The Study of GW493838, an Adenosine A1 Agonist, in Peripheral Neuropathic Pain

Neuropathic Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00376454
• Other study ID #: A1A20004
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2006
• Last updated: February 11, 2013
• Start date: November 2002
• Est. completion date: June 2003

Study information

• Verified date: February 2013
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: June 2003
• Est. primary completion date: June 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain

Intervention

Drug:
• GW493838

Locations

Country	Name	City	State
United States	GSK Clinical Trials Call Center	Albany	New York
United States	GSK Clinical Trials Call Center	Altoona	Pennsylvania
United States	GSK Clinical Trials Call Center	Asheville	North Carolina
United States	GSK Clinical Trials Call Center	Boston	Massachusetts
United States	GSK Clinical Trials Call Center	Boulder	Colorado
United States	GSK Clinical Trials Call Center	Covington	Louisiana
United States	GSK Clinical Trials Call Center	Duncansville	Pennsylvania
United States	GSK Clinical Trials Call Center	Evansville	Indiana
United States	GSK Clinical Trials Call Center	Fort Lauderdale	Florida
United States	GSK Clinical Trials Call Center	Ft. Myers	Florida
United States	GSK Clinical Trials Call Center	Henderson	Nevada
United States	GSK Clinical Trials Call Center	Hot Springs	Arizona
United States	GSK Clinical Trials Call Center	Huntsville	Alabama
United States	GSK Clinical Trials Call Center	La Jolla	California
United States	GSK Clinical Trials Call Center	Lebanon	New Hampshire
United States	GSK Clinical Trials Call Center	Lexington	Kentucky
United States	GSK Clinical Trials Call Center	Little Rock	Arkansas
United States	GSK Clinical Trials Call Center	Louisville	Kentucky
United States	GSK Clinical Trials Call Center	Louisville	Kentucky
United States	GSK Clinical Trials Call Center	Madison	Wisconsin
United States	GSK Clinical Trials Call Center	Oceanside	California
United States	GSK Clinical Trials Call Center	Palm Beach	Florida
United States	GSK Clinical Trials Call Center	Palm Beach Gardens	Florida
United States	GSK Clinical Trials Call Center	Pembroke Pines	Florida
United States	GSK Clinical Trials Call Center	Richardson	Texas
United States	GSK Clinical Trials Call Center	Ridgewood	New Jersey
United States	GSK Clinical Trials Call Center	S. Daytona	Florida
United States	GSK Clinical Trials Call Center	St. Petersburg	Florida
United States	GSK Clinical Trials Call Center	Tacoma	Washington
United States	GSK Clinical Trials Call Center	Tulsa	Oklahoma
United States	GSK Clinical Trials Call Center	West Palm Beach	Florida
United States	GSK Clinical Trials Call Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity
Secondary	Safety Pain relief Global Impression of Change Pain quality Evoked pain intensity Area of allodynia Onset of effect Responder rate Rescue medication pharmacokinetics