| Low back pain (LBP) is a highly prevalent condition among middle aged population.
1 LBP is
ranked highest in terms of years lived with disability, with one in ten people experiencing it at
any point in time worldwide. LBP is still one of the most common reasons for general
practice or physician visits worldwide, with a pooled prevalence of care-seeking of 58%. In
the United States, LBP is the third most common reason for visiting a doctor. In Australia,
the proportion of people seeking medical care for LBP has surged by 20% over 10 years. International surveys of low back pain reported that 1-month prevalence was 19% to 43% and
point prevalence was 15% to 30%. The estimated worldwide lifetime prevalence of low back
pain varies from 50% to 84%. The occurrence of low back pain in India is also alarming with
nearly 60% of the people in India have suffered from low back pain at some time during their
lifespan. Osteoarthritis (OA), a common cause of low back pain, involves breakdown of cartilage
(tissue covering the joint surfaces at the ends of bones).OA is the most common form of
arthritis, affecting an estimated 27 million adults in the US. The prevalence of OA has
increased over the past two decades, and increases in life expectancy and obesity, both risk
factors for OA, have led to concerns over the public health consequences of OA.The lumbar spine is a common location for osteoarthritis. OA affects the appendicular and
axial skeleton. The joints involved include facet joints of the lumbar and cervical spine. OA
of the lumbar spine may cause pain in the lower extremity related to referred neural pain.
Primary Objective • To evaluate the efficacy of Flexabenz Gel versus Volini Gel in low back pain due to
osteoarthritis of lumbar spine as assessed by overall pain score on visual analogue
score on Day 31 (±1 day)
Secondary Objectives • To evaluate the efficacy of Flexabenz Gel versus Volini Gel in low back pain due to
osteoarthritis of lumbar spine as assessed by overall pain score on visual analogue
score on Day 16 (±2 days) zDF
• To evaluate the efficacy of Flexabenz Gel versus Volini Gel ), as assessed by VAS
scale on Day 16 (±2 days) and Day 31 (±1 day) in: o Pain at rest o Pain at night o Pain on movement
• To evaluate the efficacy of Flexabenz Gel versus Volini Gel as assessed visual
analogue scale on Day 16 (±2 days) and Day 31 (±1 day) in: o Restriction of movement o Stiffness o Numbness o Tenderness o Kinesalgia
Safety Objectives • Safety and tolerability of the investigational product (IP)
Inclusion criteria 1. Adult male or female patients aged between 18 to 65 years of age (both ages inclusive)
2. Diagnosed with Lower back pain due to osteoarthritis of lumbar spine associated with at
least one of the following symptoms, as assessed on visual analogue scale at
randomization:
• Pain at rest
• Pain at night
• Pain on movement
• Restriction of movement
• Stiffness
• Numbness
• Tenderness
• Kinesalgia
3. Having lower back pain due to osteoarthritis of at least moderate intensity at
randomization, assessed as overall pain score more than or equal to 45 mm and less than
or equal to 75 mm on a visual analogue scale of 100 mm
4. X-ray of lumbar spine showing evidence of OA as per Investigator discretion.
5. Ability to replace all ongoing pain medications at randomization
6. Women of childbearing potential must be willing to consistently use an appropriate
method of contraception
7. Willingness to give their written informed consent to participate in the study and willing
to comply with all aspects of the protocol
Exclusion criteria
1. Patients with known hypersensitivity to active ingredients or inactive ingredients of the
study treatment.
2. Female patients who are pregnant or lactating or planning to be pregnant.
3. Patients receiving physical therapy or heat therapy or acupuncture therapy, and patients
with a history of these therapies within one month prior to enrollment.
4. Patients with known history or evidence of active HIV, hepatitis B, and/or hepatitis C
infections.
5. Patients with impaired liver function, defined as SGOT 2.0 times the upper limit of
normal.
6. Patients with impaired kidney function, confirmed by serum creatinine >2.0 mg/dl.
7. Patients with presence of active peptic ulcer or any other disease affecting the absorption
of drug history of gastrointestinal bleeding (hematemesis or malena).
8. Patients with serum potassium levels outside the normal range (serum potassium range:
3.7 to 5.2 mEq/L
9. Patients who have received study treatment within four weeks prior to screening to treat
any clinical condition.
10. History of coronary artery bypass graft within 6 months of screening.
11. Concomitant use of corticosteroids (any formulation) or use within 30 days of
randomization.
12. Concomitant use of aspirin or use within 6 months prior to randomization.
13. History of asthma, hypertension, myocardial infarction, thrombotic events, stroke,
congestive heart failure that, in the opinion of the investigator, would put the patient at
risk through study period, or would affect the study analyses if the disease exacerbates
during the study
14. Use of anticoagulants, ACE-inhibitors, cyclosporine, diuretics, lithium or methotrexate
within the past month prior to screening
15. Low back pain due to following conditions:
• Acute disc herniation
• Spondylolisthesis
• Ankylosing Spondylitis
• Infection and Malignancy
16. Patients with instability problem, nerve root signs, radiculopathy and postural problem as
assessed by investigator during screening
17. Evidence or history of clinically significant medical or surgical abnormality including
clinically significant laboratory parameters that, in the opinion of the investigator, would
put the patient at risk through study period, or would affect the study analyses if the
disease exacerbates during the study.
18. History of drug/substance abuse
19. Poor general condition, which in the opinion of the Investigator makes the patient
ineligible to participate in the study
20. Patients who are currently enrolled in another clinical study or have been enrolled in any
low back pain research study within 30 days prior to screening.
21. Any other condition that, in the opinion of the investigator, does not justify the inclusion
of the patient in the study.
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