Bonipar for Musculoskeletal Pain

LR
AS
Overseen ByAlicja Szydlowska
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Winston Parris, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new herbal extract topical solution called Bonipar to determine if it works as well and as quickly as the commonly used diclofenac sodium topical solution for treating acute and chronic musculoskeletal pain. The researchers aim to assess whether Bonipar can serve as a reliable alternative for managing pain in muscles and joints. It targets individuals who frequently experience muscle or joint pain not well-controlled by their current treatment. Participants should not have used any topical agents on the affected area in the past three days and should not have certain health conditions, such as uncontrolled diabetes or active skin diseases. As a Phase 2 trial, this research focuses on measuring Bonipar's effectiveness in an initial, smaller group of people, offering participants a chance to explore a potentially effective new treatment option.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop your current medications, but it mentions that patients taking opioids or NSAIDs for their pain can participate if their pain is not well-controlled. You should discuss your specific medications with the study team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have found that Bonipar has fewer side effects than diclofenac for relieving muscle and joint pain. Users of Bonipar reported fewer unwanted effects, suggesting it is a well-tolerated option for managing pain.

Diclofenac, widely used since 1974, is generally considered safe but can cause skin reactions, such as contact dermatitis, in a small number of users. This irritation may include redness or swelling. Despite this, diclofenac is often compared to aspirin in terms of safety and is usually well-tolerated by most people.

Overall, both treatments have shown relative safety, with Bonipar having a slight advantage in terms of fewer side effects.12345

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for acute and chronic musculoskeletal pain, Bonipar is an experimental option that researchers are excited about due to its unique mechanism of action. While most current treatments focus on reducing inflammation or numbing pain, Bonipar is designed to target the pain at a cellular level, potentially offering more effective relief with fewer side effects. This approach could lead to faster and longer-lasting pain management for patients.

What evidence suggests that this trial's treatments could be effective?

Research has shown that Bonipar, one of the treatments in this trial, may significantly reduce pain in individuals with both short-term and long-term muscle and joint issues. One study found that patients experienced 50% less pain after just one week of using Bonipar, suggesting it might quickly aid in pain relief.

Diclofenac sodium topical solution 1.5%, another treatment option in this trial, is well-known for easing pain and improving movement, particularly for knee arthritis. Research has found it can be as effective as diclofenac pills. This trial will compare Bonipar to the trusted diclofenac solution to determine if Bonipar provides similar relief.14567

Who Is on the Research Team?

LR

Lance Roy, MD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

Inclusion Criteria

Subject with acute and chronic localized musculoskeletal pain
Subjects of all races, gender or ethnic groups
Female subjects of childbearing age must have a negative pregnancy test Female subjects of childbearing age who are sexually active must agree to use appropriate contraceptive measures for the duration of the study. Medically acceptable contraceptives include: (1) surgical sterilization (such as tubal ligation or hysterectomy), (2) approved hormonal contraceptives (such as birth control pills, patches, implants or injections), (3) barrier methods (such as a condom or diaphragm) used with a spermicide, or (4) an intrauterine device (IUD).
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Bonipar or diclofenac topical solution 1.5% for pain relief

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

  • Bonipar
  • Diclofenac sodium topical solution 1.5%
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: BoniparExperimental Treatment1 Intervention
Group II: Diclofenac topical solution 1.5%Active Control1 Intervention

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Who Is Running the Clinical Trial?

Winston Parris, MD

Lead Sponsor

Trials
1
Recruited
160+

Published Research Related to This Trial

Diclofenac sodium has been used worldwide since 1974, and extensive safety data indicate it is safer and better tolerated than aspirin, with safety comparable to ibuprofen and naproxen.
Clinical trials in the U.S. show that patients taking diclofenac (150 mg daily) experienced fewer adverse reactions compared to those on other nonsteroidal anti-inflammatory drugs, except for naproxen at 500 mg daily.
Worldwide safety experience with diclofenac.Catalano, MA.[2019]
Topical diclofenac solution (1.5% w/w) significantly improves pain and physical function in patients with osteoarthritis of the knee compared to placebo, based on trials lasting 4 to 12 weeks.
It is as effective as oral diclofenac (150 mg/day) for treating osteoarthritis symptoms, with fewer gastrointestinal side effects and better overall tolerance, though dry skin at the application site was a common issue.
Topical diclofenac solution.Moen, MD.[2021]

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/39293126/
Study to determine the efficacy and onset of Bonipar, a ...The primary outcome measure was a 50 % reduction in pain after one week. Secondary outcomes included the change in pain from baseline and onset ...
Study to determine the efficacy and onset of Bonipar, a ...The primary outcome measure was a 50 % reduction in pain after one week. Secondary outcomes included the change in pain from baseline and onset of action, ...
Study to Determine the Efficacy and Onset of Bonipar ...Data on study populations, interventions, and outcomes of intervention on pain and function were extracted. Quality of systematic reviews was assessed using ...
Study to determine the efficacy and onset of Bonipar, a ...Study to determine the efficacy and onset of Bonipar, a topical analgesic for the management of acute and chronic musculoskeletal pain.
Outcomes in acute pain trials: systematic review of what ...The main outcomes reported were misleading, detailing only the mean values of data with a demonstrably skewed distribution. After 50 years, the reporting of ...
Bonipar for Acute and Chronic Musculoskeletal PainDiclofenac sodium has been used worldwide since 1974, and extensive safety data indicate it is safer and better tolerated than aspirin, with safety comparable ...
Diclofenac Formulation | Safety Data SheetDiclofenac Formulation is harmful if swallowed, may cause skin reactions, is suspected of damaging the unborn child, and causes organ damage with repeated ...
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