deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT03573908

A Trial of Linaclotide 290 μg in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

A Phase 3b, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial of Linaclotide 290 μg Administered Orally for 12 Weeks Followed by a 4-week Randomized Withdrawal Period in Patients With Irritable Bowel Syndrome With Constipation

Sponsor: Allergan Sales, LLC

Updated 11 times since 2018 Last updated: Nov 13, 2020 Started: Jun 20, 2018 Primary completion: Mar 13, 2019 Completion: Apr 10, 2019
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT03573908, this PHASE3 trial focuses on Irritable Bowel Syndrome Characterized by Constipation and remains completed. Sponsored by Allergan Sales, LLC, it has been updated 11 times since 2018, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Study Description(click to expand)

This study consists of a 12-week Treatment Period followed by 4-week Randomized Withdrawal (RW) Period.

This study consists of a 12-week Treatment Period followed by 4-week Randomized Withdrawal (RW) Period.

Status Flow

~Jul 2018 – ~Aug 2018 · 31 days · monthly snapshotNot Yet Recruiting~Aug 2018 – ~Oct 2018 · 2 months · monthly snapshotRecruiting~Oct 2018 – ~Feb 2019 · 4 months · monthly snapshotRecruiting~Feb 2019 – ~Apr 2020 · 14 months · monthly snapshotActive Not Recruiting~Apr 2020 – ~Dec 2020 · 8 months · monthly snapshotCompleted~Dec 2020 – ~Jan 2021 · 31 days · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – present · 7 months · monthly snapshotCompleted~Jan 2026 – present · 3 months · monthly snapshotCompleted

Change History

11 versions recorded
  1. Jan 2026 — Present [monthly]

    Completed PHASE3

  2. Sep 2025 — Present [monthly]

    Completed PHASE3

  3. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE3

  4. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  5. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE3

Show 6 earlier versions
  1. Dec 2020 — Jan 2021 [monthly]

    Completed PHASE3

  2. Apr 2020 — Dec 2020 [monthly]

    Completed PHASE3

    Status: Active Not RecruitingCompleted

  3. Feb 2019 — Apr 2020 [monthly]

    Active Not Recruiting PHASE3

    Status: RecruitingActive Not Recruiting

  4. Oct 2018 — Feb 2019 [monthly]

    Recruiting PHASE3

  5. Aug 2018 — Oct 2018 [monthly]

    Recruiting PHASE3

    Status: Not Yet RecruitingRecruiting

  6. Jul 2018 — Aug 2018 [monthly]

    Not Yet Recruiting PHASE3

    First recorded

Jun 2018

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Allergan Sales, LLC
  • Ironwood Pharmaceuticals, Inc.
Data source: Ironwood Pharmaceuticals, Inc.

For direct contact, visit the study record on ClinicalTrials.gov .