deltatrials
Terminated PHASE3 INTERVENTIONAL 2-arm NCT01696643

Safety Study of CB-5945 for the Treatment of Opioid-Induced Constipation

Phase 3 Study to Evaluate the Long-Term Safety and Tolerability of CB-5945 for the Treatment of Opioid-Induced Constipation in Adults Taking Opioid Therapy for Chronic Non-Cancer Pain

Sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Interventions CB-5945 Placebo
Updated 13 times since 2017 Last updated: Oct 17, 2018 Started: Oct 12, 2012 Primary completion: Jul 21, 2014 Completion: Jul 21, 2014
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

A review of blinded data indicates that the number of participant exposures needed to reach ICH standards has been met

Listed as NCT01696643, this PHASE3 trial focuses on Opioid-Induced Constipation and remains terminated or withdrawn. Sponsored by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA), it has been updated 13 times since 2012, 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 – ~Aug 2017 · 6 months · monthly snapshot~Aug 2017 – ~May 2018 · 9 months · monthly snapshot~May 2018 – ~Jun 2018 · 31 days · monthly snapshot~Jun 2018 – ~Sep 2018 · 3 months · monthly snapshot~Sep 2018 – ~Dec 2018 · 3 months · monthly snapshot~Dec 2018 – ~Nov 2020 · 23 months · monthly snapshot~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshot~Jan 2021 – ~Dec 2021 · 11 months · monthly snapshot~Dec 2021 – ~Jan 2024 · 25 months · monthly snapshot~Jan 2024 – ~Jul 2024 · 6 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – present · 21 months · monthly snapshot

Change History

13 versions recorded
  1. Sep 2024 — Present [monthly]

    Terminated PHASE3

  2. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE3

  3. Jan 2024 — Jul 2024 [monthly]

    Terminated PHASE3

  4. Dec 2021 — Jan 2024 [monthly]

    Terminated PHASE3

  5. Jan 2021 — Dec 2021 [monthly]

    Terminated PHASE3

Show 8 earlier versions
  1. Nov 2020 — Jan 2021 [monthly]

    Terminated PHASE3

  2. Dec 2018 — Nov 2020 [monthly]

    Terminated PHASE3

  3. Sep 2018 — Dec 2018 [monthly]

    Terminated PHASE3

  4. Jun 2018 — Sep 2018 [monthly]

    Terminated PHASE3

  5. May 2018 — Jun 2018 [monthly]

    Terminated PHASE3

  6. Aug 2017 — May 2018 [monthly]

    Terminated PHASE3

  7. Feb 2017 — Aug 2017 [monthly]

    Terminated PHASE3

  8. Jan 2017 — Feb 2017 [monthly]

    Terminated PHASE3

    First recorded

Oct 2012

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Data source: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

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

Study Locations

No location information available.