NS1209 and Lidocaine in Patients With Peripheral Neuropathic Pain

This study has been completed.

Sponsors and Collaborators:	Danish Pain Research Center NeuroSearch A/S
Information provided by:	Danish Pain Research Center
ClinicalTrials.gov Identifier:	NCT00258622

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 II

Drug Information available for: Lidocaine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	NS1209 and Lidocaine in Patients With Peripheral Neuropathic Pain: a Randomized, Double-Blind, Placebo-Controlled, Crossover Study

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

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

Danish Pain Research Center This link exits the ClinicalTrials.gov site

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

Keywords provided by Danish Pain Research Center:

Peripheral neuropathic pain
Neuropathic pain
Chronic pain

Study placed in the following topic categories:

Lidocaine
Pain

Additional relevant MeSH terms:

Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Depressants
Anesthetics
Cardiovascular Agents

Anti-Arrhythmia Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Pharmacologic Actions
Anesthetics, Local

ClinicalTrials.gov processed this record on January 14, 2009