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| Study Type: | Interventional |
|---|---|
| Study Design: | Endpoint Classification: Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment |
| Condition: |
Pain |
| Intervention: |
Drug: clonidine |
Participant Flow
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| Subjects were recruited from 9/1/2004-6/2/2006. Subjects were recruited from a pain clinic and the control group were healthy subjects. |
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| No significant events or abnormal approaches noted. |
| Description | |
|---|---|
| Neuropathic Pain Subjects | Participants will be trained to accurately estimate pain by way of thermal heat testing. Next a small amount of spinal fluid will be withdrawn from each participant to measure the amounts of naturally-made chemicals in the participants' cerebrospinal fluid. Participants then will receive an injection of clonidine. After the injection, additional samples of spinal fluid will be taken to measure chemical changes in the fluid. |
| Healthy Subjects | Participants will be trained to accurately estimate pain by way of thermal heat testing. Next a small amount of spinal fluid will be withdrawn from each participant to measure the amounts of naturally-made chemicals in the participants' cerebrospinal fluid. Participants then will receive an injection of clonidine. After the injection, additional samples of spinal fluid will be taken to measure chemical changes in the fluid. |
| Neuropathic Pain Subjects | Healthy Subjects | |
|---|---|---|
| STARTED | 24 | 19 |
| COMPLETED | 24 | 19 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Description | |
|---|---|
| Neuropathic Pain Subjects | Participants will be trained to accurately estimate pain by way of thermal heat testing. Next a small amount of spinal fluid will be withdrawn from each participant to measure the amounts of naturally-made chemicals in the participants' cerebrospinal fluid. Participants then will receive an injection of clonidine. After the injection, additional samples of spinal fluid will be taken to measure chemical changes in the fluid. |
| Healthy Subjects | Participants will be trained to accurately estimate pain by way of thermal heat testing. Next a small amount of spinal fluid will be withdrawn from each participant to measure the amounts of naturally-made chemicals in the participants' cerebrospinal fluid. Participants then will receive an injection of clonidine. After the injection, additional samples of spinal fluid will be taken to measure chemical changes in the fluid. |
| Neuropathic Pain Subjects | Healthy Subjects | Total | |
|---|---|---|---|
|
Number of Participants
[units: participants] |
24 | 19 | 43 |
|
Age
[units: participants] |
|||
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 24 | 19 | 43 |
| >=65 years | 0 | 0 | 0 |
|
Age
[units: years] Mean ± Standard Deviation |
47.875 ± 11.48 | 32 ± 8.51 | 40.86 ± 12.91 |
|
Gender
[units: participants] |
|||
| Female | 18 | 13 | 31 |
| Male | 6 | 6 | 12 |
Outcome Measures
More Information
| 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. |
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
| No text entered. |
| Responsible Party: | James C. Eisenach, MD, Professor of Anesthesiology, Wake Forest University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00350532 History of Changes |
| Other Study ID Numbers: | P01NS041386_TRIAL2 |
| Study First Received: | July 5, 2006 |
| Results First Received: | March 23, 2009 |
| Last Updated: | July 21, 2010 |
| Health Authority: | United States: Food and Drug Administration |