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

Low Back Pain Clinical Trial

Official title:

Efficacy and Safety of ARTRA (Glucosamine Plus Chondroitin Sulfate Combination) in Treatment of Non-specific Chronic Low Back Pain of Lumbosacral Localization in Ambulatory Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01990729
• Other study ID #: ARTRA-PMS-LBP/2012
• Status: Completed
• Phase: N/A
• First received: October 7, 2013
• Last updated: November 15, 2013
• Start date: July 2010
• Est. completion date: January 2013

Study information

• Verified date: November 2013
• Source: Unipharm, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10000
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 65 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Dietary Supplement:
• ARTRA
ARTRA (glucosamine and chondroitin sulfate)

Locations

Country	Name	City	State
Russian Federation	FGBU "State NII of Rheumatology" of RAMS	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Unipharm, Inc.

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Intensity	Pain intensity on Visual Analogue Scale	3 months	No
Secondary	Oswestry Disability Index		3 months	No
Secondary	Patient global assessment of efficacy		3 months	No
Secondary	NSAID consumption	Number of patients taking NSAIDs	3 months	No