Efficacy and Safety of ARTRA (Glucosamine Plus Chondroitin Sulfate Combination) in Treatment of Chronic Low Back Pain

Unipharm, Inc.

Status: Completed

Conditions: Low Back Pain

Treatments: Dietary Supplement: ARTRA

Study type: Observational

Funder types: Industry

Identifiers

NCT01990729

ARTRA-PMS-LBP/2012

Details and patient eligibility

About

To study the safety and efficacy of ARTRA (glucosamine chondroitin sulfate) in the treatment of non-specific low-back pain of lumbosacral localization in ambulatory care.

Full description

We enrolled patients between 40 and 65 years of age who had low back pain for at least 12 weeks with a pain intensity >3 on a 0-10 point visual analogue scale (VAS). Major exclusion criteria were presence of fibromyalgia, degenerative spondylolisthesis, and alcohol and/or drug abuse. All patients were treated with ARTRA (combination of glucosamine hydrochloride 500 mg and chondroitin sulfate 500 mg in tab; Unipharm Inc.) at a dose of 1 tab bid for the first month and then 1 tab daily for the next two months. The primary endpoint was pain intensity (at rest and movement) as measured on a 0-10 point VAS. Secondary endpoints included Oswestry Disability Index, patient global assessment of efficacy (0-5 scale) and NSAID consumption.

Enrollment: 10,000 patients

Sex: All

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients aged 40-65 years, inclusively.
2. Pain intensity according to Visual Analogue Scale (VAS) > 3 points.
3. Duration of back pain > 12 weeks.
4. Pain reinforcement during movement in lumbar spine.
5. Osteoarthritis, spondylarthrosis, osteochondrosis.
6. Given written Informed consent form for participation in the study.
7. Treatment with ARTRA

Exclusion criteria

1. History of allergic reactions to chondroprotectors.

2. Participation in another clinical study within 30 days before screening or during this study.

3. Fibromyalgia.

4. Active neoplastic disease, history of neoplastic disease within 3 years before screening.

5. Paget's disease.

6. Degenerative spondylolisthesis.

7. Administration of anticonvulsant, antidepressant, barbiturate, anxiolytic, or muscle relaxant drugs for more than one week prior screening.

8. History of alcohol or drug abuse.

9. Frequent episodes of nausea, dyspepsia, pain in the epigastric region, diarrhea, face and extremities edema, dizziness and headache.

10. History of any disease that, in the opinion of the investigator, might confound the results of the study or poses an additional risk to the subject during participation in the study

11. Clinically significant renal disorders.

Trial design

10,000 participants in 1 patient group

ARTRA

Description:

Patients with low back pain treated with ARTRA.

Treatment:

Dietary Supplement: ARTRA