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Topical Diclofenac for Headaches

(DITCH Trial)

GW
DT
CV
Overseen ByCristian Villegas, MD
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

The intervention will consist of the nursing staff applying 2 grams of diclofenac 1% gel topically to the posterior cervical region four times daily. The control group will receive petroleum jelly topically to the posterior cervical region four times daily. Patients will receive a pre-intervention and post-intervention survey incorporating the Numeric Assessment Scale and Headache Impact Test-6.

Do I have to stop taking my current medications for this trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on dual antiplatelet therapy or have certain conditions like chronic pain managed with continuous opioids.

What safety data exists for topical diclofenac treatments?

Topical diclofenac treatments, such as gels and patches, have been studied for various conditions including sunburn, osteoarthritis, and localized pain. Studies show that these treatments are generally well-tolerated with mild adverse effects like pruritus, paresthesia, and application-site reactions. Serious adverse events are rare. Diclofenac sodium 1% gel, for example, provides effective pain relief with limited systemic exposure and a low incidence of systemic adverse events. Diclofenac epolamine patches also show good tolerability and effectiveness for mild-to-moderate pain.12345

Is Diclofenac Gel a promising drug for headaches?

Diclofenac Gel is promising because it effectively reduces pain and inflammation, as shown in studies where it relieved sunburn pain quickly and had a lasting effect. It also has a good safety profile with minimal side effects.12367

What data supports the idea that Topical Diclofenac for Headaches is an effective drug?

The available research shows that topical diclofenac gel is effective in reducing pain and inflammation, but the studies focus on conditions like sunburn and psoriatic arthritis rather than headaches. For sunburn, diclofenac gel significantly reduced pain and redness, with effects lasting up to 48 hours. In psoriatic arthritis, it was preferred over other anti-inflammatory drugs by most patients. However, there is no specific data provided on its effectiveness for headaches compared to other treatments.138910

Who Is on the Research Team?

DT

Duc Tran, MD, PhD

Principal Investigator

Loma Linda University

Are You a Good Fit for This Trial?

This trial is for adults aged 18-90 who are hospitalized with cervicogenic headaches, can consent for themselves, and speak English or Spanish. Excluded are those on chronic opioid regimens, pregnant women, patients with fibromyalgia or cervical spine procedures history, primary headache from intracranial pathology, known diclofenac sensitivity, recent nerve blocks or steroid injections.

Inclusion Criteria

I have headaches due to a neck condition.
Hospitalized at Loma Linda East Campus Rehabilitation Hospital
Subject must be able to consent for themselves

Exclusion Criteria

I was discharged from acute rehab in less than 14 days.
I haven't had nerve blocks in the last 4 weeks or steroid injections in the last 6 months.
My headaches are caused by a brain tumor.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Nursing staff apply 2 grams of diclofenac 1% gel or petroleum jelly topically to the posterior cervical region four times daily for 14 days. Surveys and metabolic panels are conducted at baseline, day 7, and day 14.

2 weeks
3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Diclofenac Gel
Trial Overview The study tests the effectiveness of diclofenac gel versus petroleum jelly in treating cervicogenic headaches. Participants will apply either diclofenac gel or petroleum jelly to their neck four times daily. Their headache severity before and after treatment will be measured using surveys.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Diclofenac GelExperimental Treatment1 Intervention
Group II: ControlPlacebo Group1 Intervention

Diclofenac Gel is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Voltaren for:
🇪🇺
Approved in European Union as Voltaren for:
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Approved in Canada as Voltaren for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Loma Linda University

Lead Sponsor

Trials
322
Recruited
267,000+

Published Research Related to This Trial

A 0.1% diclofenac-Na Emulgel significantly alleviated pain and reduced symptoms like erythema and oedema in sunburned skin, showing efficacy when applied 6 and 10 hours after UV exposure.
A single application of the gel provided pain relief within 2 hours and maintained symptom reduction for up to 48 hours, demonstrating its effectiveness as a treatment for sunburn.
Diclofenac-Na gel is effective in reducing the pain and inflammation associated with exposure to ultraviolet light - results of two clinical studies.Kienzler, JL., Magnette, J., Queille-Roussel, C., et al.[2013]
In a study of 467 adults using over-the-counter Voltaren gel (diclofenac), participants reported a significant reduction in pain severity, improving by an average of 1.2 points on a scale of 0 to 10 after 12 weeks of treatment.
The majority of users, particularly those aged 65 and older, showed high satisfaction with the treatment and rarely switched to other topical therapies, indicating that Voltaren gel is a well-tolerated option for managing musculoskeletal pain.
Patients' experience and utilization patterns of diclofenac gel in Germany: a real-world study with a prospective longitudinal survey and a retrospective analysis of pharmacy data.Maihöfner, C., de Haas, A., Sethi, V., et al.[2023]
In a clinical trial involving 172 subjects with first-degree sunburn, diclofenac-Na 0.1% gel significantly reduced pain intensity and erythema compared to a placebo gel, with effects noticeable within hours and peaking at 30 hours post-application.
The treatment was well-tolerated, with only mild and infrequent side effects reported, indicating that diclofenac-Na gel is a safe option for managing pain and discomfort from sunburn.
The efficacy and safety of low-dose diclofenac sodium 0.1% gel for the symptomatic relief of pain and erythema associated with superficial natural sunburn.Magnette, J., Kienzler, JL., Alekxandrova, I., et al.[2013]

Citations

Diclofenac-Na gel is effective in reducing the pain and inflammation associated with exposure to ultraviolet light - results of two clinical studies. [2013]
Patients' experience and utilization patterns of diclofenac gel in Germany: a real-world study with a prospective longitudinal survey and a retrospective analysis of pharmacy data. [2023]
The efficacy and safety of low-dose diclofenac sodium 0.1% gel for the symptomatic relief of pain and erythema associated with superficial natural sunburn. [2013]
Diclofenac sodium, 0.1% (Voltaren Ophtha), versus sodium chloride, 5%, in the treatment of filamentary keratitis. [2019]
5.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[The efficacy of diclonate P in psoriatic arthritis]. [2013]
Photoallergic contact dermatitis from topical diclofenac in Solaraze gel. [2013]
Topical therapy for osteoarthritis: clinical and pharmacologic perspectives. [2013]
Diclofenac epolamine topical patch for the treatment of pain. [2019]
Efficacy and safety of diclofenac diethylamine 2.32% gel in acute ankle sprain. [2013]
Topical diclofenac solution. [2021]
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