MedTrace Logo

PK PD of the Enantiomers of Tramadol and O-desmethyltramadol in Elderly and Young Subjects

NCT02329561 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2014-12-31

No results posted yet for this study

Summary

This study evaluates the pharmacokinetics and pharmacodynamics of the enantiomers of tramadol and O-desmethyltramadol (ODM) in generally healthy young and elderly adults. Using a randomised, double-blind, crossover design, participants were administered a single 200mg tramadol extended-release tablet and placebo.

Conditions

Interventions

DRUG

Tramadol extended release 200 mg

Tramadol extended release 200 mg: Administration of a single 200mg tramadol extended-release tablet

BEHAVIORAL

CP/T

Subjects were evaluated for perception and tolerance of electrical current. An experimentally induced pain model utilizing electrical stimulation from the FDA approved Neurometer, as the painful stimulus was used to assess Current Perception Threshold and Pain Tolerance Threshold (CP/T) in young and elderly subjects following administration of tramadol and of placebo.

DRUG

Placebo

Administration of a single placebo tablet identical in appearance to a 200mg tramadol extended-release tablet

Sponsors & Collaborators

  • Labopharm Inc.

    collaborator INDUSTRY

  • MDS Pharma Services

    collaborator INDUSTRY

  • Université de Montréal

    lead OTHER

Principal Investigators

  • France Varin, BPharm, PhD · Université de Montréal

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2007-02-28
Completion
2007-02-28

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02329561 on ClinicalTrials.gov