Phase 3
N=215
Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Compared to Placebo in Subjects With Acute Blunt Trauma Injuries
Acute Blunt Soft Tissue Injuries/Contusions
Bottom Line
View on ClinicalTrials.gov: NCT02290821 ↗Enrolled (actual)
215
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: Sum of Pain Intensity Differences Over 24 Hours After Initiating Treatment (SPID 24) — 42.9; 45.5 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- placebo (Drug); Placebos (Drug)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- Novartis
- Primary completion
- Sep 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sum of Pain Intensity Differences Over 24 Hours After Initiating Treatment (SPID 24) |
42.9; 45.5 | — |
Summary
This study will assess the analgesic efficacy of DSG 1% compared to placebo in the reduction of the pain associated with acute blunt trauma injuries.
Eligibility Criteria
Inclusion Criteria
- Male or female subjects aged 16 years and over Fresh impact injury of the upper or lower limbs, not requiring admittance to hospital & meeting baseline pain intensity level Anticipated time between injury and treatment must be ≤ 6 hours
Exclusion Criteria
- Pain medication prior to randomization Topical analgesic or anti-inflammatory treatment over the previous month in the area to be treated Any physical impairment that would influence efficacy assessments, such as peripheral or central neurological disease, significant back pain, painful conditions of the upper or lower extremities Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT02290821). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.