Efficacy and Safety Study of Ibuprofen Gel Compared to Placebo in the Treatment of Acute Musculoskeletal Pain

Inclusion Criteria:

• Have signed the informed consent form;
• Participants of both genders aged ≥ 18 years;
• Present acute musculoskeletal pain as a result of: ankle sprains, upper limbcontusions, thigh muscle sprains, or torticollis;
• Present pain of moderate intensity by VAS scale (3 ≤ VAS ≤ 7);
• Pain onset time is less than 36 hours;
• Present intact skin at the trauma site;
• Participants of both sexes with the potential to become pregnant must be trulyabstinent or use a highly effective method of contraception throughout the period of 30 days before the administration of the drug until 30 days after the end oftreatment;
• Agree to safety laboratory tests: pregnancy test, complete blood count, andbiochemical profile;
• Be able to understand the nature and purpose of the trial, including the risks andadverse events.

Exclusion Criteria:

• Participants under the age of 18;
• Participants with musculoskeletal pain as a result of fractures or dislocations;
• Participants with mild pain (VAS < 3) at the time of selection;
• Participants with severe pain (VAS > 7) at the time of selection;
• Participants with pain onset time greater than 36 hours;
• Participants with a history of chronic pain and acute pain spikes;
• Participants with loss of skin integrity at the trauma site;
• Have a known hypersensitivity reaction to the trial medication or chemically relatedcompounds;
• Have a prior history of the following comorbidities: asthma or other allergicconditions, uncontrolled heart failure, chronic kidney disease, chronic liver disease,active peptic ulcer disease, or gastrointestinal bleeding;
• Suspect for COVID-19 according to the criteria defined by the World HealthOrganization;
• Regular use of analgesics, non-steroidal analgesics or anticoagulants;
• Use of oral or topical corticoids in the injured area;
• Being on medications that have relevant interactions with the trial drugs, such asnon-steroidal anti-inflammatory drugs (NSAIDs), warfarin, lithium, methotrexate,acetylsalicylic acid, corticosteroids, oral hypoglycemic agents, beta blockers,angiotensin-converting enzyme inhibitors, antihypertensive agents, and diuretics suchas furosemide or thiazide;
• Have had oral or topical analgesic treatment, including use of non-steroidalanalgesics, within 72 hours prior to the screening visit;
• Participants using traditional Chinese or Japanese therapy (acupuncture);
• Abusive use of alcoholic beverages;
• Women who are pregnant, breastfeeding, planning to become pregnant, or who testpositive for pregnancy during the trial period;
• Have participated in a clinical trial within the last 12 months;
• Have any condition that would preclude participation in the trial in the physician'sjudgment.