Neuropathic PainPhase 2NCT00376454
The Study of GW493838, an Adenosine A1 Agonist, in Peripheral Neuropathic Pain
A Phase 2 study testing GW493838 in people with Neuropathic Pain, run by GlaxoSmithKline at 32 sites in United States.
Trial summary
The purpose of this study was to determine the analgesic effect of GW493838 in patients with post-herpetic neuralgia or peripheral nerve injury caused by trauma or surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Neuropathic Pain
- What is being tested?
- GW493838
- How many people
- 113 participants
- Where
- 32 sitesUnited States
- Study dates
- Nov 2002to Jun 2003
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- discontinue agents for the treatment of neuropathic pain
- unable to refrain from alcohol and sedative use during the study
- confounding chronic pain which could not be differentiated from the peripheral neuropathic pain under study
- intractable pain of unknown origin or active infection in the area of nerve injury.
- clinically significant medical history or abnormality found on physical examination, laboratory assessment or ECG at Screening or Baseline
- severe asthma that has required oral corticosteroid use in the last 12 months or the subject had severe asthma that required, at anytime, hospitalization or mechanical ventilation support.
Show all 14Show fewer
- clinical evidence of major depression (by medical history) except those subjects controlled by SSRIs.
- a known allergy or hypersensitivity to any of the investigational products (including rescue analgesia- acetaminophen), or pharmacological class of the investigational product (i.e. adenosine) and/or investigational product excipients.
- a clinically significant abuse of substances, defined as: Patterns of substance intake consistent with disruption of normal function in society; Past or current impairment of organ function reasonably related to substance intake; Any indication of difficulty in abstaining from substances for the duration of the study.
- had previously participated in a clinical study during the past 30 days in which the subject was exposed to an investigational or non-investigational drug or device
- currently participating in another clinical study in which the subject was exposed to an investigational or non-investigational drug or device
- prior blood reduction (450 mL or more) during the previous 30 days
- at risk of non-compliance
- a woman of childbearing potential or a woman who was lactating.
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
United States32 sites
GSK Clinical Trials Call Center
Albany, New York, 12205
GSK Clinical Trials Call Center
Altoona, Pennsylvania, 16601
GSK Clinical Trials Call Center
Asheville, North Carolina, 28803
GSK Clinical Trials Call Center
Boston, Massachusetts, 02115
GSK Clinical Trials Call Center
Boulder, Colorado, 80304
GSK Clinical Trials Call Center
Covington, Louisiana, 70433
GSK Clinical Trials Call Center
Duncansville, Pennsylvania, 16635
GSK Clinical Trials Call Center
Evansville, Indiana, 47712
GSK Clinical Trials Call Center
Fort Lauderdale, Florida, 33308
GSK Clinical Trials Call Center
Fort Myers, Florida, 33916
GSK Clinical Trials Call Center
Henderson, Nevada, 89052
GSK Clinical Trials Call Center
Hot Springs, Arizona, 71913
GSK Clinical Trials Call Center
Huntsville, Alabama, 35801
GSK Clinical Trials Call Center
La Jolla, California, 92037
GSK Clinical Trials Call Center
Lebanon, New Hampshire, 03766
GSK Clinical Trials Call Center
Lexington, Kentucky, 40503
GSK Clinical Trials Call Center
Little Rock, Arkansas, 72205
GSK Clinical Trials Call Center
Louisville, Kentucky, 40202
GSK Clinical Trials Call Center
Louisville, Kentucky, 40205
GSK Clinical Trials Call Center
Madison, Wisconsin, 53792
GSK Clinical Trials Call Center
Oceanside, California, 92056
GSK Clinical Trials Call Center
Palm Beach, Florida, 33409
GSK Clinical Trials Call Center
Palm Beach Gardens, Florida, 33410
GSK Clinical Trials Call Center
Pembroke Pines, Florida, 33024
GSK Clinical Trials Call Center
Richardson, Texas, 75080
GSK Clinical Trials Call Center
Ridgewood, New Jersey, 07450
GSK Clinical Trials Call Center
South Daytona, Florida, 32119
GSK Clinical Trials Call Center
St. Petersburg, Florida, 33701
GSK Clinical Trials Call Center
Tacoma, Washington, 98405
GSK Clinical Trials Call Center
Tulsa, Oklahoma, 74104
GSK Clinical Trials Call Center
West Palm Beach, Florida, 33407
GSK Clinical Trials Call Center
Winston-Salem, North Carolina, 27103
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Tolerability of a 14 Day Treatment Course of GW493838 50mg Compared to Placebo in Subjects With Peripheral Neuropathic Pain
The purpose of this study was to determine the analgesic effect of GW493838 in patients with post-herpetic neuralgia or peripheral nerve injury caused by trauma or surgery.
- Conditions
- Neuropathic Pain
- Being tested
- GW493838
- Keywords
- neuropathic pain
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GW493838Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Secondary outcomes (1)
Safety Pain relief Global Impression of Change Pain quality Evoked pain intensity Area of allodynia Onset of effect Responder rate Rescue medication pharmacokinetics
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2006 (estimated)
- Study startNov 2002
- Primary completionJun 2003
- Study completionJun 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 113 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
- NCT00376454
- Sponsor's protocol ID
- A1A20004
- Status last verified
- Feb 2013
- First submitted
- 13 Sep 2006
- Last updated
- 12 Feb 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Tolerability of a 14 Day Treatment Course of GW493838 50mg Compared to Placebo in Subjects With Peripheral Neuropathic Pain
- ClinicalTrials.gov ID
- NCT00376454
- Acronym / sponsor ID
- A1A20004
- Conditions
- Neuropathic Pain
- Keywords
- neuropathic pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Nov 2002
- Primary completion
- Jun 2003 (actual)
- Study completion
- Jun 2003 (actual)
- First posted
- 14 Sep 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 purpose of this study was to determine the analgesic effect of GW493838 in patients with post-herpetic neuralgia or peripheral nerve injury caused by trauma or surgery.
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 (0 listed)
Key exclusion criteria (14 listed)
- discontinue agents for the treatment of neuropathic pain
- unable to refrain from alcohol and sedative use during the study
- confounding chronic pain which could not be differentiated from the peripheral neuropathic pain under study
- intractable pain of unknown origin or active infection in the area of nerve injury.
- clinically significant medical history or abnormality found on physical examination, laboratory assessment or ECG at Screening or Baseline
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 |
|---|---|---|
| GW493838 | Drug | – |
Primary outcome
Pain intensity
1 secondary outcome
Safety Pain relief Global Impression of Change Pain quality Evoked pain intensity Area of allodynia Onset of effect Responder rate Rescue medication pharmacokinetics
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 12 Feb 2013.
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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
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GW493838 in people with Neuropathic Pain, run by GlaxoSmithKline at 32 sites in United States.
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 0 inclusion and 14 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 12 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States. 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?
Pain intensity. 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 12 Feb 2013; AzTrials last refreshed its copy on 7 Nov 2026.