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Clonidine Versus Adenosine to Treat Neuropathic Pain

Primary Purpose

Pain

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
clonidine
adenosine
placebo
placebo
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring pain, chronic pain, clonidine, adenosine, complex regional pain syndrome, CRPS, a2-adrenergic agonists, alpha2-adrenergic agonists

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • The Center for Clinical Research, 145 Kimel Park Drive
  • Wake Forest University School of Medicine, Medical Center Boulevard

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Placebo Comparator

Arm Label

clonidine first, then adenosine

adenosine first, then clonidine

clonidine given first, then placebo

adenosine given first, then placebo

Arm Description

clonidine given in first injection adenosine given in second injection

adenosine given in first injection clonidine given in second injection

placebo

placebo

Outcomes

Primary Outcome Measures

Number Meeting Success Criterion
Verbal pain report 2 hours post injection compared to baseline verbal pain scores prior to injection

Secondary Outcome Measures

Full Information

First Posted
July 5, 2006
Last Updated
August 10, 2018
Sponsor
Wake Forest University Health Sciences
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT00349921
Brief Title
Clonidine Versus Adenosine to Treat Neuropathic Pain
Official Title
Clonidine Versus Adenosine to Treat Neuropathic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
pain, chronic pain, clonidine, adenosine, complex regional pain syndrome, CRPS, a2-adrenergic agonists, alpha2-adrenergic agonists

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
clonidine first, then adenosine
Arm Type
Active Comparator
Arm Description
clonidine given in first injection adenosine given in second injection
Arm Title
adenosine first, then clonidine
Arm Type
Active Comparator
Arm Description
adenosine given in first injection clonidine given in second injection
Arm Title
clonidine given first, then placebo
Arm Type
Placebo Comparator
Arm Description
placebo
Arm Title
adenosine given first, then placebo
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
clonidine
Other Intervention Name(s)
duraclon
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
adenosine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
dummy
Intervention Description
inactive substance
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
dummy
Intervention Description
inactive substance
Primary Outcome Measure Information:
Title
Number Meeting Success Criterion
Description
Verbal pain report 2 hours post injection compared to baseline verbal pain scores prior to injection
Time Frame
baseline and 2 hours

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James C. Eisenach, M.D.
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Richard Rauck, M.D.
Organizational Affiliation
The Center for Clinical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Center for Clinical Research, 145 Kimel Park Drive
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Wake Forest University School of Medicine, Medical Center Boulevard
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1009
Country
United States

12. IPD Sharing Statement

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Clonidine Versus Adenosine to Treat Neuropathic Pain

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