NCT00258622

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_2 pain

Timeline
Completed

Started Nov 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

November 24, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 28, 2005

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
Last Updated

November 16, 2007

Status Verified

November 1, 2007

First QC Date

November 24, 2005

Last Update Submit

November 15, 2007

Conditions

Pain

Keywords

Peripheral neuropathic painNeuropathic painChronic pain

Outcome Measures

Primary Outcomes (1)

  • - Spontaneous ongoing pain intensity (VAS 0-100)

Secondary Outcomes (6)

  • 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)

  • +1 more secondary outcomes

Interventions

NS1209DRUG
LidocaineDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>18 years
  • Neuropathic pain and allodynia after a peripheral nerve injury (VAS \>= 4)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Danish Pain Research Center, Aarhus University Hospital

Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

PainNeuralgiaChronic Pain

Interventions

SPD 502Lidocaine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Troels S Jensen, MD, PhD

    Danish Pain Research Center, Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 24, 2005

First Posted

November 28, 2005

Study Start

November 1, 2005

Study Completion

February 1, 2007

Last Updated

November 16, 2007

Record last verified: 2007-11

Locations

DK(1)