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 Ltd5 个研究点 分布在 1 个国家目标入组 186 人开始时间: 2020年10月30日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 186
- 试验地点
- 5
- 主要终点
- Pain intensity at rest (Based on NRS)
研究概览
简要总结
This is a Phase III, Multicenter, Randomized, Open Label, Parallel Group, Comparative Clinical Study to evaluate the efficacy and safety of test product Aceclofenac topical ointment 1.5% w/w of Panacea Biotec Ltd. with comparator Voveran Emulgel® (Diclofenac Sodium1.0% w/w) gel of Novartis India Ltd. for the treatment of acute musculoskeletal conditions.Around 186 subjects will be randomized in this study (Including 20% drop outs), 93 subjects in each treatment arm & all subjects will have to apply 2 gm of study treatment topically to the affected area 2 times daily for 8 days.
Efficacy of the study drug will be measured by in terms of pain intensity, overall clinical response and need for the rescue medications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
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.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.
- •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:
- •Patients with any condition which in opinion of the investigator makes the patient unsuitable for inclusion.
- •Patients with painful muscle spasms associated with musculoskeletal systems, which need parenteral therapy / surgery / hospital admission for management.
- •Patient with history of osteoarthritis / rheumatoid arthritis.
- •Patients with skin wounds, open injuries or other conditions of broken skin at the site of proposed application.
- •Use of any oral or topical analgesic or anti-inflammatory treatment within 1 week prior to study screening.
- •Patients with history of severe cardiac, hepatic, gastrointestinal, renal, pulmonary and skin diseases.
- •Known hypersensitivity to Aceclofenac or any other ingredient of product or to rescue medication acetaminophen (Paracetamol).
- •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.
- •Participation in any other clinical trial during last 90 days.
- •History of regular fever, headaches which warrants frequent use of acetaminophen (Paracetamol) or NSAIDS
- •Elevated transaminases (≥ 3 times ULN) and hemoglobin < 9.0 g/dl at screening.
结局指标
主要结局
Pain intensity at rest (Based on NRS)
时间窗: Time frame: Baseline to day 8
次要结局
- 1.Overall clinical response based on 50% relief in patient pain.(2.Pain intensity at rest (Based on NRS).)
研究者
研究点 (5)
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