A prospective, randomized, double- blind, Placebo controlled, parallel group study to demonstrate the Analgesic efficacy and tolerability of SST-4005, a Topical Naproxen Cream in treatment of Chronic Low back pain)

Strategic Sciences and Technologies, LLC0 个研究点目标入组 60 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1. Age 18-60 years of either gender
•2. Low back pain (inferior to T-12 and superior to gluteal fold) lasting more than 12 weeks due to spondylosis, degenerative spinal disease or pain of nonspecific origin.
•3. Post washout period baseline pain intensity score>40 on a 0-100mm numerical ratring scale(VAS)
•4. Willingness to provide informed consent to participate in the study.

•1. Patients with chronic low back pain as a result of recent (<6 months prior to study )major trauma or neuropathic pain.
•2. Patients who had surgical interventions for low back pain< 4 weeks prior to study entry,.
•3. Patients who had received corticosteroids or opiods<90 days prior to enrollment.
•4. Patients with a history of rheumatoid or psoriatic arthritis, spondyloarthropathy, metastatic cancer, paget's disease, sciatica or spinal stenosis and fibromyalgia.
•5. Tumors or infections of the spinal cord, a severe herniated disc, or other diseases known to cause pain.
•6. GAstrointestinal ulcer, gastrointestinal bleeding, hemorrhagic diathesis, either current or previous diagnosis.
•7. Have a history or presence of a significant iuncontrolled systemic disease.
•8. Pregnancy, lactation or planned pregnancy during the study duration.
•9. Mental illness or psychiatric condition which might interfere with the use of subjective questionaire and Visual Analog Scale.
•10. Previously exhibited hypersensitivity to Naproxen, other NSAIDs or any of the inactive ingredients in the product.

发起方

Strategic Sciences and Technologies, LLC