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

• Status: Not yet recruiting
• Trial end date: 2023-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Phase III clinical trial, multicentre of superiority, randomized, double-blind, parallel groups, placebo-controlled and use of ibuprofen gel in the treatment of acute pain.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brainfarma Industria Química e Farmacêutica S/A
• Treatments: Ibuprofen

Criteria

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 limb contusions, 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 truly abstinent 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 of treatment;

• Agree to safety laboratory tests: pregnancy test, complete blood count, and biochemical profile;

• Be able to understand the nature and purpose of the trial, including the risks and adverse 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 related compounds;

• Have a prior history of the following comorbidities: asthma or other allergic conditions, 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 Health Organization;

• 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 as non-steroidal anti-inflammatory drugs (NSAIDs), warfarin, lithium, methotrexate, acetylsalicylic acid, corticosteroids, oral hypoglycemic agents, beta blockers, angiotensin-converting enzyme inhibitors, antihypertensive agents, and diuretics such as furosemide or thiazide;

• Have had oral or topical analgesic treatment, including use of non-steroidal analgesics, 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 test positive 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's judgment.