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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00258622 |
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Date of registration:
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24/11/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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NS1209 and Lidocaine in Patients With Peripheral Neuropathic Pain
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Scientific title:
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NS1209 and Lidocaine in Patients With Peripheral Neuropathic Pain: a Randomized, Double-Blind, Placebo-Controlled, Crossover Study |
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Date of first enrolment:
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November 2005 |
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Target sample size:
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18 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00258622 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Troels S Jensen, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Danish Pain Research Center, Aarhus University Hospital |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Pain
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Intervention(s)
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Drug: NS1209
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Drug: Lidocaine
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Primary Outcome(s)
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- Spontaneous ongoing pain intensity (VAS 0-100)
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Secondary Outcome(s)
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Feeling of unpleasantness (VAS 0-100)
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Effect on evoked allodynia (VAS 0-100)
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Pain relief for overall spontaneous pain (complete, good, moderate, slight, none or worse)
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Pain on movements (VAS 0-100)
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Daily pain (NSP 0-10)
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Number of responders (at least 33% pain reduction)
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Secondary ID(s)
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NS1209-008
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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