NCT01947920

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Aug 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

August 13, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 23, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

December 16, 2014

Status Verified

December 1, 2014

Enrollment Period

3 months

First QC Date

August 13, 2013

Last Update Submit

December 15, 2014

Conditions

Healthy

Keywords

HealthyPainTramadol hydrochlorideTramadol HClAnalgesicQT prolongationRWJ-26898-002

Outcome Measures

Primary Outcomes (1)

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

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

    Baseline, Days 1 through 4

Secondary Outcomes (3)

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

    Baseline, Day 1, Day 3 and Day 4

  • Change from baseline in pharmacokinetic parameters of tramadol and M1 metabolite

    Baseline, up to 72 hours after the 1st dose

  • Incidence and type of adverse events

    Baseline, till the end of study

Study Arms (3)

1: Tramadol HCl 200 mg daily or placebo

EXPERIMENTAL

Participants will receive one capsule of Tramadol hydrochloride (HCl) every 6 hours. Participants assigned to placebo will receive matching placebo capsules. A total of 9 doses will be administered.

Drug: Tramadol HCl, 50 mgDrug: Placebo

2: Tramadol HCl 400 mg daily or placebo

EXPERIMENTAL

Participants will recieve two capsules of Tramadol HCl every 6 hours. Participants assigned to placebo will receive matching placebo capsules. A total of 9 doses will be administered.

Drug: Tramadol HCl, 50 mgDrug: Placebo

3: Tramadol HCl 600 mg daily or placebo

EXPERIMENTAL

Participants will receive three capsules of Tramadol HCl every 6 hours. Participants assigned to placebo will receive matching placebo capsules. A total of 9 doses will be administered.

Drug: Tramadol HCl, 50 mgDrug: Placebo

Interventions

Tramadol HCl, 50 mgDRUG

50-mg overencapsulated tablet for oral administration

1: Tramadol HCl 200 mg daily or placebo2: Tramadol HCl 400 mg daily or placebo3: Tramadol HCl 600 mg daily or placebo
PlaceboDRUG

Size-matching capsules containing an appropriate inactive excipient

1: Tramadol HCl 200 mg daily or placebo2: Tramadol HCl 400 mg daily or placebo3: Tramadol HCl 600 mg daily or placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Overland Park, Kansas, United States

Location

MeSH Terms

Conditions

PainLong QT Syndrome

Interventions

Tramadol

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseaseHeart Defects, CongenitalCardiovascular AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPathologic Processes

Intervention Hierarchy (Ancestors)

CyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsDimethylaminesMethylaminesAminesLipids

Study Officials

  • Janssen Scientific Affairs, LLC Clinical trial

    Janssen Scientific Affairs, LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2013

First Posted

September 23, 2013

Study Start

August 1, 2013

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

December 16, 2014

Record last verified: 2014-12

Locations

US(1)