CTRI/2015/10/006269已完成未知
AN INVESTIGATOR INITIATED, PROSPECTIVE, MULTI - CENTER, OPEN LABEL, SINGLE ARMSTUDY TO DETERMINE THE SAFETY AND EFFICACY OF IBUGESIC NANOGEL [TOPICALDICLOFENAC SODIUM GEL WITH NANOTECHNOLOGY] IN SUBJECTSWITH OSTEOARTHRITIS OF KNEE
Mrs Nagalakshmi AnandaPadmanabhan0 个研究点目标入组 50 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •Male or non-pregnant female aged 35 years with a clinical diagnosis
- •of OA of the knee according to the American College of Rheumatology
- •(ACR) criteria:
- •a. Pain in the knee and presence of at least 3 of the following ACR
- •criteria: age 50 years; stiffness lasting for < 30 min; bony
- •tenderness; crepitus; bony enlargement; no palpable warmth, and
- •i. Symptoms for at least 6 months prior to screening, and
- •ii. Knee (not referred) pain for 15 days of the preceding month
- •(periarticular knee pain due to OA and not due to other
- •conditions such as bursitis, tendonitis, etc.), and
- •iii. The pain in the target knee required the use of non-steroidal
- •anti-inflammatory drugs (NSAIDs) or acetaminophen /
- •paracetamol (topical or oral treatments)
- •2. Had an X-ray of the target knee, taken no more than 1 year before
- •baseline, showing evidence of OA with Kellgren-Lawrence grade 1-3 disease
- •3. After discontinuing all pain medications for at least 7 days, had at least
- •moderate POM for target knee, defined as a baseline score of 50 mm
- •on a 0-100 mm VAS and a baseline pain subscale of at least 9.
- •4. Able to tolerate rescue medication (i.e., acetaminophen / paracetamol)
- •5. Subjects willing to refrain from using any other OA treatment during the
- •4-week treatment period, other than the study treatment, and rescue
- •6. Subjects willing to give written informed consent
- •7. Willing and able to comply with the study requirements
- •8. Not pregnant / not planning to be pregnant / not a lactating female.
- •Women of childbearing potential and male subjects were included in the
- •study if they are willing to use an appropriate method of contraception
排除标准
- •X-ray showing evidence of OA with Kellgren-Lawrence grade 4
- •2. History of OA pain in the contralateral knee requiring medication within
- •1 year prior to screening
- •3. After discontinuing all pain medications for at least 7 days, had a
- •baseline score of 20 mm on a 0-100 mm VAS for the contralateral
- •knee immediately prior to randomization
- •4. History of secondary OA, rheumatoid arthritis, chronic inflammatory
- •disease (e.g., colitis) or fibromyalgia
- •5. History of asthma, hypertension, myocardial infarction, thrombotic
- •events, stroke, congestive heart failure, impaired renal function or liver
- •6. History of gastrointestinal (GI) bleeding or peptic ulcer disease Known allergy to aspirin or NSAID
- •8. Elevated transaminases at screening (i.e., AST or ALT more than 2
- •times the upper limit of normal at screening visit)
- •9. Use of anticoagulants, ACE-inhibitors, cyclosporine, diuretics, lithium,
- •or methotrexate within the past 30 days prior to entry into the study
- •10. Concomitant acetyl salicylic acid therapy other than a stable low dose
- •used for cardiac prophylaxis (max 162 mg daily) taken for at least 3
- •months prior to enrolment and maintained throughout the duration of
- •11. Any other topical products applied to the target site
- •12. Use of systemic corticosteroid or immunosuppressive drugs
- •13. Use of pain medication other than acetaminophen / paracetamol
- •14. Any other acute or chronic illness that in the opinion of the investigator
- •could compromise the integrity of the study data or place the subject at
- •risk by participating in the study
- •15. Receipt of any drug as a part of a research within 30 days prior to
- •16. Previous participation in this study
- •17. Recent history of knee injury or surgery
- •18. Subjects who are alcohol or drug dependent i.e. substance of abuse
- •19. Subjects having clinically significant liver, kidney, or cardiac
- •dysfunction
- •20. Subjects having history of hypersensitivity reactions to diclofenac
- •sodium gel or any of its excipients
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