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Clonidine Versus Adenosine to Treat Neuropathic Pain
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by Wake Forest University.   Recruitment status was  Active, not recruiting

First Received on July 5, 2006.   Last Updated on May 12, 2009   History of Changes
Sponsor: Wake Forest University
Collaborator: National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by: Wake Forest University
ClinicalTrials.gov Identifier: NCT00349921
  Purpose

The purpose of this study is to determine the effects of clonidine and adenosine on nerve pain.


Condition Intervention Phase
Pain
Drug: clonidine
Drug: adenosine
Other: placebo
Phase II

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Clonidine Versus Adenosine to Treat Neuropathic Pain

Resource links provided by NLM:


Further study details as provided by Wake Forest University:

Primary Outcome Measures:
  • Percent change in pain report [ Time Frame: 2 hours following injection of study medication ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 28
Study Start Date: August 2004
Estimated Study Completion Date: January 2008
Arms Assigned Interventions
Active Comparator: 1
clonidine
Drug: clonidine
Clonidine—a drug commonly used to treat high blood pressure—has been shown to effectively treat neuropathic pain, is FDA-approved for administration via epidural (an injection given in the lower back), and is the third most commonly prescribed drug for chronic intrathecal (an injection into the cerebrospinal fluid) use in people with chronic pain.
Active Comparator: 2
adenosine
Drug: adenosine
Adenosine—a drug commonly administered intravenously (into a vein) to treat certain types of abnormal heart rhythms—has been found to reduce areas of allodynia (pain caused by a stimulus that does not normally cause pain) after intrathecal, but not intravenous administration in people with neuropathic pain.
Placebo Comparator: 3 Other: placebo
inactive substance

Detailed Description:

This study is part of a pain center grant that focuses on how pain, especially chronic neuropathic pain, alters the response to traditional and non-traditional analgesics (pain medications).

Clonidine—a drug commonly used to treat high blood pressure—has been shown to effectively treat neuropathic pain, is FDA-approved for administration via epidural (an injection given in the lower back), and is the third most commonly prescribed drug for chronic intrathecal (an injection into the cerebrospinal fluid) use in people with chronic pain.

Adenosine—a drug commonly administered intravenously (into a vein) to treat certain types of abnormal heart rhythms—has been found to reduce areas of allodynia (pain caused by a stimulus that does not normally cause pain) after intrathecal, but not intravenous administration in people with neuropathic pain.

Intrathecal clonidine relieves pain by actions on a2-adrenoceptors in the spinal cord, whereas adenosine relieves pain by actions on A1 adenosine receptors. Researchers believe that intrathecal adenosine and clonidine may prove to be excellent painkillers for nerve pain. Therefore, the goal of this study is to determine the effects of clonidine and adenosine on nerve pain.

After initial screening, baseline measurements, and training to learn to estimate pain accurately using thermal heat testing, a sample of spinal fluid will be taken from each participant. Participants then will be randomly chosen to receive either clonidine, adenosine, or placebo. After receiving the study medication, participants will be monitored, with their vital signs checked at 30, 60, 120, 180, and 240 minutes.

Duration of the study for participants is 2 weeks, and includes two visits to the research center, each lasting approximately 6 hours.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with complex regional pain syndrome (CRPS), type I involving a lower extremity

Exclusion Criteria:

  • Pregnancy
  • Allergy to clonidine
  • Currently taking clonidine or other direct a2-adrenergic agonists, or taking cholinesterase inhibitors
  • Patients with any serious or unstable medical problems (heart, lung, liver, kidney, or nervous system disease)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00349921

Locations
United States, North Carolina
The Center for Clinical Research, 145 Kimel Park Drive
Winston-Salem, North Carolina, United States, 27103
Wake Forest University School of Medicine, Medical Center Boulevard
Winston-Salem, North Carolina, United States, 27157-1009
Sponsors and Collaborators
Wake Forest University
Investigators
Principal Investigator: James C. Eisenach, M.D. Wake Forest University
Principal Investigator: Richard Rauck, M.D. The Center for Clinical Research
  More Information

No publications provided

Responsible Party: James C. Eisenach, MD, Professor of Anesthesiology, Wake Forest University School of Medicine
ClinicalTrials.gov Identifier: NCT00349921     History of Changes
Other Study ID Numbers: P01NS041386_TRIAL1, BG 04-280
Study First Received: July 5, 2006
Last Updated: May 12, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Wake Forest University:
pain
chronic pain
clonidine
adenosine
complex regional pain syndrome
CRPS
a2-adrenergic agonists
alpha2-adrenergic agonists

Additional relevant MeSH terms:
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Adenosine
Clonidine
Adrenergic Agonists
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Vasodilator Agents
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists

ClinicalTrials.gov processed this record on February 12, 2012