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

Not Applicable

• Conditions: Health Condition 1: M199- Osteoarthritis, unspecified site

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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.

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 <br/ ><br>osteoarthritis of lumbar spine as assessed by overall pain score on visual analogue <br/ ><br>score on Day 31 (±1 day)Timepoint: 31 Days

Secondary Outcome Measures

Name	Time	Method
To evaluate the efficacy of Flexabenz Gel versus Volini Gel ), as assessed by VAS <br/ ><br>scale on Day 16 (±2 days) and Day 31 (±1 day) in: <br/ ><br>o Pain at rest <br/ ><br>o Pain at night <br/ ><br>o Pain on movementTimepoint: 16 Days and 31 Days;To evaluate the efficacy of Flexabenz Gel versus Volini Gel as assessed visual <br/ ><br>analogue scale on Day 16 (±2 days) and Day 31 (±1 day) in: <br/ ><br>o Restriction of movement <br/ ><br>o Stiffness <br/ ><br>o Numbness <br/ ><br>o Tenderness <br/ ><br>o KinesalgiaTimepoint: 16 Days & 31 Days;To evaluate the efficacy of Flexabenz Gel versus Volini Gel in low back pain due to <br/ ><br>osteoarthritis of lumbar spine as assessed by overall pain score on visual analogue <br/ ><br>score on Day 16 (±2 days)Timepoint: 16 Days