Efficacy of Pregabalin in Patients With Radicular Pain

NCT00908375 | Completed Phase 4 Results

• 1 other identifier: FRA7057
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate whether pregabalin is effective in reducing the pain in patients who present with radicular pain due to a herniated disc, spinal stenosis or failed back surgery syndrome.

Conditions

Neuropathy; Radicular, Lumbar, Lumbosacral; Failed Back Surgery Syndrome; Spinal Stenosis; Herniated Disc

Keywords

Pregabalin; Radicular pain; Failed back surgery; Of greater than 3 months duration

Outcome Measures

Primary Outcomes (1)

• Pain Scores (NRS) at 3-weeks

  Standard numeric rating pain scale ranging from 0 (no pain) to 10 (worst pain imaginable) after 3 weeks of treatment. .

  3 weeks

Secondary Outcomes (2)

• Patient's Global Impression of Change at 3 Weeks

  3 weeks

• Oswestry Disability Questionnaires

  3 weeks

Study Arms (2)

Pregabalin

ACTIVE COMPARATOR

A 75mg pregabalin capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks.

Drug: Pregabalin

Surgar Pill

PLACEBO COMPARATOR

One Sugar pill capsule will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 Sugar pill capsules twice a day. The total duration of the treatment will be 3 weeks.

Drug: Sugar Pill

Interventions

Pregabalin DRUG

One pregabalin 75mg capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks.

Also known as: Lyrica®, Pfizer NY, NY 10017

Pregabalin

Sugar Pill DRUG

One sugar pill will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 placebo(sugar pills) capsules twice a day. The total duration of the treatment will be 3 weeks.

Also known as: Placebo

Surgar Pill

Eligibility Criteria

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

You may qualify if:

• Patients with pain in dermatomal distribution, in either cervical or lumbar region.
• History of pain for more than 3 months.
• History of herniated disc, spinal stenosis or failed back surgery.
• A series of epidural steroid injections within the past 6 months.
• Presence of motor or sensory neurological signs (hypoesthesia, hyperesthesia, allodynia, dysesthesia) in the affected dermatomes.
• Patients must be cognitively capable of completing the pain questionnaires.

You may not qualify if:

• Patients below 18 or over 65 years of age.
• Patients with mostly axial spinal pain.
• Presence of significant motor deficits, and /or bowel and/or bladder dysfunction.
• Workmen's compensation or disability issues.
• Patients with chronic depression and on depression medications.
• Addiction and/or substance abuse issues.
• Patients using gabapentin or failure to respond to previous gabapentin use.
• Patients with known peripheral neuropathy (e.g. DPN, PHN etc.).
• Known hypersensitivity to pregabalin use (hives, blisters, rash, dypnea and wheezing).
• History of angioedema with pregabalin use.
• Patients with known renal insufficiency, diabetes, congestive heart failure, cardiac conduction abnormalities, and/or thrombocytopenia.
• Patients using ACE-inhibitors and thiazolidinedione antidiabetic agents (Avandia®, Actos®).
• Pregnant patients.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Pain Medicine Center

Chicago, Illinois, 60610, United States

Location

MeSH Terms

Conditions

Failed Back Surgery Syndrome; Spinal Stenosis; Intervertebral Disc Displacement

Interventions

Pregabalin; Sugars

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Carbohydrates

Limitations and Caveats

Early subject withdrawal and lost to follow-up leading to small numbers of subjects analyzed.

Results Point of Contact

• Title: K Malik
• Organization: Northwestern University

kmalikmd@yahoo.com

3129262280

Study Officials

• Khalid M Malik, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology

Study Record Dates

• First Submitted: May 21, 2009
• First Posted: May 25, 2009
• Study Start: May 1, 2009
• Primary Completion: September 1, 2012
• Study Completion: December 1, 2012
• Last Updated: October 13, 2014
• Results First Posted: September 16, 2014

Record last verified: 2014-09

Locations

US (1)