None listed
Conditions
Interventions
Group 1 Type of group
Topical diclofenac patch applied once daily to area of pain
Group name:Group 2 Type of group
Matching placebo patch, containing identical constituents to the active comparator except for diclofenac sodium
applied once daily
Sponsors
CERIMON PHARMACEUTICALS, INC.,
Eligibility
Sex/Gender
All
Age
17 Years to 75 Years
Inclusion criteria
Inclusion criteria: • Subjects male or female 17 to 75 years old • They suffered a mild to moderate unilateral painful ankle sprain no more than 60 hours before randomization. • Presence of pain of at least 50 points and not greater than 90 points on a Visual Analog Scale (VAS) 100 points at randomization • 4 Ability and desire to comply with all procedures defined in the protocol including the filling of an electronic journal every day
Exclusion criteria
Exclusion criteria: • Open wound or infection at the site of ankle pain, or evidence of severe injury including fracture or injury to a nerve • Presence of any acute or chronic pain in addition to the ankle specified in the study eg. pain present due to concurrent injury occurred at the time of the sprain or a chronic condition such as osteoarthritis or gout, etc. • Severe ankle sprain or bilateral sprain • Previous injury to the same ankle within 3 months of the current injury • Active skin disease that includes the potential site of patch application • Use of aspirin (except for stable low dose prophylaxis, if started before the injury) or short-lived NSAIDs within 12 hours prior to randomization, or use of NSAIDs with a longer half-life within 24 hours before randomization • Use of systemic opioids within 24 hours prior to randomization, or use of topical opioids within 12 hours prior to randomization • Use of oral or parenteral corticosteroid medications within 30 days prior to randomization • Topical treatment (including physical therapy), other than RISE in English for rest, package. ice compression and simple elevation) applied in the region of pain within hours of randomization. • History of ulcerative peptic disease within one year of randomization, any history of gastrointestinal bleeding or coagulation abnormality (with the exception of bleeding due to internal or external hemorrhoids) • Clinically significant pulmonary, gastrointestinal, hepatic, renal, endocrine or cardiovascular disease, poorly controlled • History of intolerance or hypersensitivity including asthma, after taking aspirin or another nonsteroidal anti-inflammatory drug (NSAID) including Diclofenac • History of acetaminophen intolerance (study rescue medication) • History of skin sensitivity to adhesives (eg adhesive tape) • Treatment with a drug or experimental device within 30 days prior to randomization • Positive urine pregnancy test in women of childbearing age • Positive urine test for drugs of abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:For each subject, the percentage of improvement will be calculated as the negative value of the change in the percentage of the Baseline assessment in the average pain during daily activities, as assessed in a validated 100-point VAS, on Day 3 (the average value of pain assessments in the morning and at night on that day). Measure:Change in average pain during daily activity at Day 3 Timepoints:Day 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The average value of morning and night pain assessments for that day will be used to calculate the percentage change since the baseline assessment. The covariance analysis model (ANCOVA) includes treatment as a factor and the baseline pain score, evaluated by the subjects on a 100-point VAS scale validated in the Baseline assessment (50-70 points versus 71-90 points) as covariate Measure:Percentage change since the baseline evaluation of the average and most severe pain during daily activities, evaluated on a VAS of 100 points validated on Days 3 and 7 Timepoints:Days 3 and 7 ; Outcome name:A Wilcoxon rank test (Mann-Whitney) similar to the primary analysis method described at the beginning of this section will be used Measure:The percentage improvement over average pain in daily activities, as assessed using a validated 100 point VAS, on Day 7, using a response analysis Timepoints:Day 7 ; Outcome name:The percentage change since the evaluation bases! It will be based on pain assessments by subjects twice a day from Day 0 to Day 7. The generalized linear mixed model includes the percentage change of the baseline evaluation such as outcome, treatment, study day and time of day (time point) , treatment * as factors, baseline VAS score (50 - 70 points versus 71 - 90 points) as covariate, time order by day as repeated measurement within the subjects, assuming an unstructured covariance structure. Measure:Percentage change from baseline assessment in average pain during daily activities, assessed on a 100 point VAS validated during the treatment period Timepoints:from Day 0 to Day 7 ; Outcome name:Pearsons Chi-square test or Fishers accuracy test will be used. Measure:Proportion of patients with> 30%,> 50% and> 70% reduction in average pain during daily activities on Day 3 and 7 Timepoints:Day 3 and 7 ; Outcome name:Kaplan Meier method with a log rank test Measure:Time of application of the firs | — |
Countries
United States
Contacts
Public ContactLuis Miguel Miguel
PPD Peru S.A.C.
Outcome results
None listed