Completed
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
What is being tested
pregabalin
+ placebo
Drug
Who is being recruted
Nervous System Diseases+5
+ Neurologic Manifestations
+ Neuromuscular Diseases
Over 18 Years
+10 Eligibility Criteria
How is the trial designed
Treatment Study
Placebo-ControlledPhase 3
Interventional
Study Start: October 2012
Summary
Principal SponsorPfizer's Upjohn has merged with Mylan to form Viatris Inc.
Last updated: January 28, 2021
Sourced from a government-validated database.Claim as a partner
Study start date: October 1, 2012
Actual date on which the first participant was enrolled.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.
Principal SponsorPfizer's Upjohn has merged with Mylan to form Viatris Inc.
Last updated: January 28, 2021
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
542 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Nervous System DiseasesNeurologic ManifestationsNeuromuscular DiseasesPainPeripheral Nervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeuralgia
Criteria
3 inclusion criteria required to participate
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 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 have sufficient post-traumatic neuropathic pain at screening and baseline
7 exclusion criteria prevent from participating
Subjects considered at risk of suicide or self-harm based on investigator judgment and/or details of a risk assessment
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 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 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
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
Active ComparatorGroup II
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 156 locations
Tennesse Valley Pain Consultants
Huntsville, United StatesOpen Tennesse Valley Pain Consultants in Google MapsDedicated Clinical Research
Goodyear, United StatesElite Clinical Studies, LLC
Phoenix, United StatesHOPE Research Institute
Phoenix, United StatesCompleted156 Study Centers