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Clonidine Versus Adenosine to Treat Neuropathic Pain

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ClinicalTrials.gov Identifier: NCT00349921
Recruitment Status : Completed
First Posted : July 10, 2006
Results First Posted : February 26, 2014
Last Update Posted : September 10, 2018
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Tracking Information
First Submitted Date  ICMJE July 5, 2006
First Posted Date  ICMJE July 10, 2006
Results First Submitted Date  ICMJE May 12, 2009
Results First Posted Date  ICMJE February 26, 2014
Last Update Posted Date September 10, 2018
Study Start Date  ICMJE August 2004
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 8, 2014)
Number Meeting Success Criterion [ Time Frame: baseline and 2 hours ]
Verbal pain report 2 hours post injection compared to baseline verbal pain scores prior to injection
Original Primary Outcome Measures  ICMJE
 (submitted: July 5, 2006)
Percent change in pain report 2 hour following injection of study medication.
Change History Complete list of historical versions of study NCT00349921 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clonidine Versus Adenosine to Treat Neuropathic Pain
Official Title  ICMJE Clonidine Versus Adenosine to Treat Neuropathic Pain
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pain
Intervention  ICMJE
  • 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.
    Other Name: duraclon
  • 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.
  • Drug: placebo
    inactive substance
    Other Name: dummy
Study Arms  ICMJE
  • Active Comparator: clonidine first, then adenosine
    clonidine given in first injection adenosine given in second injection
    Intervention: Drug: clonidine
  • Active Comparator: adenosine first, then clonidine
    adenosine given in first injection clonidine given in second injection
    Intervention: Drug: adenosine
  • Placebo Comparator: clonidine given first, then placebo
    placebo
    Intervention: Drug: placebo
  • Placebo Comparator: adenosine given first, then placebo
    placebo
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 8, 2014)
24
Original Enrollment  ICMJE
 (submitted: July 5, 2006)
28
Actual Study Completion Date  ICMJE January 2008
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00349921
Other Study ID Numbers  ICMJE P01NS041386_TRIAL1
P01NS041386 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wake Forest University Health Sciences
Study Sponsor  ICMJE Wake Forest University Health Sciences
Collaborators  ICMJE National Institute of Neurological Disorders and Stroke (NINDS)
Investigators  ICMJE
Principal Investigator: James C. Eisenach, M.D. Wake Forest University Health Sciences
Principal Investigator: Richard Rauck, M.D. The Center for Clinical Research
PRS Account Wake Forest University Health Sciences
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP