NS1209 and Lidocaine in Patients With Peripheral Neuropathic Pain

This study has been completed.
Sponsor:
Collaborator:
NeuroSearch A/S
Information provided by:
Danish Pain Research Center
ClinicalTrials.gov Identifier:
NCT00258622
First received: November 24, 2005
Last updated: November 15, 2007
Last verified: November 2007
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

ClinicalTrials.gov Identifier: NCT00258622     History of Changes
Other Study ID Numbers: NS1209-008
Study First Received: November 24, 2005
Last Updated: November 15, 2007
Health Authority: Denmark: Danish Medicines Agency

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
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2014