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Completed

NCT Number: NCT01947920

A Dose Ranging Escalation Study of Tramadol Hydrochloride in Healthy Volunteers

The purpose of this study is to determine the safety and tolerability profile of tramadol hydrochloride (HCl) given as oral doses every 6 hours, within the range of dosages supported by currently available toxicology and clinical data (200 mg to 600 mg per day).

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Key information

Conditions

Healthy Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Long QT Syndrome Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Overland Park, Kansas, United States

About this study

This is a randomized (study drug assigned by chance), sequential-cohort (time lagged), double-blind (neither the participant or the study doctor will know the name of the assigned treatment), parallel-group, placebo-controlled, 3-arm (participants will be assigned to 1 of 3 treatment groups), single-center, Phase 1 study of multiple ascending doses of tramadol HCl in healthy adult volunteers. Thirty participants (15 men and 15 women) will be sequentially assigned to 1 of 3 treatment groups of 10 subjects each (5 men and 5 women). Participants in each treatment group will receive a total of 9 oral doses (one every 6 hours) of tramadol HCl or placebo, in the ratio of 4:1. The study includes a screening phase and a double-blind treatment phase. The treatment phase will consist of 3 treatment periods separated by a 5-day safety review period before the next ascending dose of study drug is administered to the next group. Participants in each group will be confined to the study center for a total of 5 days, the total duration of each subject's participation will be up to 33 days, including the screening phase. The total duration of the study (completion of all 3 treatment cohorts) will be up-to-approximately 2 months.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • body mass index between 18 and 30 kg/m², inclusive
  • body weight not less than 50 kg
  • have a normal electroencephalogram under basic and stimulated conditions
  • have a 12-lead ECG that is consistent with normal cardiac conduction and function
  • have not used any tobacco products (eg, cigarettes, cigars, chewing tobacco, gum, or patch) for at least 6 months before first study drug administration

Exclusion criteria

  • any personal or family history of epileptic seizures or convulsions
  • have suffered from head trauma with loss of consciousness -have suffered from central nervous system infection
  • have suffered from loss of consciousness of unknown origin
  • drowning or sudden infant death syndrome in a first degree relative

Treatment and study plan

Tramadol HCl, 50 mg

Drug

50-mg overencapsulated tablet for oral administration

Placebo

Drug

Size-matching capsules containing an appropriate inactive excipient

Primary outcomes

  1. Change from baseline in vital signs and other parameters as a measure of safety and tolerability of tramadol

    Time frame: Baseline, Days 1 through 4

    Changes in clinical laboratory results, vital signs, psycopharmacologic status (Richmond Agitation-Sedation Scale (RASS), and physical examination.

Secondary outcomes

  1. Change from baseline in time-matched electrocardiogram (ECG) measurements

    Time frame: Baseline, Day 1, Day 3 and Day 4

    ECG will detect abnormal changes from baseline in cardiac depolarization/repolarization.

  2. Change from baseline in pharmacokinetic parameters of tramadol and M1 metabolite

    Time frame: Baseline, up to 72 hours after the 1st dose

    Determination of concentrations of tramadol and M1 metabolite pharmacokinetic parameters in venous plasma.

  3. Incidence and type of adverse events

    Time frame: Baseline, till the end of study

Sponsors and collaborators

Lead sponsor

Janssen Scientific Affairs, LLC

Industry

Collaborators

  • Bausch Health Americas, Inc.
  • Cipher Pharmaceuticals Inc.

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics Following Multiple Ascending Doses of Tramadol Hydrochloride in Healthy Male and Female Subjects

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Sep 23, 2013
Registry last updated
Dec 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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