Bonipar for Acute and Chronic Musculoskeletal Pain

Overseen By Alicja Szydlowska

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Winston Parris, MD

Must not be taking: Topical agents, NSAIDs

Disqualifiers: Diabetes, Hypertension, GERD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

164 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the drug Bonipar, Diclofenac sodium topical solution 1.5%?

Research shows that topical diclofenac solutions, like the 1.5% version, are effective in reducing pain and improving physical function in patients with osteoarthritis of the knee. These solutions are generally well tolerated and have fewer gastrointestinal side effects compared to oral diclofenac. ^{1 2 3 4 5}

Is diclofenac sodium topical solution 1.5% safe for humans?

Diclofenac sodium, used worldwide since 1974, has been shown to be generally safe and well-tolerated in humans, with safety comparable to ibuprofen and naproxen. Topical forms, like the 1.5% solution, are considered safer than oral forms due to lower absorption into the body. ^{5 6 7 8 9}

How does the drug Bonipar, Diclofenac sodium topical solution 1.5%, differ from other treatments for this condition?

This drug is unique because it is a topical solution that allows for direct application to the affected area, reducing systemic exposure and potential side effects compared to oral NSAIDs. It contains dimethyl sulfoxide (DMSO) to enhance skin absorption, making it effective for treating osteoarthritis pain in the knee. ^{2 4 10 11 12}

What is the purpose of this trial?

This trial compares a new herbal pain-relief cream (Bonipar) with an existing medicated cream (diclofenac). It targets patients with muscle and joint pain to see if the herbal cream works as well as the medicated one. Diclofenac is commonly used to treat pain and inflammation in conditions such as osteoarthritis, rheumatoid arthritis, and other musculoskeletal disorders.

Research Team

Lance Roy, MD

Principal Investigator

Duke University

Eligibility Criteria

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).

Timeline

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

Treatment Details

Interventions

• Bonipar
• Diclofenac sodium topical solution 1.5%

Participant Groups

Group I: Bonipar Experimental Treatment 1 Intervention

Group II: Diclofenac topical solution 1.5% Active Control 1 Intervention

Who Is Running the Clinical Trial?

Winston Parris, MD

Lead Sponsor

Trials

1

Recruited

160+

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical diclofenac solution. Moen, MD.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Worldwide safety experience with diclofenac. Catalano, MA.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety of topical diclofenac containing dimethyl sulfoxide (DMSO) compared with those of topical placebo, DMSO vehicle and oral diclofenac for knee osteoarthritis. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of diclofenac sodium 2% topical solution for osteoarthritis of the knee: a randomized, double-blind, vehicle-controlled, 4 week study. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Randomized clinical comparisons of diclofenac concentration in the soft tissues and blood plasma between topical and oral applications. [2021]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Topical diclofenac solution. [2021]

5. England pubmed.ncbi.nlm.nih.gov

An open-label, long-term safety and tolerability trial of diclofenac sodium 1% gel in patients with knee osteoarthritis. [2016]

6. England pubmed.ncbi.nlm.nih.gov

Low-dose SoluMatrix diclofenac : a review of safety across two Phase III studies in patients with acute and osteoarthritis pain. [2015]

7. England pubmed.ncbi.nlm.nih.gov

Bioequivalence of diclofenac sodium 2% and 1.5% topical solutions relative to oral diclofenac sodium in healthy volunteers. [2015]

8. United States pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of diclofenac sodium gel in knee osteoarthritis. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Worldwide safety experience with diclofenac. [2019]

10. Germany pubmed.ncbi.nlm.nih.gov

Diclofenac systemic exposure is not increased when topical diclofenac is applied to ultraviolet-induced erythema. [2018]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Rheological and Drug Delivery Characteristics of Poloxamer-Based Diclofenac Sodium Formulations for Chronic Wound Site Analgesia. [2021]

12. England pubmed.ncbi.nlm.nih.gov

Review of the pharmaceutical properties and clinical effects of the topical NSAID formulation, diclofenac epolamine. [2019]