CTRI/2020/10/028642尚未招募3 期
A Phase III, Multicenter, Randomized, Open Label, Parallel Group, Comparative Clinical Study To Evaluate The Efficacy And Safety of Aceclofenac Topical Ointment 1.5% w/w with Voveran Emulgel® (Diclofenac Sodium 1.0% w/w) For The Treatment of Acute Musculoskeletal Conditions
Panacea Biotec Pharma Ltd0 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
- 3 期
- 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
- •Subjects must meet all of the following criteria to be considered for enrollment in the study:
- •1.Male or non-pregnant female patients aged between 18-65 years with a clinical diagnosis of acute musculoskeletal conditions.
- •2.Patients with single site painful acute musculoskeletal conditions (tendinitis, bursitis, myalgia, low back-ache, sprains, pulled muscle, localized painful swelling etc.) sustained within 48 hours of screening (not requiring surgical treatment).
- •3.Patients with at least moderate pain at rest of Numeric rating Scale (NRS) greater or equal to 4.
- •4.Patient is able to provide written informed consent prior to study.
- •5.Willingness to comply with the study schedule and procedures.
- •6.If female, patient must be either postmenopausal for at least one year prior to randomization, surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or practicing the following methods of birth control:
- •a) Oral Contraceptives or Intrauterine Device in place for at least 3 months prior to the start of the study and remaining in place during the study period, or
- •b) Double Barrier methods containing or used in conjunction with a spermicidal agent, or
- •c) Contraceptive Patches/ Implants, or
- •d) Abstinence: Subjects who will be practicing abstinence will agree to have an acceptable method of birth control if the subject becomes sexually active during the course of her study participation.
- •7. All male subjects must agree to use accepted methods of birth control with their partners during the study. Abstinence is an acceptable method of birth control. Any of the following methods of birth control are acceptable: oral contraceptives, contraceptive patches/implants (e.g., Norplant®), Depo-Provera®, double barrier methods (e.g., condom and spermicide) or IUD.
排除标准
- •Subjects meeting any of the following criteria must be excluded from enrollment in the study:
- •1. Patients with any condition which in opinion of the investigator
- •makes the patient unsuitable for inclusion.
- •2. Patients with painful muscle spasms associated with
- •musculoskeletal systems, which need parenteral therapy / surgery / hospital admission for management.
- •3. Patient with history of osteoarthritis / rheumatoid arthritis.
- •4. Patients with skin wounds, open injuries or other conditions of
- •broken skin at the site of proposed application.
- •5. Use of any oral or topical analgesic or anti-inflammatory treatment within 1 week prior to study screening.
- •6. Patients with history of severe cardiac, hepatic, gastrointestinal,
- •renal, pulmonary and skin diseases.
- •7. Known hypersensitivity to Aceclofenac or any other ingredient of product or to rescue medication acetaminophen (Paracetamol).
- •8. Patient is a female who is pregnant or willing to get pregnant, not
- •ready to use contraceptive measures during the trial period or breast feeding.
- •9. Participation in any other clinical trial during last 90 days.
- •10. History of regular fever, headaches which warrants frequent use of acetaminophen (Paracetamol) or NSAIDS
- •11. Elevated transaminases (>= 3 times ULN) and hemoglobin < 9.0 g/dl at screening.
研究者
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