Trial Outcomes & Findings for Clonidine Versus Adenosine to Treat Neuropathic Pain (NCT NCT00349921)
NCT ID: NCT00349921
Last Updated: 2018-09-10
Results Overview
Verbal pain report 2 hours post injection compared to baseline verbal pain scores prior to injection
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
baseline and 2 hours
Results posted on
2018-09-10
Participant Flow
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.
24 subjects consented and enrolled 2 subjects withdrawn prior to group assignment because they did not meet inclusion / exclusion criteria on second review
Participant milestones
| Measure |
Clonidine First, Then Adenosine
Clonidine given during the first period and adenosine given during the second period
|
Adenosine First, Then Clonidine
Adenosine given during the first period and adenosine given during the second
|
Clonidine First, Then Placebo
Clonidine given as during the first period, then placebo during the second
|
Adenosine First, Then Placebo
Adenosine given during the first period and placebo given during the second
|
|---|---|---|---|---|
|
First Spinal Injection
STARTED
|
10
|
10
|
1
|
1
|
|
First Spinal Injection
COMPLETED
|
9
|
10
|
0
|
1
|
|
First Spinal Injection
NOT COMPLETED
|
1
|
0
|
1
|
0
|
|
Second Spinal Injection
STARTED
|
9
|
10
|
0
|
1
|
|
Second Spinal Injection
COMPLETED
|
9
|
10
|
0
|
1
|
|
Second Spinal Injection
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Clonidine First, Then Adenosine
Clonidine given during the first period and adenosine given during the second period
|
Adenosine First, Then Clonidine
Adenosine given during the first period and adenosine given during the second
|
Clonidine First, Then Placebo
Clonidine given as during the first period, then placebo during the second
|
Adenosine First, Then Placebo
Adenosine given during the first period and placebo given during the second
|
|---|---|---|---|---|
|
First Spinal Injection
Physician Decision
|
1
|
0
|
0
|
0
|
|
First Spinal Injection
Adverse Event
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Clonidine Versus Adenosine to Treat Neuropathic Pain
Baseline characteristics by cohort
| Measure |
Clonidine First, Then Adenosine
n=10 Participants
clonidine given in first injection adenosine given in second injection
|
Adenosine Given First, Then Clonidine
n=10 Participants
adenosine given in first injection clonidine given in second injection
|
Clonidine Given First, Then Placebo
n=1 Participants
clonidine given first placebo given in second injection
|
Adenosine First, Then Placebo
n=1 Participants
adenosine given in first injection placebo given in second injection
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
45.2 years
STANDARD_DEVIATION 6.4 • n=5 Participants
|
43.7 years
STANDARD_DEVIATION 10.8 • n=7 Participants
|
19 years
STANDARD_DEVIATION 0 • n=5 Participants
|
54 years
STANDARD_DEVIATION 0 • n=4 Participants
|
43.7 years
STANDARD_DEVIATION 10.1 • n=21 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
22 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: baseline and 2 hoursPopulation: The primary outcome measure will be % change in pain report 2 hr following injection, using a response criterion of 30% reduction in ongoing pain.
Verbal pain report 2 hours post injection compared to baseline verbal pain scores prior to injection
Outcome measures
| Measure |
Clonidine
n=21 Participants
clonidine received as either first or second injection
|
Adenosine
n=20 Participants
Adenosine received as either first or second injection
|
Placebo
n=1 Participants
Placebo received as either first or second injection
|
|---|---|---|---|
|
Number Meeting Success Criterion
|
10 participants meeting success criterion
|
5 participants meeting success criterion
|
0 participants meeting success criterion
|
Adverse Events
Clonidine First, Then Adenosine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Adenosine First, Then Clonidine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Clonidine First, Then Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Adenosine First, Then Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Regina Curry, RN, CCRC
Wake Forest University Health Sciences
Phone: (336) 716-4294
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place