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Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Compared to Placebo in Subjects With Acute Blunt Trauma Injuries

Primary Purpose

Acute Blunt Soft Tissue Injuries/Contusions

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
placebo
Placebos
Sponsored by
Novartis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Blunt Soft Tissue Injuries/Contusions

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • US Site
  • US Site
  • US Site
  • US Site
  • US Site
  • US Site
  • US Site
  • US Site
  • US Site
  • US Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

diclofenac sodium gel 1%

Placebo

Arm Description

diclofenac sodium gel 1%

Placebo

Outcomes

Primary Outcome Measures

Sum of Pain Intensity Differences Over 24 Hours After Initiating Treatment (SPID 24)
The primary efficacy outcome was the time-weighted SPID 24 (POW). Sum of pain intensity differences over 24 hours after initiating treatment (SPID 24) for the ITT population. SPID 24 derived from spontaneous Pain Intensity scores assessed over 24 hours on a 0 (No pain) - 10 (Pain as bad as you can imagine) Numerical Rating Scale. SPID 24 was computed using the trapezoidal rule, i.e. Σ [T(i) - T(i-1)] x [((PID)(i-1) + PID(i))/2] in an obvious notation, where T(i) is nominal time and PID(i), the pain intensity difference at Time i, is the baseline pain intensity (PI) score - PI score at Time i. Scores were assessed hourly for the first 4 hours and then every 2 hours whilst subjects were awake. Linear interpolation was used to compute an exact SPID as of 24 hours. SPID-24 was computed after all imputation of missing assessments and post-rescue assessments had been completed.

Secondary Outcome Measures

Full Information

First Posted
November 11, 2014
Last Updated
March 8, 2017
Sponsor
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT02290821
Brief Title
Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Compared to Placebo in Subjects With Acute Blunt Trauma Injuries
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (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
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.

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
215 (Actual)

8. Arms, Groups, and Interventions

Arm Title
diclofenac sodium gel 1%
Arm Type
Experimental
Arm Description
diclofenac sodium gel 1%
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Type
Drug
Intervention Name(s)
Placebos
Primary Outcome Measure Information:
Title
Sum of Pain Intensity Differences Over 24 Hours After Initiating Treatment (SPID 24)
Description
The primary efficacy outcome was the time-weighted SPID 24 (POW). Sum of pain intensity differences over 24 hours after initiating treatment (SPID 24) for the ITT population. SPID 24 derived from spontaneous Pain Intensity scores assessed over 24 hours on a 0 (No pain) - 10 (Pain as bad as you can imagine) Numerical Rating Scale. SPID 24 was computed using the trapezoidal rule, i.e. Σ [T(i) - T(i-1)] x [((PID)(i-1) + PID(i))/2] in an obvious notation, where T(i) is nominal time and PID(i), the pain intensity difference at Time i, is the baseline pain intensity (PI) score - PI score at Time i. Scores were assessed hourly for the first 4 hours and then every 2 hours whilst subjects were awake. Linear interpolation was used to compute an exact SPID as of 24 hours. SPID-24 was computed after all imputation of missing assessments and post-rescue assessments had been completed.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
US Site
City
Bradenton
State/Province
Florida
Country
United States
Facility Name
US Site
City
Port Orange
State/Province
Florida
Country
United States
Facility Name
US Site
City
Boise
State/Province
Idaho
Country
United States
Facility Name
US Site
City
Grand Rapids
State/Province
Michigan
Country
United States
Facility Name
US Site
City
Omaha
State/Province
Nebraska
Country
United States
Facility Name
US Site
City
Brooklyn
State/Province
New York
Country
United States
Facility Name
US Site
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
US Site
City
State College
State/Province
Pennsylvania
Country
United States
Facility Name
US Site
City
Bellaine
State/Province
Texas
Country
United States
Facility Name
US Site
City
Houston
State/Province
Texas
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Compared to Placebo in Subjects With Acute Blunt Trauma Injuries

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