Study to compare the efficacy and safety of flexabenz gel versus volini gel in patients with low back pain due to osteoarthritis

Not yet recruiting

• Conditions: Osteoarthritis, unspecified site,

• Registration Number: CTRI/2020/11/029282
• Lead Sponsor: Lokmanya Medical Research Center

Brief Summary

Low back pain (LBP) is a highly prevalent condition among middle aged population.1 LBP isranked highest in terms of years lived with disability, with one in ten people experiencing it atany point in time worldwide. LBP is still one of the most common reasons for generalpractice or physician visits worldwide, with a pooled prevalence of care-seeking of 58%. Inthe 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% andpoint prevalence was 15% to 30%. The estimated worldwide lifetime prevalence of low backpain varies from 50% to 84%. The occurrence of low back pain in India is also alarming withnearly 60% of the people in India have suffered from low back pain at some time during theirlifespan. 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 ofarthritis, affecting an estimated 27 million adults in the US. The prevalence of OA hasincreased over the past two decades, and increases in life expectancy and obesity, both riskfactors 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 andaxial skeleton. The joints involved include facet joints of the lumbar and cervical spine. OAof 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 toosteoarthritis of lumbar spine as assessed by overall pain score on visual analoguescore on Day 31 (±1 day)



Secondary Objectives

• To evaluate the efficacy of Flexabenz Gel versus Volini Gel in low back pain due toosteoarthritis of lumbar spine as assessed by overall pain score on visual analoguescore on Day 16 (±2 days)

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• To evaluate the efficacy of Flexabenz Gel versus Volini Gel ), as assessed by VASscale 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 visualanalogue 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 atleast one of the following symptoms, as assessed on visual analogue scale atrandomization:• 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 atrandomization, assessed as overall pain score more than or equal to 45 mm and less thanor 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 appropriatemethod of contraception



7. Willingness to give their written informed consent to participate in the study and willingto comply with all aspects of the protocol



Exclusion criteria



1. Patients with known hypersensitivity to active ingredients or inactive ingredients of thestudy 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 patientswith 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 Cinfections.



5. Patients with impaired liver function, defined as SGOT 2.0 times the upper limit ofnormal.



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 absorptionof 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 treatany 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 ofrandomization.



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 atrisk through study period, or would affect the study analyses if the disease exacerbatesduring the study



14. Use of anticoagulants, ACE-inhibitors, cyclosporine, diuretics, lithium or methotrexatewithin 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 asassessed by investigator during screening



17. Evidence or history of clinically significant medical or surgical abnormality includingclinically significant laboratory parameters that, in the opinion of the investigator, wouldput the patient at risk through study period, or would affect the study analyses if thedisease exacerbates during the study.



18. History of drug/substance abuse



19. Poor general condition, which in the opinion of the Investigator makes the patientineligible to participate in the study



20. Patients who are currently enrolled in another clinical study or have been enrolled in anylow 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 inclusionof the patient in the study.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2020-11-19
• Study Start: 2020-11-20

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

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.
• 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

• Patients with known hypersensitivity to active ingredients or inactive ingredients of the study treatment.
• Female patients who are pregnant or lactating or planning to be pregnant.
• Patients receiving physical therapy or heat therapy or acupuncture therapy, and patients with a history of these therapies within one month prior to enrollment.
• Patients with known history or evidence of active HIV, hepatitis B, and/or hepatitis C infections.
• Patients with impaired liver function, defined as SGOT 2.0 times the upper limit of normal.
• Patients with impaired kidney function, confirmed by serum creatinine >2.0 mg/dl.
• 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.
• History of coronary artery bypass graft within 6 months of screening.
• Concomitant use of corticosteroids (any formulation) or use within 30 days of randomization.
• 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.
• 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.
• Any other condition that, in the opinion of the investigator, does not justify the inclusion of the patient in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the efficacy of Flexabenz Gel versus Volini Gel in low back pain due to	31 Days
osteoarthritis of lumbar spine as assessed by overall pain score on visual analogue	31 Days
score on Day 31 (±1 day)	31 Days

Secondary Outcome Measures

Name	Time	Method
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
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:
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:

Trial Locations

Locations (1)

Lokmanya Medical Research Center; 🇮🇳 Pune, MAHARASHTRA, India

Lokmanya Medical Research Center

🇮🇳Pune, MAHARASHTRA, India

Dr Amit Kale

Principal investigator

9423585027

dramitkale@rediffmail.com