deltatrials
Completed PHASE1 INTERVENTIONAL 6-arm NCT02099591

Phase I Pharmacokinetics and Safety Study of Naloxegol in Paediatric OIC Patients

A Phase I, Open-Label, Multicentre Study to Assess the Pharmacokinetics and Safety of Naloxegol in Paediatric Patients Ages ≥ 6 Months to < 18 Years Receiving Treatment With Opioids

Sponsor: Kyowa Kirin Pharmaceutical Development Ltd

Conditions Constipation, Signs and Symptoms, Digestive
Interventions Naloxegol
Updated 15 times since 2017 Last updated: Jun 14, 2024 Started: Nov 30, 2014 Primary completion: Apr 30, 2021 Completion: Apr 30, 2021
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT02099591, this PHASE1 trial focuses on Constipation, Signs and Symptoms, Digestive and remains completed. Sponsored by Kyowa Kirin Pharmaceutical Development Ltd, it has been updated 15 times since 2014, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Jan 2018 · 11 months · monthly snapshot~Jan 2018 – ~Jun 2018 · 5 months · monthly snapshot~Jun 2018 – ~Aug 2019 · 14 months · monthly snapshot~Aug 2019 – ~Apr 2020 · 8 months · monthly snapshot~Apr 2020 – ~May 2020 · 30 days · monthly snapshot~May 2020 – ~Jan 2021 · 8 months · monthly snapshot~Jan 2021 – ~Oct 2021 · 9 months · monthly snapshot~Oct 2021 – ~Dec 2021 · 2 months · monthly snapshot~Dec 2021 – ~Jun 2022 · 6 months · monthly snapshot~Jun 2022 – ~Sep 2022 · 3 months · monthly snapshot~Sep 2022 – ~Jul 2024 · 22 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – present · 10 months · monthly snapshot

Change History

15 versions recorded

  1. Sep 2025 — Present [monthly]

    Completed PHASE1

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE1

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1

  4. Sep 2022 — Jul 2024 [monthly]

    Completed PHASE1

  5. Jun 2022 — Sep 2022 [monthly]

    Completed PHASE1

    Status: Active Not Recruiting → Completed

▶ Show 10 earlier versions

  1. Dec 2021 — Jun 2022 [monthly]

    Active Not Recruiting PHASE1

  2. Oct 2021 — Dec 2021 [monthly]

    Active Not Recruiting PHASE1

    Status: Recruiting → Active Not Recruiting

  3. Jan 2021 — Oct 2021 [monthly]

    Recruiting PHASE1

    Status: Active Not Recruiting → Recruiting

  4. May 2020 — Jan 2021 [monthly]

    Active Not Recruiting PHASE1

    Status: Recruiting → Active Not Recruiting

  5. Apr 2020 — May 2020 [monthly]

    Recruiting PHASE1

  6. Aug 2019 — Apr 2020 [monthly]

    Recruiting PHASE1

  7. Jun 2018 — Aug 2019 [monthly]

    Recruiting PHASE1

  8. Jan 2018 — Jun 2018 [monthly]

    Recruiting PHASE1

  9. Feb 2017 — Jan 2018 [monthly]

    Recruiting PHASE1

  10. Jan 2017 — Feb 2017 [monthly]

    Recruiting PHASE1

    First recorded

Nov 2014

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Kyowa Kirin Pharmaceutical Development Ltd
Data source: Kyowa Kirin Co., Ltd.

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

Study Locations

Barcelona, Spain , Bergen, Norway , Haifa, Israel , Leeds, United Kingdom , Liverpool, United Kingdom , London, United Kingdom , Madrid, Spain , Murcia, Spain , Nottingham, United Kingdom , Odense, Denmark and 4 more locations