deltatrials
Completed PHASE2 INTERVENTIONAL 2-arm NCT03201393

Low-Dose Naltrexone and Acetaminophen Combination in the Treatment of Chronic Low Back Pain (ANODYNE-4)

A Single Site, Phase 2B, Randomized, Double-Blind, Study to Assess the Efficacy, Safety, and Tolerability of Low-Dose Naltrexone and Acetaminophen Combination vs. Placebo in the Treatment of Chronic Low Back Pain (ANODYNE-4)

Sponsor: Allodynic Therapeutics, Inc

Updated 12 times since 2017 Last updated: Apr 11, 2021 Started: Aug 15, 2017 Primary completion: Jul 26, 2018 Completion: Jul 26, 2018
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE2 trial investigates Chronic Low Back Pain and Lumbar Radiculopathy and is currently completed. Allodynic Therapeutics, Inc leads this study, which shows 12 recorded versions since 2017 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Jul 2017 – ~Aug 2017 · 31 days · monthly snapshotNot Yet Recruiting~Aug 2017 – ~Sep 2017 · 31 days · monthly snapshotNot Yet Recruiting~Sep 2017 – ~Nov 2017 · 2 months · monthly snapshotRecruiting~Nov 2017 – ~May 2018 · 6 months · monthly snapshotRecruiting~May 2018 – ~Jun 2018 · 31 days · monthly snapshotActive Not Recruiting~Jun 2018 – ~Jul 2019 · 13 months · monthly snapshotActive Not Recruiting~Jul 2019 – ~Jan 2021 · 18 months · monthly snapshotCompleted~Jan 2021 – ~May 2021 · 4 months · monthly snapshotCompleted~May 2021 – ~Jan 2024 · 32 months · monthly snapshotCompleted~Jan 2024 – ~Jul 2024 · 6 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 22 months · monthly snapshotCompleted

Change History

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

    Completed PHASE2

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  3. Jan 2024 — Jul 2024 [monthly]

    Completed PHASE2

  4. May 2021 — Jan 2024 [monthly]

    Completed PHASE2

    Phase: PHASE2_PHASE3PHASE2

  5. Jan 2021 — May 2021 [monthly]

    Completed PHASE2_PHASE3

Show 7 earlier versions
  1. Jul 2019 — Jan 2021 [monthly]

    Completed PHASE2_PHASE3

    Status: Active Not RecruitingCompleted

  2. Jun 2018 — Jul 2019 [monthly]

    Active Not Recruiting PHASE2_PHASE3

  3. May 2018 — Jun 2018 [monthly]

    Active Not Recruiting PHASE2_PHASE3

    Status: RecruitingActive Not Recruiting

  4. Nov 2017 — May 2018 [monthly]

    Recruiting PHASE2_PHASE3

  5. Sep 2017 — Nov 2017 [monthly]

    Recruiting PHASE2_PHASE3

    Status: Not Yet RecruitingRecruiting

  6. Aug 2017 — Sep 2017 [monthly]

    Not Yet Recruiting PHASE2_PHASE3

  7. Jul 2017 — Aug 2017 [monthly]

    Not Yet Recruiting PHASE2_PHASE3

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Allodynic Therapeutics, Inc
Data source: Allodynic Therapeutics, Inc

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

Study Locations