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NS1209 and Lidocaine in Patients With Peripheral Neuropathic Pain

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00258622
First Posted: November 28, 2005
Last Update Posted: November 16, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
NeuroSearch A/S
Information provided by:
Danish Pain Research Center
  Purpose
Purpose: To evaluate the efficacy, tolerability and safety of NS1209 compared to lidocaine and placebo in patients with peripheral chronic neuropathic pain.

Condition Intervention Phase
Pain Drug: NS1209 Drug: Lidocaine Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: NS1209 and Lidocaine in Patients With Peripheral Neuropathic Pain: a Randomized, Double-Blind, Placebo-Controlled, Crossover Study

Resource links provided by NLM:


Further study details as provided by Danish Pain Research Center:

Primary Outcome Measures:
  • - Spontaneous ongoing pain intensity (VAS 0-100)

Secondary Outcome Measures:
  • 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)

Enrollment: 18
Study Start Date: November 2005
Study Completion Date: February 2007
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00258622


Locations
Denmark
Danish Pain Research Center, Aarhus University Hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
Danish Pain Research Center
NeuroSearch A/S
Investigators
Principal Investigator: Troels S Jensen, MD, PhD Danish Pain Research Center, Aarhus University Hospital
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00258622     History of Changes
Other Study ID Numbers: NS1209-008
First Submitted: November 24, 2005
First Posted: November 28, 2005
Last Update Posted: November 16, 2007
Last Verified: November 2007

Keywords provided by Danish Pain Research Center:
Peripheral neuropathic pain
Neuropathic pain
Chronic pain

Additional relevant MeSH terms:
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action