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NS1209 and Lidocaine in Patients With Peripheral Neuropathic Pain

D

Danish Pain Research Center

Status and phase

Completed
Phase 2

Conditions

Pain

Treatments

Drug: Lidocaine
Drug: NS1209

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00258622
NS1209-008

Details and patient eligibility

About

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

Enrollment

18 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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