Once Daily Gabapentin in the Treatment of Post Amputation Pain
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|ClinicalTrials.gov Identifier: NCT01776671|
Recruitment Status : Unknown
Verified September 2017 by Kenneth D Candido, Chicago Anesthesia Pain Specialists.
Recruitment status was: Active, not recruiting
First Posted : January 28, 2013
Last Update Posted : September 14, 2017
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|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.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Subject must have post amputation pain persisting for more than six months.
- Be considered in reasonably good health, in the opinion of the investigator, other than the post amputation pain at the screening visit (based upon the results of the medical and surgical history, vital signs, pulse oximetry and physical examination.
- Be ≥ 18 years of age at the time of screening.
Female subject are eligible only if all of the following apply:
- Not pregnant ( negative serum pregnancy test at the screening visit);
- Not lactating
- Consented to use barrier contraceptive methods to avoid pregnancy beginning at least 10 days before check -in and continuing throughout the study up to month after the end of the study.
- Voluntarily provide written informed consent.
- Must in the investigator's opinion, to be able to comply with the study procedure.
- Hypersensitivity or allergy to gabapentin
- History of co-existing epilepsy or uncontrolled seizure disorder
- Subject is suffering from dementia or any cognitive dysfunction
- Have an uncontrolled or poorly controlled major psychiatric condition (e.g. schizophrenia, major depression) or who have clinically significant anxiety or depression
- Severe cardiopulmonary or liver disease
- Impaired kidney function testing
- Patient receiving hemodialysis
- Subjects with current uncontrolled depression or other uncontrolled psychiatric disorder
- Subjects currently taking anticonvulsants for any reason of treatment
- History of untreated alcohol abuse
- History of gastrointestinal symptoms such as: diarrhea, dyspepsia or gastro duodenal ulcers
- Subjects with history of gastric reduction surgery
- Any other clinically significant condition, or unstable inter-current illness that would, in the opinion of the investigator, preclude study participation or interfere with the assessment of the pain
- Clinically significant of uncontrolled hypo or hypertension
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|
|Responsible Party:||Kenneth D Candido, Chairman of the Anesthesia Department, Chicago Anesthesia Pain Specialists|
|Other Study ID Numbers:||
|First Posted:||January 28, 2013 Key Record Dates|
|Last Update Posted:||September 14, 2017|
|Last Verified:||September 2017|
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Molecular Mechanisms of Pharmacological Action