Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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16 December 2017 |
Main ID: |
NCT02290821 |
Date of registration:
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11/11/2014 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Compared to Placebo in Subjects With Acute Blunt Trauma Injuries
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Scientific title:
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A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Diclofenac Sodium Topical Gel (DSG) 1% Applied Four Times Daily in Subjects With Acute Blunt Soft Tissue Injuries/Contusions of the Limbs |
Date of first enrolment:
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December 2014 |
Target sample size:
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215 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT02290821 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 3
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Countries of recruitment
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United States
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Key inclusion & exclusion criteria
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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
Age minimum:
16 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Acute Blunt Soft Tissue Injuries/Contusions
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Intervention(s)
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Drug: Placebos
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Drug: placebo
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Primary Outcome(s)
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Sum of Pain Intensity Differences Over 24 Hours After Initiating Treatment (SPID 24)
[Time Frame: 24 hours]
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Secondary ID(s)
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197-P-322
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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