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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Musculoskeletal Pain; Acute Pain; Sprains; Stretch
• Intervention / Treatment: Drug: Ibuprofen gel; Other: Placebo

Detailed Description

This study is designed for the relief of acute musculoskeletal pain, characterized by pain in muscles, ligaments, tendons, and nerves.

It is performed in participants of both sexes, over 18 years of age, who have pain of moderate intensity as a result of ankle sprains, upper limb contusions, thigh muscle strains, or torticollis.

The rationale for studying the topical use of ibuprofen is the possibility of an alternative treatment for musculoskeletal pain, avoiding systemic adverse events caused by oral administration.

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Cosmed Indústria de Cosméticos e Medicamentos S/A; Phone Number: 5511 45072111; Email: juliana.augusto@brainfarma.ind.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Other: Placebo; Placebo gel topically four times a day
EXPERIMENTAL: Ibuprofen gel 5%	Drug: Ibuprofen gel; Ibuprofen gel 5% topically four times a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
Number of participants using rescue medication.		Through study completion, an average of 7 days
Time to use of rescue medication.		Through study completion, an average of 7 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Brainfarma Industria Química e Farmacêutica S/A
• Investigators: Study Director: Brainfarma Indústria Química Farmacêutica, Brainfarma Industria Química e Farmacêutica S/A

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): August 1, 2022
• Primary Completion (ANTICIPATED): May 1, 2023
• Study Completion (ANTICIPATED): July 1, 2023

Study Registration Dates

• First Submitted: August 3, 2021
• First Submitted That Met QC Criteria: August 16, 2021
• First Posted (ACTUAL): August 19, 2021

Study Record Updates

• Last Update Posted (ACTUAL): March 21, 2022
• Last Update Submitted That Met QC Criteria: March 17, 2022
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: pain; ibuprofen; ibuprofen gel
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Acute Pain; Musculoskeletal Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ibuprofen
• Other Study ID Numbers: HYP 001-21

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No