MedDataX Logo

NS1209 and Lidocaine in Patients With Peripheral Neuropathic Pain

NCT ID: NCT00258622

Last Updated: 2007-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2007-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Peripheral neuropathic pain Neuropathic pain Chronic pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

NS1209

Intervention Type DRUG

Lidocaine

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

NeuroSearch A/S

INDUSTRY

Sponsor Role collaborator

Danish Pain Research Center

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Troels S Jensen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Danish Pain Research Center, Aarhus University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Danish Pain Research Center, Aarhus University Hospital

Aarhus, , Denmark

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Denmark

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NS1209-008

Identifier Type: -

Identifier Source: org_study_id