Efficacy Study in Lumbosacral Radiculopathy

2014-08-27 03:14:12 | BioPortfolio


This study will be a double-blind, placebo-controlled, parallel group study. After enrolment and initial assessments, subjects will receive 35 days of study medication. During this treatment period, they will be randomised to either oral GW856553 7.5mg BID or matching placebo in a 1:1 ratio. Sufficient numbers of subjects will be recruited to obtain 128 evaluable subjects.


This is a double-blind, randomised, placebo-controlled, parallel group study. Subjects will undertake a screening period which may last up to approximately 3 weeks, followed by a baseline period of 1 week, a randomised treatment period of 5 weeks and a follow-up period of approximately 2 weeks.

This is a multi-centre, double-blind, randomised, placebo-controlled study in subjects who have at least moderate intensity of neuropathic pain resulting from lumbosacral radiculipathy. It will investigate the efficacy, safety and tolerability of GW856553.

Approximately 142 subjects will be randomised to ensure 128 evaluable subjects. Randomisation ratio will be 1:1 for placebo or GW856553 respectively. The dose of GW856553 will be 7.5 mg BID.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Lumbosacral Radiculopathy


Placebo, GS856553


GSK Investigational Site





Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:14:12-0400

Clinical Trials [81 Associated Clinical Trials listed on BioPortfolio]

Epidural Clonidine for Lumbosacral Radiculopathy

Randomized, blinded study of transforaminal epidural injection of clonidine versus a similar injection of corticosteroid for acute lumbosacral radiculopathy. Hypothesis is that clonidine w...

Study to Evaluate the Efficacy and Safety of BIIB074 in Neuropathic Pain From Lumbosacral Radiculopathy

The primary objective of the study is to evaluate the efficacy of two dose regimens of BIIB074 on neuropathic pain in participants with pain from lumbosacral radiculopathy (PLSR). Secondar...

Effect of Neural Mobilization on Lumbosacral Radiculopathy Patients With Peripheral Sensitization

The primary purpose of this study was to investigate the effects of slider and tensioner techniques on pain, hip and knee ROM in lumbosacral radiculopathy patients with peripheral sensitiz...

Treatment of Pain Associated With Lumbosacral Radiculopathy in Adults

This study will evaluate the safety and effectiveness of a new pain medication in development, clonidine micropellet. Participants will receive a single injection of either clonidine micro...

Lumbar Back Bracing Study

The main objectives of this study are to evaluate the benefits of back bracing in the symptomatic management of patients with CLBP due to degenerative lumbar disc disease. The plan is to s...

PubMed Articles [955 Associated PubMed Articles listed on BioPortfolio]

Work-relatedness of lumbosacral radiculopathy syndrome: Review and dose-response meta-analysis.

Clinicians need to know whether lumbosacral radiculopathy syndrome (LRS) can be attributed to work. This review describes what work-related risk factors are associated with LRS.

Sciatica caused by venous varix compression of the sciatic nerve.

The authors report the case of a 76 year-old woman presenting with leg pain, numbness and weakness mimicking a lumbosacral radiculopathy. Lumbar spine magnetic resonance imaging (MRI) demonstrated mil...

Measurement of cervical multifidus and longus colli muscles dimensions in patients with cervical radiculopathy and healthy controls using ultrasonography: A reliability study.

Cervical radiculopathy is an increasing musculoskeletal disorder, with high prevalence in the office workers. In recent years, ultrasonography (US) is reported to be a valid, non-expensive and non-inv...

Sciatic Neuralgia Caused by May-Thurner Syndrome: Case Report.

Sciatic neuralgia (SN) is a type of pain commonly associated with lumbosacral radiculopathy. May-Thurner syndrome (MTS) is a disease characterized by venous congestion in the left common iliac vein (L...

Treatment of Cervical Myelopathy: Long-term Outcomes of Arthroplasty for Myelopathy Versus Radiculopathy, And Arthroplasty Versus Arthrodesis for Myelopathy.

Analysis of 2- and 7-year outcomes from a clinical trial comparing 2-level cervical disk arthroplasty (CDA) to anterior cervical discectomy and fusion (ACDF) in 287 patients with radiculopathy alone, ...

Medical and Biotech [MESH] Definitions

The lumbar and sacral plexuses taken together. The fibers of the lumbosacral plexus originate in the lumbar and upper sacral spinal cord (L1 to S3) and innervate the lower extremities.

Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.

An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.

A condition characterized by pain radiating from the back into the buttock and posterior/lateral aspects of the leg. Sciatica may be a manifestation of SCIATIC NEUROPATHY; RADICULOPATHY (involving the SPINAL NERVE ROOTS; L4, L5, S1, or S2, often associated with INTERVERTEBRAL DISK DISPLACEMENT); or lesions of the CAUDA EQUINA.

Region of the back including the LUMBAR VERTEBRAE, SACRUM, and nearby structures.

More From BioPortfolio on "Efficacy Study in Lumbosacral Radiculopathy"

Quick Search


Relevant Topics

Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...

An anesthesiologist (US English) or anaesthetist (British English) is a physician trained in anesthesia and perioperative medicine. Anesthesiologists are physicians who provide medical care to patients in a wide variety of (usually acute) situations. ...

The Top 100 Pharmaceutical Companies
Top 10 biotech and pharmaceutical companies worldwide based on market value in 2015 2015 ranking of the global top 10 biotech and pharmaceutical companies based on revenue (in billion U.S. dollars) Johnson & Johnson, U.S. 74...

Searches Linking to this Trial