Back to resultsEfficacy and Safety of Diclofenac Sodium Topical Gel 1% Applied Four Times Daily in Subjects With Acute Blunt Trauma Injuries
Primary Purpose
Acute Blunt Soft Tissue Injuries/Contusions
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Diclofenac sodium
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Acute Blunt Soft Tissue Injuries/Contusions focused on measuring Blunt soft tissue injury/contusion
Eligibility Criteria
Inclusion Criteria:
- Male or female aged 18 years and over.
- Fresh impact injury (blunt, traumatic soft tissue injury or contusion) of the upper or the lower limbs, not requiring admittance to hospital, meeting baseline pain intensity level.Anticipated time between injury and treatment must be less than 3 hours.
Exclusion Criteria:
- Pain medication was taken within the 6 hours that precede randomization.Any physical impairment that would influence the study's efficacy evaluations, in particular POM such as: peripheral or central neurological disease, significant back pain; in case of acute blunt soft tissue injuries of the lower limbs: symptomatic osteoarthritis of the hips, knees, or feet, or any other painful conditions of the lower extremities (e.g., painful nail, wound, corn, or wart), in case of acute blunt soft tissue injuries of the upper limbs: no painful conditions of the upper extremities.
Sites / Locations
- NCH investigative site
- NCH investigative site
- NCH investigative site
- NCH investigative site
- NCH investigative site
- NCH investigative site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Diclofenac sodium topical gel 1%
placebo
Arm Description
Outcomes
Primary Outcome Measures
Pain on Movement
Visual analog scale (VAS) assessed on a 100 mm scale with anchors at 0= "No pain" and 100= "Extreme pain"
Secondary Outcome Measures
Onset of Pain Relief
Onset of perceptible pain relief.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01272947
Brief Title
Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Applied Four Times Daily in Subjects With Acute Blunt Trauma Injuries
Official Title
A Randomized, Double-blind, Multi-center, 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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy of DSG 1% compared with placebo applied four times a day in subjects with acute blunt soft tissue injuries/contusions of the limbs
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Blunt Soft Tissue Injuries/Contusions
Keywords
Blunt soft tissue injury/contusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
204 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diclofenac sodium topical gel 1%
Arm Type
Experimental
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Diclofenac sodium
Intervention Description
Topical gel 1%- 4 times daily
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Topical gel - 4 times daily
Primary Outcome Measure Information:
Title
Pain on Movement
Description
Visual analog scale (VAS) assessed on a 100 mm scale with anchors at 0= "No pain" and 100= "Extreme pain"
Time Frame
VAS Score at 24 hours
Secondary Outcome Measure Information:
Title
Onset of Pain Relief
Description
Onset of perceptible pain relief.
Time Frame
From randomization to end of day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female aged 18 years and over.
Fresh impact injury (blunt, traumatic soft tissue injury or contusion) of the upper or the lower limbs, not requiring admittance to hospital, meeting baseline pain intensity level.Anticipated time between injury and treatment must be less than 3 hours.
Exclusion Criteria:
Pain medication was taken within the 6 hours that precede randomization.Any physical impairment that would influence the study's efficacy evaluations, in particular POM such as: peripheral or central neurological disease, significant back pain; in case of acute blunt soft tissue injuries of the lower limbs: symptomatic osteoarthritis of the hips, knees, or feet, or any other painful conditions of the lower extremities (e.g., painful nail, wound, corn, or wart), in case of acute blunt soft tissue injuries of the upper limbs: no painful conditions of the upper extremities.
Facility Information:
Facility Name
NCH investigative site
City
Brühl
Country
Germany
Facility Name
NCH investigative site
City
Butzbach
Country
Germany
Facility Name
NCH investigative site
City
Cologne
Country
Germany
Facility Name
NCH investigative site
City
Essen
Country
Germany
Facility Name
NCH investigative site
City
Gilching
Country
Germany
Facility Name
NCH investigative site
City
Munich
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Applied Four Times Daily in Subjects With Acute Blunt Trauma Injuries
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