Clinical trial NCT00376454: The Study of GW493838, an Adenosine A1 Agonist, in Peripheral Neuropathic Pain
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neuropathic Pain
Keywords: neuropathic pain
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-09-14
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion criteria (subjects must meet all of the following criteria in order to be eligible for this study):

* Females of non-child-bearing potential
* diagnosis of peripheral neuropathic pain as a result of: postherpetic neuralgia (PHN) from shingles for at least 3 months duration OR focal neuropathic pain related to nerve injury caused by trauma or surgery
* defined area of pain

Exclusion criteria

* 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.
* 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.

Primary outcomes:
measure: Pain intensity
Secondary outcomes:
measure: Safety Pain relief Global Impression of Change Pain quality Evoked pain intensity Area of allodynia Onset of effect Responder rate Rescue medication pharmacokinetics
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: GSK Clinical Trials Call Center
state: Alabama
city: Hot Springs
country: United States
facility: GSK Clinical Trials Call Center
state: Arizona
city: Little Rock
country: United States
facility: GSK Clinical Trials Call Center
state: Arkansas
city: La Jolla
country: United States
facility: GSK Clinical Trials Call Center
state: California
city: Oceanside
country: United States
facility: GSK Clinical Trials Call Center
state: California
city: Boulder
country: United States
facility: GSK Clinical Trials Call Center
state: Colorado
city: Fort Lauderdale
country: United States
facility: GSK Clinical Trials Call Center
state: Florida
city: Ft. Myers
country: United States
facility: GSK Clinical Trials Call Center
state: Florida
city: Palm Beach Gardens
country: United States
facility: GSK Clinical Trials Call Center
state: Florida
city: Palm Beach
country: United States
facility: GSK Clinical Trials Call Center
state: Florida
city: Pembroke Pines
country: United States
facility: GSK Clinical Trials Call Center
state: Florida
city: S. Daytona
country: United States
facility: GSK Clinical Trials Call Center
state: Florida
city: St. Petersburg
country: United States
facility: GSK Clinical Trials Call Center
state: Florida
city: West Palm Beach
country: United States
facility: GSK Clinical Trials Call Center
state: Florida
city: Evansville
country: United States
facility: GSK Clinical Trials Call Center
state: Indiana
city: Lexington
country: United States
facility: GSK Clinical Trials Call Center
state: Kentucky
city: Louisville
country: United States
facility: GSK Clinical Trials Call Center
state: Kentucky
city: Louisville
country: United States
facility: GSK Clinical Trials Call Center
state: Kentucky
city: Covington
country: United States
facility: GSK Clinical Trials Call Center
state: Louisiana
city: Boston
country: United States
facility: GSK Clinical Trials Call Center
state: Massachusetts
city: Henderson
country: United States
facility: GSK Clinical Trials Call Center
state: Nevada
city: Lebanon
country: United States
facility: GSK Clinical Trials Call Center
state: New Hampshire
city: Ridgewood
country: United States
facility: GSK Clinical Trials Call Center
state: New Jersey
city: Albany
country: United States
facility: GSK Clinical Trials Call Center
state: New York
city: Asheville
country: United States
facility: GSK Clinical Trials Call Center
state: North Carolina
city: Winston-Salem
country: United States
facility: GSK Clinical Trials Call Center
state: North Carolina
city: Tulsa
country: United States
facility: GSK Clinical Trials Call Center
state: Oklahoma
city: Altoona
country: United States
facility: GSK Clinical Trials Call Center
state: Pennsylvania
city: Duncansville
country: United States
facility: GSK Clinical Trials Call Center
state: Pennsylvania
city: Richardson
country: United States
facility: GSK Clinical Trials Call Center
state: Texas
city: Tacoma
country: United States
facility: GSK Clinical Trials Call Center
state: Washington
city: Madison
country: United States
facility: GSK Clinical Trials Call Center
state: Wisconsin
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials, MD
role: STUDY_DIRECTOR
References: