CTRI/2020/11/029282尚未招募未知
A Prospective, Single center, Investigator Initiated, Openlabel, Randomized, Parallel-group, Active-controlledClinical Study to Evaluate the Efficacy and Safety ofFlexabenz Gel versus Volini Gel in the treatment ofPatients with Low Back Pain due to Osteoarthritis ofLumbar Spine
okmanya Medical Research Center0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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
- •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
排除标准
- •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
- •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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