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
  Purpose

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.


Condition Intervention Phase
Pain
Quality of Life
Drug: Gralise
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Once Daily Gastroretentive Gabapentin (Gralise) in the Treatment of Post Amputation Pain

Resource links provided by NLM:


Further study details as provided by Chicago Anesthesia Pain Specialists:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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.


Estimated Enrollment: 20
Study Start Date: February 2013
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Gralise
Efficacy of Gralise
Drug: Gralise
Titration starting 300 mg/day up to 1800 mg/day over 2 weeks
Other Name: Gralise

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01776671

Contacts
Contact: Nick N Knezevic, M.D. Ph.D. 773-296-7927 aimmc.anesthesia.research@gmail.com

Locations
United States, Illinois
Chicago Anesthesia Pain Specialists Recruiting
Chicago, Illinois, United States, 60639
Contact: Nick N Knezevic, M.D. Ph.D.    773-296-7927    aimmc.anesthesia.research@gmail.com   
Principal Investigator: Kenneth D Candido, MD         
Sponsors and Collaborators
Chicago Anesthesia Pain Specialists
Investigators
Principal Investigator: Kenneth D Candido, M.D. Chicago Anesthesia Pain Specialists
  More Information

No publications provided

Responsible Party: Kenneth D Candido, Chairman of the Anesthesia Department, Chicago Anesthesia Pain Specialists
ClinicalTrials.gov Identifier: NCT01776671     History of Changes
Other Study ID Numbers: Advocate-IRB-5367
Study First Received: January 24, 2013
Last Updated: March 12, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Anticonvulsants
Gabapentin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents

ClinicalTrials.gov processed this record on September 11, 2014