Once Daily Gabapentin in the Treatment of Post Amputation Pain

• ClinicalTrials.gov Identifier: NCT01776671
• Recruitment Status: Unknown
• First Posted: January 28, 2013
• Last Update Posted: September 14, 2017
• Sponsor: Chicago Anesthesia Pain Specialists
• Information provided by (Responsible Party): Kenneth D Candido, Chicago Anesthesia Pain Specialists

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Pain; Quality of Life	Drug: Gralise	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 16 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.

Other Outcome Measures:

1. Modified brief pain inventory (short form) [ Time Frame: Visit 1, and visit 5 ]
   Visit 1, baseline; visit 5, eight weeks after visit 1.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

United States, Illinois

Chicago Anesthesia Pain Specialists

Chicago, Illinois, United States, 60639

Sponsors and Collaborators

Chicago Anesthesia Pain Specialists

Investigators

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

More Information

• Responsible Party: Kenneth D Candido, Chairman of the Anesthesia Department, Chicago Anesthesia Pain Specialists
• ClinicalTrials.gov Identifier: NCT01776671
• Other Study ID Numbers: Advocate-IRB-5367
• First Posted: January 28, 2013
• Last Update Posted: September 14, 2017
• Last Verified: September 2017

Additional relevant MeSH terms:

Gabapentin; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anticonvulsants; Anti-Anxiety Agents; Tranquilizing Agents; Central Nervous System Depressants; Psychotropic Drugs; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antimanic Agents