Skip to main content
OpenTrials
Completed

NCT Number: NCT01272947

Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Applied Four Times Daily in Subjects With Acute Blunt Trauma Injuries

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

NCH investigative site, Brühl, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Diclofenac Sodium

Drug

Topical gel 1%- 4 times daily

Placebo

Other

Topical gel - 4 times daily

Primary outcomes

  1. Pain on Movement

    Time frame: VAS Score at 24 hours

    Visual analog scale (VAS) assessed on a 100 mm scale with anchors at 0= "No pain" and 100= "Extreme pain"

Secondary outcomes

  1. Onset of Pain Relief

    Time frame: From randomization to end of day 1

    Onset of perceptible pain relief.

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jan 10, 2011
Registry last updated
Jan 10, 2013

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.

Related clinical trials

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