NS1209 and Lidocaine in Patients With Peripheral Neuropathic Pain

November 15, 2007 updated by: Danish Pain Research Center

NS1209 and Lidocaine in Patients With Peripheral Neuropathic Pain: a Randomized, Double-Blind, Placebo-Controlled, Crossover Study

Purpose: To evaluate the efficacy, tolerability and safety of NS1209 compared to lidocaine and placebo in patients with peripheral chronic neuropathic pain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Danish Pain Research Center, Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age >18 years
  • Neuropathic pain and allodynia after a peripheral nerve injury (VAS >= 4)

Exclusion Criteria:

  • Patients who cannot cooperate and do no understand Danish
  • Fertile women
  • Clinically significant abnormality or disease
  • Drug and alcohol abuse
  • Clinically abnormal ECG
  • Hypersensitivity to any of the treatments
  • Patients in treatment with cimetedin, antidepressants, antipsychotics, antiepileptics except gabapentin, anticoagulants, Na channel blockers and beta blockers
  • Patients who have previously been treated in a NS1209 study
  • Patients treated with an investigational drug

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
- Spontaneous ongoing pain intensity (VAS 0-100)

Secondary Outcome Measures

Outcome Measure
Number of responders (at least 33% pain reduction)
Effect on evoked allodynia (VAS 0-100)
Pain relief for overall spontaneous pain (complete, good, moderate, slight, none or worse)
Feeling of unpleasantness (VAS 0-100)
Pain on movements (VAS 0-100)
Daily pain (NSP 0-10)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Danish Pain Research Center

Collaborators

NeuroSearch A/S

Investigators

  • Principal Investigator: Troels S Jensen, MD, PhD, Danish Pain Research Center, Aarhus University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Study Completion (Actual)

February 1, 2007

Study Registration Dates

First Submitted

November 24, 2005

First Submitted That Met QC Criteria

November 24, 2005

First Posted (Estimate)

November 28, 2005

Study Record Updates

Last Update Posted (Estimate)

November 16, 2007

Last Update Submitted That Met QC Criteria

November 15, 2007

Last Verified

November 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NS1209-008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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