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

Completed

• Conditions: Low Back Pain
• Interventions: Dietary Supplement: ARTRA

• Registration Number: NCT01990729
• Lead Sponsor: Unipharm, Inc.

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2010-07
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Study First Submitted: 2013-10-07
• Status Verified: 2013-11
• Study First Submitted QC: 2013-11-15
• Last Update Submitted: 2013-11-15
• Study First Posted: 2013-11-21
• Last Update Posted: 2013-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ARTRA	ARTRA	Patients with low back pain treated with ARTRA.

Primary Outcome Measures

Name	Time	Method
Pain Intensity	3 months	Pain intensity on Visual Analogue Scale

Secondary Outcome Measures

Name	Time	Method
Oswestry Disability Index	3 months
Patient global assessment of efficacy	3 months
NSAID consumption	3 months	Number of patients taking NSAIDs

Trial Locations

Locations (1)

FGBU "State NII of Rheumatology" of RAMS; 🇷🇺 Moscow, Russian Federation