None listed
Conditions
Interventions
Group 1 Type of group
Topical 1% diclofenac sodium patch, applied once daily for 7 days
Group name:Group 2 Type of group
Matching placebo patch, containing identical constituents to the active drug arm except for diclofenac sodium
applied once daily for 7 days
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 sprained, distended or bruised wrist 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) of 100 points validated in randomization • 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 wrist pain, or evidence of severe injury including fracture or nerve injury • Presence of any acute or chronic pain in addition to that of the wrist specified in the study, eg. pain due to concurrent injury that occurred at the time of the sprain, strain or bruise or a chronic condition such as osteoarthritis or gout, etc. • Sprained, distended or bruised wrist or sprained, bilateral distended or bruised • Prior injury, or onset of tendinitis or bursitis on the same wrist within 3 months of the current injury • Presence of tendonitis or bursitis • History of injury or paresis in a nerve of the hand, wrist or forearm (eg carpal tunnel syndrome), in the limb that qualifies for the study • Active skin disease that includes the potential site of patch application • Use of aspirin (except in a stable low-dose cardiovascular prophylaxis regimen, if started before the injury) or short-lived NSAIDs within 12 hours prior to randomization, or use of long-lived NSAIDs 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) applied in the pain region within 12 hours of randomization, other than ice packs or simple compression. • 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 foot 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 drug abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:For each subject, the improvement percentage will be calculated as the negative value of the percentage change of the evaluation Basa! in average pain during daily activities, as assessed in a validated 100-point VAS, on Day 3 Measure:Change in average pain during daily activity 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 the treatment as a factor and the baseline pain score, evaluated by the subjects on a VAS scale of ICO points 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 of improvement over the 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 from the baseline evaluation 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 assessment 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. Measure:Percentage change from baseline assessment in average pain during daily activities, assessed on a 100 point VAS validated during the treatment period Timepoints: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 first patch of the study to a reduction in average | — |
Countries
United States
Contacts
Public ContactLuis Miguel Melendez
PPD Peru S.A.C.
Outcome results
None listed