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New treatment option for Musculoskeletal Injury
Official title Topical Diclofenac vs.Oral Ibuprofen for MSK Pain in Children
ClinicalTrials.gov ID: NCT07145645
What this study is testing
What is Voltaren Topical Gel?
Voltaren Topical Gel is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for musculoskeletal injury.
Also referred to as diclofenac emulgel, diclofenac diethylamine.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The TOP-MAP pilot trial has multiple goals. The first goal of this pilot clinical trial is to find out if it will be possible to carry out a study at multiple pediatric emergency department sites (Peds ED) comparing Non-Steroidal Anti-Inflammatory (NSAID) gel applied to a new ankle or knee injury to NSAIDs taken by mouth in kids aged 6-18.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 18
You may be able to join if
- Age 6 to 18 years old.
- Injury less than or equal to 4 days old
- Non-fractured MSK soft-tissue injury (ankle or knee, confirmed clinically and/or radiographically)
- Pain score of more than or equal to 3 on the verbal numerical rating scale, with movement in the past 2 hours or before analgesia
- Willing and able to complete follow-up surveys as per study protocol
You likely can't join if
- Previous enrolment in the trial
- Barriers to topical treatment application, including skin conditions (e.g. eczema, infection, open wounds) or overlying material (e.g., rigid cast)...
- Any other history, condition, therapy, or uncontrolled intercurrent illness, which could, in the opinion of the Qualified Medical Investigator or...
- Any contraindication to NSAID use including but not limited to a history of GI bleeding, gastric ulcer, inflammatory bowel disease, prior...
- Taking NSAIDs daily for other indications (e.g, chronic pain or arthritis)
- Known hypersensitivity to ibuprofen, diclofenac or other NSAIDs.
See the full eligibility criteria
- Age 6 to 18 years old.
- Injury less than or equal to 4 days old
- Non-fractured MSK soft-tissue injury (ankle or knee, confirmed clinically and/or radiographically)
- Pain score of more than or equal to 3 on the verbal numerical rating scale, with movement in the past 2 hours or before analgesia
- Willing and able to complete follow-up surveys as per study protocol
- Previous enrolment in the trial
- Barriers to topical treatment application, including skin conditions (e.g. eczema, infection, open wounds) or overlying material (e.g., rigid cast) which would make applying topical treatment impossible.
- Any other history, condition, therapy, or uncontrolled intercurrent illness, which could, in the opinion of the Qualified Medical Investigator or treating physician, would make the participant unsuitable for this study
- Any contraindication to NSAID use including but not limited to a history of GI bleeding, gastric ulcer, inflammatory bowel disease, prior cerebrovascular bleeding, bleeding diathesis, interstitial kidney disease
- Taking NSAIDs daily for other indications (e.g, chronic pain or arthritis)
- Known hypersensitivity to ibuprofen, diclofenac or other NSAIDs.
- Any known allergy or intolerance to any components or trace constituents (e.g., aloe vera, tree nuts or corn) of the investigational products
- Current use of prohibited medications known to impair renal function when combined with NSAIDs or cause potential additive risks of gastrointestinal toxicity and renal impairment
- Absence of a parent/guardian for children who are not mature minors.
- Caregiver and/or child cognitive impairment precluding the ability to complete study procedures
- Inability to obtain consent, and to complete follow-up surveys due to language barrier
- Known or suspected late pregnancy (gestational age ≥20 weeks) at the time of enrolment or breastfeeding females, due to the risk of premature closure of the ductus arteriosus associated with NSAID use
- Current enrollment in another pain-related clinical trial or in a study that, in the opinion of the Qualified Medical Investigator, may interfere with enrollment, involve investigational products that interact with...
The study team makes the final eligibility decision.
Where it's taking place
- Calgary, Alberta, Canada
- Edmonton, Alberta, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Calgary, Alberta, Canada; Edmonton, Alberta, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.