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.

Study Overview

• Status: Unknown
• Conditions: Quality of Life; Pain
• Intervention / Treatment: Drug: 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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60639
      • Chicago Anesthesia Pain Specialists

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Gralise; Efficacy of Gralise	Drug: Gralise; Titration starting 300 mg/day up to 1800 mg/day over 2 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain Numeric Rating Scale at rest	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.	Visit 1, 2, 3, 4, 5, 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain numeric rating scale at movement.	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.	Visit 1, 2, 3, 4, 5, 6

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified brief pain inventory (short form)	Visit 1, baseline; visit 5, eight weeks after visit 1.	Visit 1, and visit 5

Collaborators and Investigators

• Sponsor: Chicago Anesthesia Pain Specialists
• Investigators: Principal Investigator: Kenneth D Candido, M.D., Chicago Anesthesia Pain Specialists

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Anticipated): November 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: January 24, 2013
• First Submitted That Met QC Criteria: January 24, 2013
• First Posted (Estimate): January 28, 2013

Study Record Updates

• Last Update Posted (Actual): September 14, 2017
• Last Update Submitted That Met QC Criteria: September 13, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Tranquilizing Agents; Psychotropic Drugs; Anti-Anxiety Agents; Anticonvulsants; Antimanic Agents; Gabapentin
• Other Study ID Numbers: Advocate-IRB-5367

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No