CompletedNCT01272947Updated Jan 10, 2013Results posted

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

A Phase 3 interventional study of Diclofenac sodium and Placebo in Acute Blunt Soft Tissue Injuries/Contusions, sponsored by Novartis. Completed at 6 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-01-10.

Sponsored by Novartis · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 204
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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

Conditions studied

Acute Blunt Soft Tissue Injuries/Contusions

Browse trials for

Contusions 43

Keywords

Blunt soft tissue injury/contusion

In context

Contusions

43 studies on the registry are indexed under Contusions; 8 are open to participants now.

This study's enrollment of 204 is above the median of 90 across 31 interventional studies indexed under Contusions.

Browse Contusions studies →

Lead sponsor

Novartis is the lead sponsor of 714 studies on the registry; none are open to participants now.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 204 participants (actual)

Study arms

Experimental
Diclofenac sodium topical gel 1%
Drug: Diclofenac sodium
Placebo comparator
placebo
Other: Placebo

Interventions

DrugDiclofenac sodium
Topical gel 1%- 4 times daily
OtherPlacebo
Topical gel - 4 times daily

What researchers measure

Primary outcomes

Pain on Movement
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 outcomes

Onset of Pain Relief
Onset of perceptible pain relief.
Time frame: From randomization to end of day 1

Results

Posted Jan 10, 2013

Participant flow

Participant flow — Overall Study
Milestone	Diclofenac Sodium Topical Gel 1%	Placebo
Started	104	100
Completed	102	98
Not completed	2	2
Withdrew: Abnormal laboratory value	2	2

Outcome measures

PrimaryPain on Movement

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
Reported as:: Mean · mm

Pain on Movement
mm	Diclofenac Sodium Topical Gel 1%	Placebo
Pain on Movement	33.1 ± 21.4	65.4 ± 16.9

SecondaryOnset of Pain Relief

Onset of perceptible pain relief.

Time frame:: From randomization to end of day 1
Reported as:: Median · Hours

Onset of Pain Relief
Hours	Diclofenac Sodium Topical Gel 1%	Placebo
Onset of Pain Relief	2 (1 to 4)	NA (4.9 to NA)

Adverse events

Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Diclofenac Sodium Topical Gel 1%	—	0/104 (0%)	2/104 (1.9%)
Placebo	—	0/100 (0%)	4/100 (4%)

Most frequent other events

Most frequent other events
Event	Diclofenac Sodium Topical Gel 1%	Placebo
Infections and InfestationsInfections and infestations	2/104	3/100
Musculoskeletal and connective tissue disordersMusculoskeletal and connective tissue disorders	0/104	1/100

Baseline characteristics

Age Continuous
Age Continuous(years)	Diclofenac Sodium Topical Gel 1%	Placebo	Total
Unit : years	29.4 ± 9.6	31.4 ± 12.1	30.4 ± 10.9

Sex: Female, Male
Sex: Female, Male(Participants)	Diclofenac Sodium Topical Gel 1%	Placebo	Total
Female	55	48	103
Male	49	52	101

Region of Enrollment
Region of Enrollment(participants)	Diclofenac Sodium Topical Gel 1%	Placebo	Total
Germany	104	100	204

Study locations

6 sites

NCH investigative site
Brühl, Germany
NCH investigative site
Butzbach, Germany
NCH investigative site
Cologne, Germany
NCH investigative site
Essen, Germany
NCH investigative site
Gilching, Germany
NCH investigative site
Munich, Germany

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2011, a primary completion of Jul 2011 and a completion of Jul 2011. It does not say whether these dates are actual or estimated.

Results were first posted in Jan 2013, 1 year 6 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered: Jan 7, 2011
First posted: Jan 10, 2011
Start: Jan 2011
Primary completionActual: Jul 2011
CompletionActual: Jul 2011
Results first posted: Jan 10, 2013
Last update: Jan 10, 2013

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Jan 10, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01272947
Lead sponsor: Novartis
Responsible party: Sponsor
First posted: Jan 10, 2011
Start date: Jan 2011
Primary completion: Jul 2011
Completion: Jul 2011
Results posted: Jan 10, 2013
Last update: Jan 10, 2013

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.

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Discussion

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