A single-arm, multicentric, open-label clinical study to evaluate the efficacy and safety of â??Nimulid Strong Gel (Diclofenac Diethylamine, Methyl Salicylate, and Menthol)â?? topical analgesic gel in subject suffering from pain associated with recent muscle or joint injuries such as sprains, strains, or sports injuries.

Mankind Pharma Limited0 个研究点目标入组 60 人开始时间: 待定最近更新: 2023年5月29日

试验速览

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•1) Male or Female subject age between 18-65 years (both inclusive)
•2) Subject suffering from pain associated with recent muscle or joint injuries such as sprains, strains, or sports injuries within 24 hours of
•3) Pain Intensity score of >=5 on an 11-point NRS, at rest or during movement unilateral grade I or II acute sprain.
•4) Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
•5) Females of childbearing potential, using an effective contraceptive method for at least one month before the beginning of the study, and willing to use throughout the study.

•1) Subject has treated the pain with treatment such as oral or other topical pain relief medications, massage or physical therapy since experiencing the sprain, strains, or sports injuries.
•2) Acute or chronic pain disorders, which may confound the study pain evaluations
•3) Subject noted to have grade III sprain or fracture
•4) Subjects having recent history (within one year) of alcohol or other substance abuse as
•determined by medical history.
•5) More than one injuries on same limb.
•6) Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.
•7) Previous participation in similar study with similar products within 30 days.
•8) Subject has any visible skin disease at the site of application that, in the opinion of the
•investigator, will interfere with the skin assessments.
•9) Subject has current or relevant previous history of serious, severe or unstable physical
•or psychiatric illness, or medical disorders, such as current or previous history of hepatic or renal diseases (impairment) or peptic ulcer as determined by medical history.
•10) Subject has a history of hypersensitivity (e.g. asthma, bronchospasm, rhinitis, urticarial,
•nasal polyps), allergy, intolerance or contraindication to aspirin, diclofenac, other non-steroidal anti-inflammatory drugs (NSAIDs), menthol or any of the excipients in the test product(s).
•11) Pregnant and breastfeeding women.

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