The Study of GW493838, an Adenosine A1 Agonist, in Peripheral Neuropathic Pain
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00376454 |
|
Recruitment Status :
Completed
First Posted : September 14, 2006
Last Update Posted : February 12, 2013
|
Sponsor:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Neuropathic Pain | Drug: GW493838 | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Enrollment : | 113 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double |
| Primary Purpose: | Treatment |
| 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 Start Date : | November 2002 |
| Actual Primary Completion Date : | June 2003 |
| Actual Study Completion Date : | June 2003 |
Primary Outcome Measures :
- Pain intensity
Secondary Outcome Measures :
- Safety Pain relief Global Impression of Change Pain quality Evoked pain intensity Area of allodynia Onset of effect Responder rate Rescue medication pharmacokinetics
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00376454
Locations
| United States, Alabama | |
| GSK Clinical Trials Call Center | |
| Huntsville, Alabama, United States, 35801 | |
| United States, Arizona | |
| GSK Clinical Trials Call Center | |
| Hot Springs, Arizona, United States, 71913 | |
| United States, Arkansas | |
| GSK Clinical Trials Call Center | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| GSK Clinical Trials Call Center | |
| La Jolla, California, United States, 92037 | |
| GSK Clinical Trials Call Center | |
| Oceanside, California, United States, 92056 | |
| United States, Colorado | |
| GSK Clinical Trials Call Center | |
| Boulder, Colorado, United States, 80304 | |
| United States, Florida | |
| GSK Clinical Trials Call Center | |
| Fort Lauderdale, Florida, United States, 33308 | |
| GSK Clinical Trials Call Center | |
| Ft. Myers, Florida, United States, 33916 | |
| GSK Clinical Trials Call Center | |
| Palm Beach Gardens, Florida, United States, 33410 | |
| GSK Clinical Trials Call Center | |
| Palm Beach, Florida, United States, 33409 | |
| GSK Clinical Trials Call Center | |
| Pembroke Pines, Florida, United States, 33024 | |
| GSK Clinical Trials Call Center | |
| S. Daytona, Florida, United States, 32119 | |
| GSK Clinical Trials Call Center | |
| St. Petersburg, Florida, United States, 33701 | |
| GSK Clinical Trials Call Center | |
| West Palm Beach, Florida, United States, 33407 | |
| United States, Indiana | |
| GSK Clinical Trials Call Center | |
| Evansville, Indiana, United States, 47712 | |
| United States, Kentucky | |
| GSK Clinical Trials Call Center | |
| Lexington, Kentucky, United States, 40503 | |
| GSK Clinical Trials Call Center | |
| Louisville, Kentucky, United States, 40202 | |
| GSK Clinical Trials Call Center | |
| Louisville, Kentucky, United States, 40205 | |
| United States, Louisiana | |
| GSK Clinical Trials Call Center | |
| Covington, Louisiana, United States, 70433 | |
| United States, Massachusetts | |
| GSK Clinical Trials Call Center | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Nevada | |
| GSK Clinical Trials Call Center | |
| Henderson, Nevada, United States, 89052 | |
| United States, New Hampshire | |
| GSK Clinical Trials Call Center | |
| Lebanon, New Hampshire, United States, 03766 | |
| United States, New Jersey | |
| GSK Clinical Trials Call Center | |
| Ridgewood, New Jersey, United States, 07450 | |
| United States, New York | |
| GSK Clinical Trials Call Center | |
| Albany, New York, United States, 12205 | |
| United States, North Carolina | |
| GSK Clinical Trials Call Center | |
| Asheville, North Carolina, United States, 28803 | |
| GSK Clinical Trials Call Center | |
| Winston-Salem, North Carolina, United States, 27103 | |
| United States, Oklahoma | |
| GSK Clinical Trials Call Center | |
| Tulsa, Oklahoma, United States, 74104 | |
| United States, Pennsylvania | |
| GSK Clinical Trials Call Center | |
| Altoona, Pennsylvania, United States, 16601 | |
| GSK Clinical Trials Call Center | |
| Duncansville, Pennsylvania, United States, 16635 | |
| United States, Texas | |
| GSK Clinical Trials Call Center | |
| Richardson, Texas, United States, 75080 | |
| United States, Washington | |
| GSK Clinical Trials Call Center | |
| Tacoma, Washington, United States, 98405 | |
| United States, Wisconsin | |
| GSK Clinical Trials Call Center | |
| Madison, Wisconsin, United States, 53792 | |
Sponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00376454 |
| Other Study ID Numbers: |
A1A20004 |
| First Posted: | September 14, 2006 Key Record Dates |
| Last Update Posted: | February 12, 2013 |
| Last Verified: | February 2013 |
Keywords provided by GlaxoSmithKline:
|
neuropathic pain |
Additional relevant MeSH terms:
|
Neuralgia Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases |
Pain Neurologic Manifestations Signs and Symptoms |