NS1209 and Lidocaine in Patients With Peripheral Neuropathic Pain

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00258622
• Other study ID #: NS1209-008
• Status: Completed
• Phase: Phase 2
• First received: November 24, 2005
• Last updated: November 15, 2007
• Start date: November 2005
• Est. completion date: February 2007

Study information

• Verified date: November 2007
• Source: Danish Pain Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neuralgia
• Pain

Intervention

Drug:
• NS1209

• Lidocaine

Locations

Country	Name	City	State
Denmark	Danish Pain Research Center, Aarhus University Hospital	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
Danish Pain Research Center	NeuroSearch A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	- Spontaneous ongoing pain intensity (VAS 0-100)
Secondary	Number of responders (at least 33% pain reduction)
Secondary	Effect on evoked allodynia (VAS 0-100)
Secondary	Pain relief for overall spontaneous pain (complete, good, moderate, slight, none or worse)
Secondary	Feeling of unpleasantness (VAS 0-100)
Secondary	Pain on movements (VAS 0-100)
Secondary	Daily pain (NSP 0-10)

External Links

•   Danish Pain Research Center