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

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.

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Key information

Conditions

Acute Blunt Soft Tissue Injuries/Contusions Contusions Wounds and Injuries Wounds, Nonpenetrating

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

US Site, Bradenton, Florida, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

Placebos

Drug

Primary outcomes

Sum of Pain Intensity Differences Over 24 Hours After Initiating Treatment (SPID 24)

Time frame: 24 hours

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.

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Nov 14, 2014
Registry last updated: Apr 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed