deltatrials
Terminated PHASE4 INTERVENTIONAL 2-arm NCT02788123

A Study To Assess The Efficacy And Safety Of Bismuth Tripotassium Dicitrate (De-Nol) In Combination With Pantoprazole And Pantoprazole Monotherapy In Treatment Of Subjects With Nonsteroidal Anti-Inflammatory Drugs (NSAID)-Induced Gastropathy (BiGARD)

Phase IV, Multicenter, Open Label, Randomized Study in Parallel Groups To Assess The Efficacy And Safety Of Bismuth Tripotassium Dicitrate (De-Nol®) In Combination With Pantoprazole And Pantoprazole Monotherapy In Treatment Of Patients With NSAID Induced Gastropathy

Sponsor: Astellas Pharma Europe B.V.

Updated 9 times since 2017 Last updated: Sep 19, 2017 Started: Mar 3, 2017 Primary completion: May 29, 2017 Completion: Jun 13, 2017
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Internal reassessment of the medicinal product development strategy by Sponsor

A PHASE4 clinical study on NSAID-induced Gastropathy, this trial is terminated or withdrawn. The trial is conducted by Astellas Pharma Europe B.V. and has accumulated 9 data snapshots since 2017. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

~Jan 2017 – ~Apr 2017 · 3 months · monthly snapshotNot Yet Recruiting~Apr 2017 – ~May 2017 · 30 days · monthly snapshotNot Yet Recruiting~May 2017 – ~Oct 2017 · 5 months · monthly snapshotRecruiting~Oct 2017 – ~Jun 2018 · 8 months · monthly snapshotTerminated~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotTerminated~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotTerminated~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotTerminated~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotTerminated~Sep 2025 – present · 12 months · monthly snapshotTerminated

Change History

9 versions recorded
  1. Sep 2025 — Present [monthly]

    Terminated PHASE4

  2. Sep 2024 — Sep 2025 [monthly]

    Terminated PHASE4

  3. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE4

  4. Jan 2021 — Jul 2024 [monthly]

    Terminated PHASE4

  5. Jun 2018 — Jan 2021 [monthly]

    Terminated PHASE4

Show 4 earlier versions
  1. Oct 2017 — Jun 2018 [monthly]

    Terminated PHASE4

    Status: RecruitingTerminated

  2. May 2017 — Oct 2017 [monthly]

    Recruiting PHASE4

    Status: Not Yet RecruitingRecruiting

  3. Apr 2017 — May 2017 [monthly]

    Not Yet Recruiting PHASE4

  4. Jan 2017 — Apr 2017 [monthly]

    Not Yet Recruiting PHASE4

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Astellas Pharma Europe B.V.
Data source: Astellas Pharma Inc

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