Study to demonstrate the pain reduction efficacy and tolerability of SST-4005, a topical Naproxen cream in the treatment of chronic low back pain.

Phase 2

Completed

• Registration Number: CTRI/2009/091/000541
• Lead Sponsor: Strategic Sciences and Technologies, LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified