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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Pain
Interventions Drug: clonidine
Drug: adenosine
Drug: placebo
Enrollment 24
Recruitment Details 24 Subjects with chronic pain were recruited from the Center for Clinical Research. Each subject was scheduled for a study visit and randomized to receive spinal clonidine, spinal adenosine or placebo. The subject was scheduled for a second study visit and received the opposite treatment from the first visit.
Pre-assignment Details 24 subjects consented and enrolled 2 subjects withdrawn prior to group assignment because they did not meet inclusion / exclusion criteria on second review
Arm/Group Title Clonidine First, Then Adenosine Adenosine First, Then Clonidine Clonidine First, Then Placebo Adenosine First, Then Placebo
Hide Arm/Group Description Clonidine given during the first period and adenosine given during the second period Adenosine given during the first period and adenosine given during the second Clonidine given as during the first period, then placebo during the second Adenosine given during the first period and placebo given during the second
Period Title: First Spinal Injection
Started 10 10 1 1
Completed 9 10 0 1
Not Completed 1 0 1 0
Reason Not Completed
Physician Decision             1             0             0             0
Adverse Event             0             0             1             0
Period Title: Second Spinal Injection
Started 9 [1] 10 0 1
Completed 9 10 0 1
Not Completed 0 0 0 0
[1]
One patient experienced an adverse event after period one and did not participate in period two
Arm/Group Title Clonidine First, Then Adenosine Adenosine Given First, Then Clonidine Clonidine Given First, Then Placebo Adenosine First, Then Placebo Total
Hide Arm/Group Description clonidine given in first injection adenosine given in second injection adenosine given in first injection clonidine given in second injection clonidine given first placebo given in second injection adenosine given in first injection placebo given in second injection Total of all reporting groups
Overall Number of Baseline Participants 10 10 1 1 22
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 1 participants 1 participants 22 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
 100.0%
10
 100.0%
1
 100.0%
1
 100.0%
22
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 1 participants 1 participants 22 participants
45.2  (6.4) 43.7  (10.8) 19  (0) 54  (0) 43.7  (10.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 1 participants 1 participants 22 participants
Female
8
  80.0%
4
  40.0%
1
 100.0%
1
 100.0%
14
  63.6%
Male
2
  20.0%
6
  60.0%
0
   0.0%
0
   0.0%
8
  36.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 10 participants 1 participants 1 participants 22 participants
10 10 1 1 22
1.Primary Outcome
Title Number Meeting Success Criterion
Hide Description Verbal pain report 2 hours post injection compared to baseline verbal pain scores prior to injection
Time Frame baseline and 2 hours
Hide Outcome Measure Data
Hide Analysis Population Description
The primary outcome measure will be % change in pain report 2 hr following injection, using a response criterion of 30% reduction in ongoing pain.
Arm/Group Title Clonidine Adenosine Placebo
Hide Arm/Group Description:
clonidine received as either first or second injection
Adenosine received as either first or second injection
Placebo received as either first or second injection
Overall Number of Participants Analyzed 21 20 1
Measure Type: Number
Unit of Measure: participants meeting success criterion
10 5 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Clonidine, Adenosine
Comments Null hypothesis is that there is no difference between the groups in proportion of patients meeting the success criterion of >30% reduction in visual analog scale pain 120 min after intrathecal injection
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Clonidine First, Then Adenosine Adenosine First, Then Clonidine Clonidine First, Then Placebo Adenosine First, Then Placebo
Hide Arm/Group Description clonidine given in first injection adenosine given in second injection adenosine given in first injection clonidine given in second injection clonidine given first placebo given in second injection adenosine given in first injection placebo given in second injection
All-Cause Mortality
Clonidine First, Then Adenosine Adenosine First, Then Clonidine Clonidine First, Then Placebo Adenosine First, Then Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Clonidine First, Then Adenosine Adenosine First, Then Clonidine Clonidine First, Then Placebo Adenosine First, Then Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/11 (0.00%)   0/1 (0.00%)   0/1 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Clonidine First, Then Adenosine Adenosine First, Then Clonidine Clonidine First, Then Placebo Adenosine First, Then Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/11 (0.00%)   0/1 (0.00%)   0/1 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Regina Curry, RN, CCRC
Organization: Wake Forest University Health Sciences
Phone: (336) 716-4294
EMail: recurry@wfubmc.edu
Layout table for additonal information
Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT00349921     History of Changes
Other Study ID Numbers: P01NS041386_TRIAL1
P01NS041386 ( U.S. NIH Grant/Contract )
First Submitted: July 5, 2006
First Posted: July 10, 2006
Results First Submitted: May 12, 2009
Results First Posted: February 26, 2014
Last Update Posted: September 10, 2018