Once Daily Gabapentin in the Treatment of Post Amputation Pain

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Chicago Anesthesia Pain Specialists
Sponsor:
Information provided by (Responsible Party):
Kenneth D Candido, Chicago Anesthesia Pain Specialists
ClinicalTrials.gov Identifier:
NCT01776671
First received: January 24, 2013
Last updated: March 12, 2013
Last verified: March 2013

January 24, 2013
March 12, 2013
February 2013
February 2014   (final data collection date for primary outcome measure)
Change in Pain Numeric Rating Scale at rest [ Time Frame: Visit 1, 2, 3, 4, 5, 6 ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01776671 on ClinicalTrials.gov Archive Site
Change in Pain numeric rating scale at movement. [ Time Frame: Visit 1, 2, 3, 4, 5, 6 ] [ Designated as safety issue: No ]
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.
Same as current
Modified brief pain inventory (short form) [ Time Frame: Visit 1, and visit 5 ] [ Designated as safety issue: No ]
Visit 1, baseline; visit 5, eight weeks after visit 1.
Same as current
 
Once Daily Gabapentin in the Treatment of Post Amputation Pain
Efficacy of Once Daily Gastroretentive Gabapentin (Gralise) in the Treatment of Post Amputation Pain

Phantom limb pain (PLP) is a common disorder reported by the patients who undergo amputation. Even though the cause of PLP remains unclear, Gabapentin has been widely used. The purpose of this study is to evaluate the accuracy and efficacy achieved in using of extended release Gabapentin. Reducing the incidence of chronic post-amputation pain and improving clinical outcomes postoperatively.

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.

Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Pain
  • Quality of Life
Drug: Gralise
Titration starting 300 mg/day up to 1800 mg/day over 2 weeks
Other Name: Gralise
Gralise
Efficacy of Gralise
Intervention: Drug: Gralise
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
April 2014
February 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
Both
18 Years and older
No
Contact: Nick N Knezevic, M.D. Ph.D. 773-296-7927 aimmc.anesthesia.research@gmail.com
United States
 
NCT01776671
Advocate-IRB-5367
No
Kenneth D Candido, Chicago Anesthesia Pain Specialists
Chicago Anesthesia Pain Specialists
Not Provided
Principal Investigator: Kenneth D Candido, M.D. Chicago Anesthesia Pain Specialists
Chicago Anesthesia Pain Specialists
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP