You are here

A 17-Week Trial To Assess Pregabalin For The Treatment Of Nerve Pain Due To Spinal Cord Injury

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Phoenix, Arizona, 85016 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Neuralgia, Spinal Cord Injuries
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Subjects with nerve pain after Spinal cord injury (traumatic, diving, ischemic and
after removal of benign tumors (except meningioma and fibromas)

- Pain has to be chronic(continuous for at least 3 months or intermittent for at least 6
months

- Pain score at least 4 in 4 of 7 days prior to receive treatment.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Pregabalin use in the last 60 days, prior intolerance to pregabalin

- Creatinine clearance

- White blood cell count 103/ mm3.

- Abuse of drugs or alcohol

- Unstable medial conditions

- Clinically significant abnormal electrocardiogram (ECG).

- Presence of severe pain associated with conditions other than spinal cord injury that
could confound the assessment or self-evaluation of pain due to spinal cord injury.

NCT00407745
Pfizer
Completed
A 17-Week Trial To Assess Pregabalin For The Treatment Of Nerve Pain Due To Spinal Cord Injury

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.

Similar Trials

Neuralgia
NCT00292188
All Genders
18+
Years
Multiple Sites
Diabetic Neuropathies, Neuralgia
NCT00141219
All Genders
18+
Years
Multiple Sites
Post-Herpetic Neuralgia
NCT00159666
All Genders
18+
Years
Multiple Sites
Brain Injuries, Growth Hormone Deficiency
NCT00555009
All Genders
18+
Years
Multiple Sites
A 17-Week Trial To Assess Pregabalin For The Treatment Of Nerve Pain Due To Spinal Cord Injury
A 17-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Trial Of Pregabalin For The Treatment Of Chronic Central Neuropathic Pain After Spinal Cord Injury
The purpose of this study is to evaluate if pregabalin relieves nerve pain associated with spinal cord injury compared to placebo (pill that contains no active medicine). This study will also evaluate the safety of pregabalin in this patient population.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Neuralgia
  • Spinal Cord Injuries
  • Drug: placebo
    Placebo
  • Drug: pregabalin
    Pregabalin capsules taken twice daily up to 17 weeks (150-600 mg/day)
    Other Name: Lyrica
  • Placebo Comparator: matched placebo
    Intervention: Drug: placebo
  • Experimental: pregabalin
    flexible dosing over 4 weeks followed by 12 weeks maintenance and one week taper period
    Intervention: Drug: pregabalin
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
220
February 2011
February 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects with nerve pain after Spinal cord injury (traumatic, diving, ischemic and after removal of benign tumors (except meningioma and fibromas)
  • Pain has to be chronic(continuous for at least 3 months or intermittent for at least 6 months
  • Pain score at least 4 in 4 of 7 days prior to receive treatment.

Exclusion Criteria:

  • Pregabalin use in the last 60 days, prior intolerance to pregabalin
  • Creatinine clearance <60 mL/min.
  • White blood cell count <2500/mm3; neutrophil count <1500/mm3; platelet count <100 x 103/ mm3.
  • Abuse of drugs or alcohol
  • Unstable medial conditions
  • Clinically significant abnormal electrocardiogram (ECG).
  • Presence of severe pain associated with conditions other than spinal cord injury that could confound the assessment or self-evaluation of pain due to spinal cord injury.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Chile,   China,   Colombia,   Czech Republic,   Hong Kong,   India,   Japan,   Philippines,   Russian Federation,   United States
 
 
NCT00407745
A0081107
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now