deltatrials
Completed PHASE1 INTERVENTIONAL 3-arm NCT03312777

Omnitram Pharmacokinetic and Analgesic Study Following CY2D6 Inhibition With Paroxetine In Healthy Volunteers

A Phase 1b, Double-Blind, Randomized, Placebo-Controlled, Three Segment Cross-Over Study Investigating Oral Steady-State Pharmacokinetics And Hypoalgesic Effect Of 20 Mg Omnitram And 50 Mg Tramadol In Normal Human Subjects Made Cyp2d6 Deficient By Paroxetine

Sponsor: DF/Net Rearch

Conditions Pain
Updated 7 times since 2017 Last updated: Dec 26, 2017 Started: Oct 31, 2017 Primary completion: Dec 15, 2017 Completion: Dec 22, 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 Pain and is currently completed. DF/Net Rearch leads this study, which shows 7 recorded versions since 2017 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Nov 2017 – ~Dec 2017 · 30 days · monthly snapshotRecruiting~Dec 2017 – ~Jan 2018 · 31 days · monthly snapshotRecruiting~Jan 2018 – ~Jun 2018 · 5 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 22 months · monthly snapshotCompleted

Change History

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

    Completed PHASE1

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1

  3. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE1

  4. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE1

  5. Jan 2018 — Jun 2018 [monthly]

    Completed PHASE1

    Status: RecruitingCompleted

Show 2 earlier versions
  1. Dec 2017 — Jan 2018 [monthly]

    Recruiting PHASE1

  2. Nov 2017 — Dec 2017 [monthly]

    Recruiting PHASE1

    First recorded

Oct 2017

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • DF/Net Rearch
  • ITT Research Institute
  • PRA Health Sciences
  • Syntrix Biosystems, Inc.
Data source: Syntrix Biosystems, Inc.

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