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A Study To Assess The Ability Of A Crossover Study Design To Detect The Efficacy Of Pregabalin In Post-Traumatic Neuropathic Pain Patients

Last updated on October 4, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Calgary, Alberta, T2N 4N1 Canada
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Nerve Pain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-80 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Patients require a diagnosis of post-traumatic peripheral neuropathic pain (NeP),
including post-surgical NeP and NeP due to peripheral nerve injury, which has lasted
at least 3 months following the traumatic event.

- Patients during the screening week must have completed ≥ 4 daily pain scores and have
an average daily pain score ≥ 4.

- Female patients of childbearing potential must have a negative urine pregnancy test at
Screening and be practicing an acceptable form of contraception.

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

- Patients with neuropathic pain (NeP) that is not due to trauma; e.g. patients with
trigeminal neuralgia, central pain, complex region pain syndrome type I, phantom limb
pain, radiculopathy, painful diabetic neuropathy or post-herpetic neuralgia or
patients with any other co-existing pain which cannot be differentiate from NeP of
peripheral origin.

- Patients who have previously failed to respond to pregabalin at a total daily dose of
equal to or greater than 300 mg or are intolerant to those doses.

- Patients who have previously failed to respond to gabapentin at a total daily dose of
equal to or greater than 1800 mg.

- Patients with any type or history of malignancy, except either where there has been no
ongoing treatment for at least 6 months or all basal cell carcinomas; all patients
with a history of brain or spinal tumors will be excluded.

- Patients who currently have ongoing litigation related to any injury affecting their
pain symptomatology.

NCT00654940
Pfizer
Completed
A Study To Assess The Ability Of A Crossover Study Design To Detect The Efficacy Of Pregabalin In Post-Traumatic Neuropathic Pain Patients

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A Study To Assess The Ability Of A Crossover Study Design To Detect The Efficacy Of Pregabalin In Post-Traumatic Neuropathic Pain Patients
Methodology Study To Assess The Ability Of A Randomized, Double-Blind, Placebo-Controlled, Two Period Crossover Study To Detect The Effect Of Pregabalin In Post-Traumatic Neuropathic Pain Patients
The purpose of this study is to assess whether a cross-over type study design in post-traumatic neuropathic patients can be used to assess the activity of potential analgesic agents
Methodology study to evaluate a cross-over study design in post-traumatic neuropathic pain patients.
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Nerve Pain
  • Drug: Pregabalin (Lyrica)
    Oral, 75mg or 150mg capsules, BID
  • Drug: Placebo
    Oral, matched capsules, BID
  • Active Comparator: A
    Intervention: Drug: Pregabalin (Lyrica)
  • Placebo Comparator: B
    Intervention: Drug: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
February 2009
February 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients require a diagnosis of post-traumatic peripheral neuropathic pain (NeP), including post-surgical NeP and NeP due to peripheral nerve injury, which has lasted at least 3 months following the traumatic event.
  • Patients during the screening week must have completed ? 4 daily pain scores and have an average daily pain score ? 4.
  • Female patients of childbearing potential must have a negative urine pregnancy test at Screening and be practicing an acceptable form of contraception.

Exclusion Criteria:

  • Patients with neuropathic pain (NeP) that is not due to trauma; e.g. patients with trigeminal neuralgia, central pain, complex region pain syndrome type I, phantom limb pain, radiculopathy, painful diabetic neuropathy or post-herpetic neuralgia or patients with any other co-existing pain which cannot be differentiate from NeP of peripheral origin.
  • Patients who have previously failed to respond to pregabalin at a total daily dose of equal to or greater than 300 mg or are intolerant to those doses.
  • Patients who have previously failed to respond to gabapentin at a total daily dose of equal to or greater than 1800 mg.
  • Patients with any type or history of malignancy, except either where there has been no ongoing treatment for at least 6 months or all basal cell carcinomas; all patients with a history of brain or spinal tumors will be excluded.
  • Patients who currently have ongoing litigation related to any injury affecting their pain symptomatology.
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Sweden
 
 
NCT00654940
A0081187
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2010

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.

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1-800-718-1021

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Contact

[email protected]



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