deltatrials
Completed PHASE1 INTERVENTIONAL 2-arm NCT03087786

Oral Mucosal Effects In Adult Smokers Associated With Two Nicotine Lozenge Formulations

Randomized, Parallel-Group, Assessor Blind Study To Evaluate Oral Mucosal Effects In Healthy Adult Smokers Associated With 3 Week Use Of Nicotine Bi-tartrate 4mg Mint Lozenges Relative To The Use Of Nicotine Polacrilex 4mg Mint Lozenges

Sponsor: Inflamax Research Incorporated

Conditions Safety Issues
Updated 8 times since 2017 Last updated: Jan 6, 2021 Started: Mar 21, 2017 Primary completion: Aug 13, 2017 Completion: Aug 13, 2017
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE1 trial investigates Safety Issues and is currently completed. Inflamax Research Incorporated 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

~Apr 2017 – ~Oct 2017 · 6 months · monthly snapshotRecruiting~Oct 2017 – ~Jun 2018 · 8 months · monthly snapshotActive Not Recruiting~Jun 2018 – ~Oct 2019 · 16 months · monthly snapshotActive Not Recruiting~Oct 2019 – ~Jan 2021 · 15 months · monthly snapshotUnknown Status~Jan 2021 – ~Feb 2021 · 31 days · monthly snapshotUnknown Status~Feb 2021 – ~Jul 2024 · 41 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 PHASE1

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1

  3. Feb 2021 — Jul 2024 [monthly]

    Completed PHASE1

    Status: Unknown StatusCompleted · Phase: PHASE3PHASE1

  4. Jan 2021 — Feb 2021 [monthly]

    Unknown Status PHASE3

  5. Oct 2019 — Jan 2021 [monthly]

    Unknown Status PHASE3

    Status: Active Not RecruitingUnknown Status

Show 3 earlier versions
  1. Jun 2018 — Oct 2019 [monthly]

    Active Not Recruiting PHASE3

  2. Oct 2017 — Jun 2018 [monthly]

    Active Not Recruiting PHASE3

    Status: RecruitingActive Not Recruiting

  3. Apr 2017 — Oct 2017 [monthly]

    Recruiting PHASE3

    First recorded

Mar 2017

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Inflamax Research Incorporated
  • Niconovum USA
Data source: Niconovum USA

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

Study Locations