deltatrials
Completed PHASE3 INTERVENTIONAL 3-arm NCT03657810

A Controlled Study to Determine the Efficacy and Safety of CL-108 5 mg for Acute Pain and the Prevention of OINV

A Randomized, Double-Blind, Placebo- and Active-Controlled Study to Determine the Efficacy and Safety of CL-108 5 mg (Hydrocodone 5 mg/Acetaminophen 325 mg/Promethazine 12.5 mg) as a Treatment for Moderate-to-Severe Acute Pain and the Prevention of Opioid-Induced Nausea and Vomiting (OINV) Following Orthopedic Surgery

Sponsor: Charleston Laboratories, Inc

Updated 8 times since 2018 Last updated: Feb 24, 2023 Started: Aug 2, 2017 Primary completion: Apr 16, 2018 Completion: Nov 30, 2018
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Nausea and Pain and is currently completed. Charleston Laboratories, Inc leads this study, which shows 8 recorded versions since 2017 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Oct 2018 – ~Feb 2019 · 4 months · monthly snapshotActive Not Recruiting~Feb 2019 – ~Aug 2019 · 6 months · monthly snapshotCompleted~Aug 2019 – ~Jan 2021 · 17 months · monthly snapshotCompleted~Jan 2021 – ~Apr 2022 · 15 months · monthly snapshotCompleted~Apr 2022 – ~Apr 2023 · 12 months · monthly snapshotCompleted~Apr 2023 – ~Jul 2024 · 15 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 22 months · monthly snapshotCompleted

Change History

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

    Completed PHASE3

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  3. Apr 2023 — Jul 2024 [monthly]

    Completed PHASE3

  4. Apr 2022 — Apr 2023 [monthly]

    Completed PHASE3

  5. Jan 2021 — Apr 2022 [monthly]

    Completed PHASE3

Show 3 earlier versions
  1. Aug 2019 — Jan 2021 [monthly]

    Completed PHASE3

  2. Feb 2019 — Aug 2019 [monthly]

    Completed PHASE3

    Status: Active Not RecruitingCompleted

  3. Oct 2018 — Feb 2019 [monthly]

    Active Not Recruiting PHASE3

    First recorded

Aug 2017

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Charleston Laboratories, Inc
Data source: Charleston Laboratories, Inc

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