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

NCT05013567 | Unknown Phase 3

• 1 other identifier: HYP 001-21
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Musculoskeletal Pain; Acute Pain; Stretch; Sprains

Keywords

ibuprofen; ibuprofen gel; pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Pain relief with study medication 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

  3, 5 and 7 days of treatment

• Time needed for pain improvement.

  Through study completion, an average of 7 days

• Obtain the overall assessment of effectiveness, performed by the participant at the end of the treatment.

  Through study completion, an average of 7 days

• Obtain the overall efficacy evaluation, performed by the investigator at the end of the treatment.

  Through study completion, an average of 7 days

Other Outcomes (1)

• Occurrence of adverse events (AEs) during the study period.

  Through study completion, an average of 7 days

Study Arms (2)

Ibuprofen gel 5%

EXPERIMENTAL

Drug: Ibuprofen gel

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Ibuprofen gel DRUG

Ibuprofen gel 5% topically four times a day

Ibuprofen gel 5%

Placebo OTHER

Placebo gel topically four times a day

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);

Sponsors & Collaborators

• Brainfarma Industria Química e Farmacêutica S/A: lead

MeSH Terms

Conditions

Musculoskeletal Pain; Acute Pain; Sprains and Strains; Pain

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Brainfarma Indústria Química Farmacêutica

  Brainfarma Industria Química e Farmacêutica S/A

  STUDY DIRECTOR

Central Study Contacts

Cosmed Indústria de Cosméticos e Medicamentos S/A

CONTACT

5511 45072111; juliana.augusto@brainfarma.ind.br

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2021
• First Posted: August 19, 2021
• Study Start: August 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: July 1, 2023
• Last Updated: March 21, 2022

Record last verified: 2021-08