CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 35 enrolled
Drug / intervention
Tramadol extended release 200 mg +2 moredrug
Likely dose
Tramadol extended release 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02329561
NCT02329561Phase 1Completed
CompareCT.gov

Comparative, Randomized, Double-Blind, Single-Dose, 2-way Crossover Study to Evaluate the Pharmacokinetics and Analgesic Effect of Labopharm Tramadol Contramid® OAD 200 mg Tablets or Placebo in Healthy Young and Elderly Adult Volunteers

Université de Montréal·interventional·Posted Dec 31, 2014·Updated Dec 31, 2014

In Brief

A Phase 1 clinical trial evaluating Tramadol extended release 200 mg, CP/T, and 1 other intervention for Aging and Pain. Completed, enrolled 35 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAging, Pain
Countries--
CollaboratorsLabopharm Inc., MDS Pharma Services

Timeline

Phase 1CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 31, 2014
Enrollment StartJan 1, 2007
Primary CompletionFeb 1, 2007
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 11.5 years ago

Interventions

Tramadol extended release 200 mgdrug

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

CP/Tbehavioral

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.

Placebodrug

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