Back to resultsNS1209 and Lidocaine in Patients With Peripheral Neuropathic Pain
Primary Purpose
Pain
Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
NS1209
Lidocaine
Sponsored by
About this trial
This is an interventional treatment trial for Pain focused on measuring Peripheral neuropathic pain, Neuropathic pain, Chronic pain
Eligibility 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
Sites / Locations
- Danish Pain Research Center, Aarhus University Hospital
Outcomes
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)
Full Information
NCT ID
NCT00258622
First Posted
November 24, 2005
Last Updated
November 15, 2007
Sponsor
Danish Pain Research Center
Collaborators
NeuroSearch A/S
1. Study Identification
Unique Protocol Identification Number
NCT00258622
Brief Title
NS1209 and Lidocaine in Patients With Peripheral Neuropathic Pain
Official Title
NS1209 and Lidocaine in Patients With Peripheral Neuropathic Pain: a Randomized, Double-Blind, Placebo-Controlled, Crossover Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Danish Pain Research Center
Collaborators
NeuroSearch A/S
4. Oversight
5. Study Description
Brief Summary
Purpose: To evaluate the efficacy, tolerability and safety of NS1209 compared to lidocaine and placebo in patients with peripheral chronic neuropathic pain.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
Peripheral neuropathic pain, Neuropathic pain, Chronic pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
NS1209
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Primary Outcome Measure Information:
Title
- Spontaneous ongoing pain intensity (VAS 0-100)
Secondary Outcome Measure Information:
Title
Number of responders (at least 33% pain reduction)
Title
Effect on evoked allodynia (VAS 0-100)
Title
Pain relief for overall spontaneous pain (complete, good, moderate, slight, none or worse)
Title
Feeling of unpleasantness (VAS 0-100)
Title
Pain on movements (VAS 0-100)
Title
Daily pain (NSP 0-10)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Troels S Jensen, MD, PhD
Organizational Affiliation
Danish Pain Research Center, Aarhus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Danish Pain Research Center, Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
12. IPD Sharing Statement
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NS1209 and Lidocaine in Patients With Peripheral Neuropathic Pain
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