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

NCT01272947 | Completed Phase 3 Results

• 1 other identifier: VOSG-P-319
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 6

Brief 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

Acute Blunt Soft Tissue Injuries/Contusions

Keywords

Blunt soft tissue injury/contusion

Outcome Measures

Primary Outcomes (1)

• Pain on Movement

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

  VAS Score at 24 hours

Secondary Outcomes (1)

• Onset of Pain Relief

  From randomization to end of day 1

Study Arms (2)

Diclofenac sodium topical gel 1%

EXPERIMENTAL

Drug: Diclofenac sodium

placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Diclofenac sodium DRUG

Topical gel 1%- 4 times daily

Diclofenac sodium topical gel 1%

Placebo OTHER

Topical gel - 4 times daily

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis: lead

Study Sites (6)

NCH investigative site

Brühl, Germany

Location

NCH investigative site

Butzbach, Germany

Location

NCH investigative site

Cologne, Germany

Location

NCH investigative site

Essen, Germany

Location

NCH investigative site

Gilching, Germany

Location

NCH investigative site

Munich, Germany

Location

MeSH Terms

Conditions

Contusions

Interventions

Diclofenac

Condition Hierarchy (Ancestors)

Wounds, Nonpenetrating; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Results Point of Contact

• Title: Clinical Project Leader
• Organization: Novartis Consumer Health S.A.

+41 22 3635528

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2011
• First Posted: January 10, 2011
• Study Start: January 1, 2011
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: January 10, 2013
• Results First Posted: January 10, 2013

Record last verified: 2012-12

Locations

DE (6)