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

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)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000541

Enrollment

Registered

2009-08-10

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: SST-4005, a Topical Naproxen Cream: 500mg/10 ml twice daily for 14 days Control Intervention1: Matching Topical Placebo Cream: 500mg/10 ml twice daily for 14 days

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Changes from baseline to end of trial in 'low back pain intensity' on 0-100 mm Visual Analog Scale(VAS)Timepoint: After 2 weeks	—

Secondary

Measure	Time frame
1. Mean 0-100 mm VAS Scores during the treatment period. 2. Changes from baseline to end of trial in Roland Morris Disability Questionnaire (RMDQ-24) 3. Mean number of nighttime awakenings due to pain and quality of sleep. 4. Patient reported global assessment of treatment. 5. Physician's Global Assessment of subjects LBP. 6. Use of rescue medication. Timepoint: After 2 weeks;Safety outcomes: 1. Treatment emergent adverse events(TEAEs) 2. Incidence of application site reactions.Timepoint: After 2 weeks.	—

Measure

Time frame

1. Mean 0-100 mm VAS Scores during the treatment period. 2. Changes from baseline to end of trial in Roland Morris Disability Questionnaire (RMDQ-24) 3. Mean number of nighttime awakenings due to pain and quality of sleep. 4. Patient reported global assessment of treatment. 5. Physician's Global Assessment of subjects LBP. 6. Use of rescue medication. Timepoint: After 2 weeks;Safety outcomes: 1. Treatment emergent adverse events(TEAEs) 2. Incidence of application site reactions.Timepoint: After 2 weeks.

—

Countries

India

Contacts

Public ContactDr. Anand Eshwariah

Clinigene International Limited

anand.eswaraiah@clinigeneintl.com080 2808 2728

Outcome results