You are here

Placebo-controlled Safety and Efficacy Study of Pregabalin in Subjects With Post-traumatic Peripheral Neuropathic Pain

Last updated on May 9, 2018

FOR MORE INFORMATION
Study Location
Tennesse Valley Pain Consultants
Huntsville, Alabama, 35801 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Neuropathic Pain
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 must have chronic peripheral neuropathic pain present for than 6 months after
a traumatic or surgical event such as, for example, motor vehicle accident, fall,
sports injury, knee or hip replacement, hernia repair, thoracotomy, mastectomy,
focal/localized burns or crush injury.

- Subjects must be literate and have the ability (unaided) to understand and use the
interactive voice response system (IVRS), have daily access to a telephone in order to
complete the IVRS assessments each day, perform telephone visits and complete all
required assessments/forms.

- Subjects must have sufficient post-traumatic neuropathic pain at screening and
baseline.

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

- Subjects with neuropathic pain due to diabetic peripheral neuropathy (DPN), post
herpetic neuralgia (PHN), HIV, trigeminal neuralgia (TGN), carpal tunnel syndrome
(CTS) or with central neuropathic pain (for example, due to spinal cord injury) or
with Complex Regional Pain Syndrome (CRPS, Type I or Type II).

- Subjects with other pain that may confound assessment or self-evaluation of the
peripheral neuropathic pain.

- Subjects who have failed pregabalin treatment due to lack of efficacy with an adequate
course of therapy at doses greater than or equal to 150 mg/day, who have previously
participated in a pregabalin clinical trial or who have been treated with pregabalin
at any time during the 6 month period prior to screening.

- Subjects with epilepsy; pernicious anemia; hematological illnesses; known HIV
infection; any clinically unstable cardiovascular (including a myocardial infarction
[heart attack] in the 3 months prior to screening), hematological, autoimmune,
endocrine, renal, hepatic (including chronic hepatitis B, hepatitis B within the 3
months prior to screening) respiratory, or gastrointestinal disease; symptomatic
peripheral vascular disease including intermittent claudication; uncontrolled diabetes
mellitus; untreated hypothyroidism.

- Subjects with a diagnosis of DSM-IV TR Axis I disorder (including, for example,
schizophrenia, bipolar disorder) with the exceptions of Generalized Anxiety Disorder
(GAD) or major depression that is clinically stable.

- Subjects considered at risk of suicide or self-harm based on investigator judgment
and/or details of a risk assessment.

- Use of prohibited medications in the absence of appropriate washout periods.

NCT01701362
Pfizer
Completed
Placebo-controlled Safety and Efficacy Study of Pregabalin in Subjects With Post-traumatic Peripheral Neuropathic Pain

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

Sickle Cell Anemia, Sickle Cell Disease, Sickle Cell Disorders, Pain Crisis, Vaso-occlusive Crisis
NCT02433158
All Genders
6+
Years
Multiple Sites
Pain
NCT01266161
All Genders
16+
Years
Multiple Sites
Low Back Pain
NCT02528253
All Genders
18+
Years
Multiple Sites
Placebo-controlled Safety and Efficacy Study of Pregabalin in Subjects With Post-traumatic Peripheral Neuropathic Pain
A Randomized Double Blind Placebo Controlled Parallel Group Study Of The Efficacy And Safety Of Pregabalin (Bid) In Subjects With Post-traumatic Peripheral Neuropathic Pain
This study is designed to investigate if pregabalin is effective in treating neuropathic (nerve) pain resulting from peripheral nerve trauma due to a traumatic or surgical event such as, for example, motor vehicle accident, fall, sports injury, knee or hip replacement, hernia repair, thoracotomy, mastectomy, focal/localized burns or crush injury.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Neuropathic Pain
  • Drug: pregabalin
    capsules, 150-600 mg/day administered in divided doses twice a day for 15 weeks after randomization
    Other Name: Lyrica, PD-144723
  • Drug: placebo
    capsules, placebo for pregabalin administered in divided doses twice a day for 15 weeks after randomization
  • Active Comparator: pregabalin
    Intervention: Drug: pregabalin
  • Placebo Comparator: placebo
    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
542
August 2015
August 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects must have chronic peripheral neuropathic pain present for than 6 months after a traumatic or surgical event such as, for example, motor vehicle accident, fall, sports injury, knee or hip replacement, hernia repair, thoracotomy, mastectomy, focal/localized burns or crush injury.
  • Subjects must be literate and have the ability (unaided) to understand and use the interactive voice response system (IVRS), have daily access to a telephone in order to complete the IVRS assessments each day, perform telephone visits and complete all required assessments/forms.
  • Subjects must have sufficient post-traumatic neuropathic pain at screening and baseline.

Exclusion Criteria:

  • Subjects with neuropathic pain due to diabetic peripheral neuropathy (DPN), post herpetic neuralgia (PHN), HIV, trigeminal neuralgia (TGN), carpal tunnel syndrome (CTS) or with central neuropathic pain (for example, due to spinal cord injury) or with Complex Regional Pain Syndrome (CRPS, Type I or Type II).
  • Subjects with other pain that may confound assessment or self-evaluation of the peripheral neuropathic pain.
  • Subjects who have failed pregabalin treatment due to lack of efficacy with an adequate course of therapy at doses greater than or equal to 150 mg/day, who have previously participated in a pregabalin clinical trial or who have been treated with pregabalin at any time during the 6 month period prior to screening.
  • Subjects with epilepsy; pernicious anemia; hematological illnesses; known HIV infection; any clinically unstable cardiovascular (including a myocardial infarction [heart attack] in the 3 months prior to screening), hematological, autoimmune, endocrine, renal, hepatic (including chronic hepatitis B, hepatitis B within the 3 months prior to screening) respiratory, or gastrointestinal disease; symptomatic peripheral vascular disease including intermittent claudication; uncontrolled diabetes mellitus; untreated hypothyroidism.
  • Subjects with a diagnosis of DSM-IV TR Axis I disorder (including, for example, schizophrenia, bipolar disorder) with the exceptions of Generalized Anxiety Disorder (GAD) or major depression that is clinically stable.
  • Subjects considered at risk of suicide or self-harm based on investigator judgment and/or details of a risk assessment.
  • Use of prohibited medications in the absence of appropriate washout periods.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Bulgaria,   Canada,   Croatia,   Denmark,   Germany,   Hungary,   Korea, Republic of,   Poland,   Puerto Rico,   Romania,   South Africa,   Sweden,   United States
Israel
 
NCT01701362
A0081279
2012-003304-12 ( EudraCT Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2017

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