Once Daily Gabapentin in the Treatment of Post Amputation Pain
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|ClinicalTrials.gov Identifier: NCT01776671|
Recruitment Status : Active, not recruiting
First Posted : January 28, 2013
Last Update Posted : September 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pain Quality of Life||Drug: Gralise||Phase 3|
Phantom limb pain (PLP) is a common disorder reported by the patients who undergo amputation from peripheral vascular disease, peripheral neuropathic disease, neoplasm or traumatic events. Even though the cause of PLP remains unclear and the large number of treatments has been suggested, there is no single treatment regimen proving long lasting pain relief for PLP. However Gabapentin is widely used and have been well suggested recently for the treatment of neuropathic pain.
The purpose of this study is to evaluate the accuracy and efficacy achieved in using of extended release Gabapentin to offer effective pain relief, improvement of sleep function, and decrease problematic side effects related to the peaks and valleys of the drug's short cycle in patients with PLP. Gabapentin has been clearly demonstrated to be effective in neuropathic pain and epilepsy, but as a treatment option for post amputation pain, it has not been tested.
Approximately, 20 patients will be enrolled in the study, after a titration of two weeks a changing in pain intensity and quality of life will be obtained at subsequent visits. We are expected that the accuracy will be of benefit in reducing the incidence of chronic post-amputation pain and improving clinical outcomes postoperatively.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy of Once Daily Gastroretentive Gabapentin (Gralise) in the Treatment of Post Amputation Pain|
|Study Start Date :||February 2013|
|Estimated Primary Completion Date :||November 2018|
|Estimated Study Completion Date :||December 2018|
Efficacy of Gralise
Titration starting 300 mg/day up to 1800 mg/day over 2 weeks
- Change in Pain Numeric Rating Scale at rest [ Time Frame: Visit 1, 2, 3, 4, 5, 6 ]Visit 1, baseline; visit 2, one week after visit one; visit 3, two weeks after visit 1; visit 4, two weeks after visit 3; visit 5, six weeks after visit 3; visit 6, two weeks after visit 5.
- Change in Pain numeric rating scale at movement. [ Time Frame: Visit 1, 2, 3, 4, 5, 6 ]Visit 1, baseline; visit 2, one week after visit one; visit 3, two weeks after visit 1; visit 4, two weeks after visit 3; visit 5, six weeks after visit 3; visit 6, two weeks after visit 5.
- Modified brief pain inventory (short form) [ Time Frame: Visit 1, and visit 5 ]Visit 1, baseline; visit 5, eight weeks after visit 1.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01776671
|United States, Illinois|
|Chicago Anesthesia Pain Specialists|
|Chicago, Illinois, United States, 60639|
|Principal Investigator:||Kenneth D Candido, M.D.||Chicago Anesthesia Pain Specialists|