Acute Pain Clinical Trial
— PROGELOfficial title:
Randomized, Double-Blind, Parallel, Phase III Superiority Clinical Trial to Evaluate the Efficacy and Safety of Ibuprofen Gel Compared With Placebo in the Treatment of Acute Musculoskeletal Pain
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.
Status | Not yet recruiting |
Enrollment | 300 |
Est. completion date | July 2023 |
Est. primary completion date | May 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Brainfarma Industria Química e Farmacêutica S/A |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Occurrence of adverse events (AEs) during the study period. | Rate of occurrence of serious and non-serious AEs, related and unrelated to treatment groups throughout the clinical trial. | Through study completion, an average of 7 days | |
Primary | Superiority of ibuprofen gel over placebo in the treatment of acute musculoskeletal pain. | The primary endpoint of the study is the proportion of participants achieving at least 50% pain reduction on day 5 of treatment by assessing pain intensity using the Visual Analog Scale (VAS), compared to baseline VAS. (Scale = 0 to 10; 0 = mild pain and 10 = severe pain) | 5 days of treatment | |
Secondary | Pain relief with study medication on days 3, 5, and 7. | Pain relief by the adapted Pain Relief (PAR) Scale, with the 5 categories: 0 - no relief, 1- slight relief, 2 - moderate relief, 3 - considerable relief, and 4 - complete relief, on days 3, 5, and 7. | 3, 5 and 7 days of treatment | |
Secondary | Interference of pain on physical activity on days 3, 5 and 7 | Pain interference with physical activity by 4-point scale: 0 - no interference with physical activity; 1 - no restriction of physical activity, although some pain on movement; 2 - some restriction of physical activity, but not enough to prevent normal activity; 3 - unable to perform normal activities and with substantial limiting effects, on days 3, 5, and 7. | 3, 5 and 7 days of treatment | |
Secondary | Time needed for pain improvement. | Time needed for pain improvement (reduction of at least 50% of pain on the VAS scale) | Through study completion, an average of 7 days | |
Secondary | Obtain the overall assessment of effectiveness, performed by the participant at the end of the treatment. | Overall assessment of treatment by participant using 5-point scale: bad, fair, good, very good, and excellent. | Through study completion, an average of 7 days | |
Secondary | Obtain the overall efficacy evaluation, performed by the investigator at the end of the treatment. | Overall assessment of treatment by physician using 5-point scale: bad, fair, good, very good, and excellent. | Through study completion, an average of 7 days | |
Secondary | Number of participants using rescue medication. | Through study completion, an average of 7 days | ||
Secondary | Time to use of rescue medication. | Through study completion, an average of 7 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04484610 -
Appropriate Opioid Quantities for Acute Pain - Pharmacist Study
|
Phase 4 | |
Recruiting |
NCT05054179 -
Pecto-Intercostal Fascial Plane Block Catheter Trial for Reduction of Sternal Pain
|
Phase 2/Phase 3 | |
Completed |
NCT04548635 -
VR for Burn Dressing Changes at Home
|
Phase 2/Phase 3 | |
Recruiting |
NCT05370404 -
Prescribing vs. Recommending Over-The-Counter (PROTECT) Analgesics for Patients With Postoperative Pain:
|
N/A | |
Completed |
NCT06054945 -
Clinical Impact of IPACK Block Addition to Suprainguinal Fascia Iliaca Block
|
||
Completed |
NCT03825549 -
A Randomized Trial of Behavioral Economic Approaches to Reduce Unnecessary Opioid Prescribing
|
N/A | |
Completed |
NCT05995912 -
Efficacy and Safety of Etoricoxib-tramadol Tablet in Acute Postoperative Pain
|
Phase 2 | |
Recruiting |
NCT05589246 -
Regional Analgesia in Combination With Cryoanalgesia to Prevent Acute Pain Following Nuss Procedure
|
N/A | |
Recruiting |
NCT05572190 -
Evaluate the Safety and Pharmacokinetic Profile of ETR028 and ETR029 in Healthy Adult Subjects
|
Phase 1 | |
Terminated |
NCT04716413 -
Evaluating the Use of Sublingual Sufentanil in Patients With Suboxone Treatment
|
Phase 4 | |
Active, not recruiting |
NCT03537573 -
Provider-Targeted Behavioral Interventions to Prevent Unsafe Opioid Prescribing for Acute Pain in Primary Care
|
N/A | |
Not yet recruiting |
NCT06317844 -
Examination of Psychological and Physiological Pathways Linking Gratitude and Pain
|
N/A | |
Withdrawn |
NCT02957097 -
Gabapentin as a Pre-emptive Analgesic in Oral and Maxillofacial Surgical Procedures
|
Phase 4 | |
Terminated |
NCT02599870 -
Clinical Study to Evaluate Clinical Impact of PGx-Guided Treatment for Patients Undergoing Elective Spinal Surgical Procedures
|
N/A | |
Completed |
NCT02565342 -
Interscalene Brachial Plexus Block to Treat Pain After Clavicular Surgery
|
Phase 4 | |
Completed |
NCT02984098 -
40% Orally Administered Dextrose Gel is More Effective Than 25% Dextrose
|
Phase 4 | |
Completed |
NCT02380989 -
Integrative Ayurveda Healing Relieves Minor Sports Injury Pain
|
Phase 2 | |
Completed |
NCT02489630 -
Low Dose Ketamine as an Adjunct to Opiates for Acute Pain in the Emergency Department
|
Phase 4 | |
Completed |
NCT03107338 -
Preventive Treatment of Pain After Dental Implant Surgery
|
Phase 4 | |
Completed |
NCT02817477 -
Intranasal Ketamine for Acute Traumatic Pain
|
Phase 4 |