **Lead sponsor:** AbbVie
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2019-11-19
- **Primary completion:** 2025-06-05
- **Final completion:** 2025-06-05
- **Target enrollment:** 381 (ACTUAL)
- **Last updated:** 2026-01-06

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04166058

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04166058, "Long-term Safety of Linaclotide in Pediatric Participants With FC or IBS-C". Retrieved via AI Analytics 2026-06-09 from https://api.ai-analytics.org/clinical/NCT04166058. Licensed CC0.

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