Status:
COMPLETED
PROs in Chronic Low Back Pain Patients With Accompanying Lower Limb Pain (Neuropathic Component) Treated With Pregabalin
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Low-Back Pain
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to evaluate the effect of pregabalin comparing with the conventional analgesic care in chronic low back pain patients with accompanying lower limb pain (neuropathic compon...
Detailed Description
Rational and background : The care for low back pain associated with neuropathic pain is a problem often encountered in daily outpatient. And the care effectiveness has been frequently evaluated by ...
Eligibility Criteria
Inclusion
- Subject who received the enough study information and signed informed consent form.
- Subject who had chronic low back pain accompanying with lower limb pain from the knee to the ankle.
- Subject is male or female patient ≥18 years old.
- Subject who has complained low back pain for 3 months or more before Visit 1.
- Subject who is refractory to prior analgesics for 3 months and more.
- Subject who is able and willing to complete all study related assessment and comply with the study schedule and clinical procedures at clinic.
- Subject whose pain Numeric Rating Scale(NRS) ≥ 5 at baseline (based on recall over the past week)
Exclusion
- Subject who, in the opinion of the investigator, was not likely to complete the trial for whatever reason.
- Subject who has been already treated by pregabalin
Key Trial Info
Start Date :
July 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
331 Patients enrolled
Trial Details
Trial ID
NCT02273908
Start Date
July 1 2014
End Date
March 1 2015
Last Update
February 3 2021
Active Locations (33)
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1
Kimura Clinic
Nagoya, Aichi-ken, Japan
2
Jin Orthopaedic Clinic
Ichikawa, Chiba, Japan, 272-0133
3
Satoh Orthopaedic Clinic
Ichikawa, Chiba, Japan
4
Shiraishi Orthopaedic Clinic
Ichikawa, Chiba, Japan