NCT00376454|CompletedPhase 2

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

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

GlaxoSmithKline ClinicalTrials.gov

Compare

1 other identifier

A1A20004

Study Type

interventional

Target

113

Locations

1 country

Sites

Timeline

RegisteredSep 2006

StartedNov 2002

CompletionJun 2003

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

113

participants targeted

Target at P50-P75 for phase_2

Timeline

Completed

Started Nov 2002

Shorter than P25 for phase_2

Geographic Reach

1 country

32 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

7 months study duration

Study Start

First participant enrolled

November 1, 2002

Completed

7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2003

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2003

Completed

3.3 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2006

Completed

1 day until next milestone

First Posted

Study publicly available on registry

September 14, 2006

Completed

Last Updated

February 12, 2013

Status Verified

February 1, 2013

Enrollment Period

7 months

First QC Date

September 13, 2006

Last Update Submit

February 11, 2013

Conditions

Neuropathic Pain

Keywords

neuropathic pain

Outcome Measures

Primary Outcomes (1)

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

Interventions

GW493838DRUG

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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.

Contact the study team to confirm eligibility.