Once Daily Gabapentin in the Treatment of Post Amputation Pain

• Status: Unknown status
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chicago Anesthesia Pain Specialists
• Treatments: Gabapentin

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