Working… Menu
Trial record 26 of 119 for:    "Neuromuscular Disease" | "Lidocaine"

NS1209 and Lidocaine in Patients With Peripheral Neuropathic Pain

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. Identifier: NCT00258622
Recruitment Status : Completed
First Posted : November 28, 2005
Last Update Posted : November 16, 2007
NeuroSearch A/S
Information provided by:
Danish Pain Research Center

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

Condition or disease Intervention/treatment Phase
Pain Drug: NS1209 Drug: Lidocaine Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
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
Study Start Date : November 2005
Actual Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

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

Secondary Outcome Measures :
  1. Number of responders (at least 33% pain reduction)
  2. Effect on evoked allodynia (VAS 0-100)
  3. Pain relief for overall spontaneous pain (complete, good, moderate, slight, none or worse)
  4. Feeling of unpleasantness (VAS 0-100)
  5. Pain on movements (VAS 0-100)
  6. Daily pain (NSP 0-10)

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.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00258622

Layout table for location information
Danish Pain Research Center, Aarhus University Hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
Danish Pain Research Center
NeuroSearch A/S
Layout table for investigator information
Principal Investigator: Troels S Jensen, MD, PhD Danish Pain Research Center, Aarhus University Hospital

Additional Information:
Layout table for additonal information Identifier: NCT00258622     History of Changes
Other Study ID Numbers: NS1209-008
First Posted: November 28, 2005    Key Record Dates
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:
Layout table for MeSH terms
Neuromuscular Diseases
Peripheral Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Anesthetics, Local
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