PainPhase 2NCT00258622
NS1209 and Lidocaine in Patients With Peripheral Neuropathic Pain
A Phase 2 study testing NS1209 and Lidocaine in people with Pain, run by Danish Pain Research Center at 1 site in Denmark.
Trial summary
Purpose: To evaluate the efficacy, tolerability and safety of NS1209 compared to lidocaine and placebo in patients with peripheral chronic neuropathic pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- NS1209 and Lidocaine
- How many people
- 18 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2005to Feb 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years
- Neuropathic pain and allodynia after a peripheral nerve injury (VAS >= 4)
Who cannot join
- 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
Show all 9Show fewer
- 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 locations and contacts
1 site in 1 country.
Denmark1 site
Danish Pain Research Center, Aarhus University Hospital
Aarhus, 8000
About this study
Official title: NS1209 and Lidocaine in Patients With Peripheral Neuropathic Pain: a Randomized, Double-Blind, Placebo-Controlled, Crossover Study
Purpose: To evaluate the efficacy, tolerability and safety of NS1209 compared to lidocaine and placebo in patients with peripheral chronic neuropathic pain.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NS1209Drug
LidocaineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
- 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)
Daily pain (NSP 0-10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2005 (estimated)
- Study startNov 2005
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish Pain Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- NeuroSearch A/S
- Investigators
- Troels S Jensen, MD, PhD, Principal investigator, Danish Pain Research Center, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00258622
- Sponsor's protocol ID
- NS1209-008
- Status last verified
- Nov 2007
- First submitted
- 24 Nov 2005
- Last updated
- 16 Nov 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NS1209 and Lidocaine in Patients With Peripheral Neuropathic Pain: a Randomized, Double-Blind, Placebo-Controlled, Crossover Study
- ClinicalTrials.gov ID
- NCT00258622
- Acronym / sponsor ID
- NS1209-008
- Conditions
- Pain
- Keywords
- Peripheral neuropathic pain, Neuropathic pain, Chronic pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Danish Pain Research CenterUniversity, hospital or other
- Collaborators
- NeuroSearch A/S
- Study start
- Nov 2005
- Study completion
- Feb 2007 (actual)
- First posted
- 28 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose: To evaluate the efficacy, tolerability and safety of NS1209 compared to lidocaine and placebo in patients with peripheral chronic neuropathic pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age >18 years
- Neuropathic pain and allodynia after a peripheral nerve injury (VAS >= 4)
Key exclusion criteria (9 listed)
- Patients who cannot cooperate and do no understand Danish
- Fertile women
- Clinically significant abnormality or disease
- Drug and alcohol abuse
- Clinically abnormal ECG
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NS1209 | Drug | – |
| Lidocaine | Drug | – |
Primary outcome
- Spontaneous ongoing pain intensity (VAS 0-100)
6 secondary outcomes
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Troels S Jensen, MD, PhD principal investigator
Danish Pain Research Center, Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NS1209 and Lidocaine in people with Pain, run by Danish Pain Research Center at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
- Spontaneous ongoing pain intensity (VAS 0-100). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2007.