Skip to main content
OpenTrials
Completed

NCT Number: NCT00258622

NS1209 and Lidocaine in Patients With Peripheral Neuropathic Pain

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pain Chronic Pain Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Danish Pain Research Center, Aarhus University Hospital

Aarhus, 8000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NS1209

Drug

Lidocaine

Drug

Primary outcomes

  1. - Spontaneous ongoing pain intensity (VAS 0-100)

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Danish Pain Research Center

Other

Collaborators

  • NeuroSearch A/S

Registry information

Official study title

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

Important dates

Study start
2005
Study completion
2007
First posted
Nov 28, 2005
Registry last updated
Nov 16, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.