Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:53 AM
Ignite Modification Date:
2025-12-25 @ 12:53 AM
NCT ID:
NCT05013567
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05013567
Study Brief:
Protocol Section:
NCT05013567