HyperalgesiaPhase 1NCT00279032
GW406381 In Patients With Peripheral Nerve Injury
A Phase 1 study testing GW406381 in people with Hyperalgesia and Neurodynia, run by GlaxoSmithKline at 5 sites in United Kingdom.
Trial summary
The findings from preclinical animal models confirm the peripheral anti-inflammatory/analgesic activity of GW406381 and also suggest contribution of a central site of action to the anti-hyperalgesic efficacy that may not be shared by other COX-2 inhibitors. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hyperalgesia, Neurodynia, Pain
- What is being tested?
- GW406381
- How many people
- 40 participants
- Where
- 5 sitesUnited Kingdom
- Study dates
- Sep 2003to not given
- Phase
- Phase 1
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Baseline average daily Pain Score of greater than or equal to 4 (averaged over the 7 days prior to Treatment Visit 1), as reported on the 11 point pain intensity numerical rating scale.
- Subjects on medications for neuropathic pain or received nerve blocks for neuropathic pain.
Who cannot join
- Known history of hypersensitivity or intolerance to acetaminophen, paracetamol, aspirin, COX-2 inhibitors or NSAIDs.
- Subject is unable to discontinue NSAIDs or COX-2 inhibitors (except aspirin as a cardioprotective; certain doses apply), topical lidocaine and topical capsaicin for the treatment of pain for the period prior to randomization and for the duration of the study.
- Subject is unable to refrain from sedative use during the study (benzodiazepines prescribed as hypnotic sleep agents allowed).
- Subject is unable to refrain from nerve blocks for 4 weeks prior to randomisation and during the study.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United Kingdom5 sites
GSK Investigational Site
Glasgow, Lanarkshire, G12 0YN
GSK Investigational Site
Leicester, Leicestershire, LE1 5WW
GSK Investigational Site
Liverpool, Lancashire, L9 7AL
GSK Investigational Site
London, W12 0NN
GSK Investigational Site
Solihull, West Midlands, B91 2JL
About this study
Official title: A Randomised, Placebo-Controlled, Double-Blind, Parallel Group Study to Investigate the Effects of Chronic Dose Oral GW406381 on Pain and Areas of Hyperalgesia and Allodynia in Patients With Peripheral Nerve Injury as a Result of Trauma or Surgery.
The findings from preclinical animal models confirm the peripheral anti-inflammatory/analgesic activity of GW406381 and also suggest contribution of a central site of action to the anti-hyperalgesic efficacy that may not be shared by other COX-2 inhibitors. A central action is consistent with distribution of GW406381 into the CNS in animals. Furthermore, preliminary data from a positron emission tomography study in which 6 healthy male volunteers received a tracer dose of 11C labelled GW406381 indicate that GW406381 is rapidly absorbed into the central nervous system in man.
- Conditions
- Hyperalgesia, Neurodynia, Pain, Trauma
- Being tested
- GW406381
- Keywords
- GW406381, peripheral nerve injury, patients, allodynia, hyperalgesia, randomised, placebo-controlled
- Medical subject headings
- Hyperalgesia, Neuralgia, Pain, Wounds and Injuries, Peripheral Nerve Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GW406381Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the effect of chronic oral dosing (21 days) of GW406381 compared to placebo, on pain in patients with peripheral nerve injury
Secondary outcomes (1)
To investigate the effect of 21 days oral dosing of GW406381 on thermal hyperalgesia, dynamic allodynia and static mechanical hyperalgesia in patients with peripheral nerve injury.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2006 (estimated)
- Study startSep 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperalgesiaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- GSK Clinical Trials, MD, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00279032
- Sponsor's protocol ID
- CXA10006
- Status last verified
- Feb 2009
- First submitted
- 17 Jan 2006
- Last updated
- 23 Feb 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Placebo-Controlled, Double-Blind, Parallel Group Study to Investigate the Effects of Chronic Dose Oral GW406381 on Pain and Areas of Hyperalgesia and Allodynia in Patients With Peripheral Nerve Injury as a Result of Trauma or Surgery.
- ClinicalTrials.gov ID
- NCT00279032
- Acronym / sponsor ID
- CXA10006
- Conditions
- Hyperalgesia, Neurodynia, Pain, Trauma
- Keywords
- GW406381, peripheral nerve injury, patients, allodynia, hyperalgesia, randomised, placebo-controlled
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Sep 2003
- First posted
- 19 Jan 2006 (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.
The findings from preclinical animal models confirm the peripheral anti-inflammatory/analgesic activity of GW406381 and also suggest contribution of a central site of action to the anti-hyperalgesic efficacy that may not be shared by other COX-2 inhibitors. A central action is consistent with distribution of GW406381 into the CNS in animals. Furthermore, preliminary data from a positron emission tomography study in which 6 healthy male volunteers received a tracer dose of 11C labelled GW406381 indicate that GW406381 is rapidly absorbed into the central nervous system in man.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Baseline average daily Pain Score of greater than or equal to 4 (averaged over the 7 days prior to Treatment Visit 1), as reported on the 11 point pain intensity numerical rating scale.
- Subjects on medications for neuropathic pain or received nerve blocks for neuropathic pain.
Key exclusion criteria (4 listed)
- Known history of hypersensitivity or intolerance to acetaminophen, paracetamol, aspirin, COX-2 inhibitors or NSAIDs.
- Subject is unable to discontinue NSAIDs or COX-2 inhibitors (except aspirin as a cardioprotective; certain doses apply), topical lidocaine and topical capsaicin for the treatment of pain for the period prior to randomization and for the duration of the study.
- Subject is unable to refrain from sedative use during the study (benzodiazepines prescribed as hypnotic sleep agents allowed).
- Subject is unable to refrain from nerve blocks for 4 weeks prior to randomisation and during the study.
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 |
|---|---|---|
| GW406381 | Drug | – |
Primary outcome
To investigate the effect of chronic oral dosing (21 days) of GW406381 compared to placebo, on pain in patients with peripheral nerve injury
1 secondary outcome
To investigate the effect of 21 days oral dosing of GW406381 on thermal hyperalgesia, dynamic allodynia and static mechanical hyperalgesia in patients with peripheral nerve injury.
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 23 Feb 2009.
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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.
GSK Clinical Trials, MD study director
GlaxoSmithKline
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GW406381 in people with Hyperalgesia and Neurodynia, run by GlaxoSmithKline at 5 sites in United Kingdom.
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 4 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 23 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United Kingdom. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
To investigate the effect of chronic oral dosing (21 days) of GW406381 compared to placebo, on pain in patients with peripheral nerve injury. 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 23 Feb 2009.