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

Phase 3

Completed

• Conditions: Acute Blunt Soft Tissue Injuries/Contusions
• Interventions: Drug: Placebos; Drug: placebo

• Registration Number: NCT02290821
• Lead Sponsor: Novartis

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-11-11
• Study First Submitted QC: 2014-11-13
• Study First Posted: 2014-11-14
• Study Start: 2014-12
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Results First Submitted: 2016-09-20
• Status Verified: 2017-03
• Results First Submitted QC: 2017-03-08
• Last Update Submitted: 2017-03-08
• Results First Posted: 2017-04-19
• Last Update Posted: 2017-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 215

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebos	Placebo
diclofenac sodium gel 1%	placebo	diclofenac sodium gel 1%

Primary Outcome Measures

Name	Time	Method
Sum of Pain Intensity Differences Over 24 Hours After Initiating Treatment (SPID 24)	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.

Trial Locations

Locations (1)

US Site; 🇺🇸 Houston, Texas, United States