Once Daily Gabapentin in the Treatment of Post Amputation Pain

NCT01776671 | Unknown Phase 3

• 1 other identifier: Advocate-IRB-5367
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Pain numeric rating scale at movement.

  Visit 1, 2, 3, 4, 5, 6

Other Outcomes (1)

• Modified brief pain inventory (short form)

  Visit 1, and visit 5

Study Arms (1)

Gralise

OTHER

Efficacy of Gralise

Drug: Gralise

Interventions

Gralise DRUG

Titration starting 300 mg/day up to 1800 mg/day over 2 weeks

Gralise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Chicago Anesthesia Pain Specialists: lead

Study Sites (1)

Chicago Anesthesia Pain Specialists

Chicago, Illinois, 60639, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Kenneth D Candido, M.D.

  Chicago Anesthesia Pain Specialists

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman of the Anesthesia Department

Study Record Dates

• First Submitted: January 24, 2013
• First Posted: January 28, 2013
• Study Start: February 1, 2013
• Primary Completion: November 1, 2018
• Study Completion: December 1, 2018
• Last Updated: September 14, 2017

Record last verified: 2017-09

Locations

US (1)