Completed PHASE1 INTERVENTIONAL 4-arm NCT02307864

Study to Evaluate the Effects of Tramadol Hydrochloride on Cardiac Repolarization in Healthy Participants

A Randomized, Double-Blind, Placebo- and Positive-Controlled, Multiple Dose, Four Way Crossover Study to Evaluate the Effects of Tramadol Hydrochloride on Cardiac Repolarization in Healthy Subjects at Therapeutic and Supratherapeutic Dose Levels

Sponsor: Bausch Health Americas, Inc.

Conditions Healthy

Interventions Moxifloxacin 400 mg Moxifloxacin Placebo Tramadol HCl Tramadol HCl Placebo

Updated 8 times since 2017 Last updated: Aug 27, 2018 Started: Dec 4, 2014 Primary completion: Aug 22, 2015 Completion: Aug 27, 2015

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 Healthy and is currently completed. Bausch Health Americas, Inc. leads this study, which shows 8 recorded versions since 2014 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

Change History

8 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE1
Jul 2024 — Sep 2024 [monthly]

Completed PHASE1
Jan 2021 — Jul 2024 [monthly]

Completed PHASE1
Jun 2019 — Jan 2021 [monthly]

Completed PHASE1
Sep 2018 — Jun 2019 [monthly]

Completed PHASE1

▶ Show 3 earlier versions

Jun 2018 — Sep 2018 [monthly]

Completed PHASE1
Feb 2017 — Jun 2018 [monthly]

Completed PHASE1
Jan 2017 — Feb 2017 [monthly]

Completed PHASE1

First recorded

Dec 2014

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Bausch Health Americas, Inc.
Cipher Pharmaceuticals Inc.
Janssen Scientific Affairs, LLC

Data source: Janssen Scientific Affairs, LLC

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

Study Locations

• Overland Park, United States