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Evaluation of the Antihyperalgesic Effect of Tapentadol in Two Human Experimental Models

NCT01615510 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2022-09-14

No results posted yet for this study

Summary

MOR-NRI like Tapentadol are expected to reduce signs and symptoms of central sensitisation besides effectively reducing pain intensity in pain. Human pain surrogate models can serve in this proof-of-concept study to further elucidate this assumption.

Conditions

  • Pain
  • Hyperalgesia
  • Allodynia

Interventions

DRUG

Tapentadol immediate release

100 mg, single administration

DRUG

placebo

placebo, single administration

Sponsors & Collaborators

  • University Hospital Schleswig-Holstein

    lead OTHER

Principal Investigators

  • Ralf Baron, Professor · Head of Division of Neurological Pain Research and Therapy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • Germany

Study Locations

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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 NCT01615510 on ClinicalTrials.gov