NCT00931866

Brief Summary

The primary purpose of this study is to assess the effectiveness of once daily application of a diclofenac sodium topical patch in reducing mild to moderate soft tissue injuries when applied to the painful area.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
407

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Apr 2009

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 29, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 2, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

August 16, 2010

Status Verified

August 1, 2010

Enrollment Period

5 months

First QC Date

June 29, 2009

Last Update Submit

August 12, 2010

Conditions

Acute PainSoft Tissue Injury

Keywords

diclofenacacute paintopicalpatchAcute Pain due to Mild to Moderate Soft Tissue Injury

Outcome Measures

Primary Outcomes (1)

  • Change in average pain during daily activity at Day 7

    Day 7

Secondary Outcomes (1)

  • Change in average pain during daily activity at Day 14

    Day 14

Study Arms (2)

Diclofenac Sodium Patch

EXPERIMENTAL
Drug: Diclofenac Sodium

Topical Placebo Patch

PLACEBO COMPARATOR
Drug: Matching Placebo Patch

Interventions

Diclofenac SodiumDRUG

Topical diclofenac patch applied once daily to area of pain

Diclofenac Sodium Patch
Matching Placebo PatchDRUG

Matching placebo patch, containing identical constituents to the active comparator except for diclofenac sodium; applied once daily

Topical Placebo Patch

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female subjects 18-75 years of age
  • Sustained recent, painful unilateral mild to moderate soft tissue injury (between the mid-bicep to wrist or mid-thigh to ankle)
  • Meet baseline pain criterion

You may not qualify if:

  • Open wound or infection at site of injury
  • Evidence of severe injury, including fracture or nerve injury
  • Use of oral NSAIDs or opioids within 12-24 hours of injury
  • Presence or history of peptic ulcers or GI bleeding
  • A history of intolerance to NSAIDs, acetaminophen, adhesives
  • Positive pregnancy test
  • Positive drug screen

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PPD

Austin, Texas, United States

Location

MeSH Terms

Conditions

Acute PainSoft Tissue Injuries

Interventions

Diclofenac

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsWounds and Injuries

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

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

Study Record Dates

First Submitted

June 29, 2009

First Posted

July 2, 2009

Study Start

April 1, 2009

Primary Completion

September 1, 2009

Study Completion

December 1, 2009

Last Updated

August 16, 2010

Record last verified: 2010-08

Locations

US(1)