NCT00573768

Brief Summary

This study will evaluate the efficacy of diclofenac diethylamine 2.32% gel in the treatment of acute ankle sprain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
271

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

29 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

December 13, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 14, 2007

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

November 18, 2010

Completed
Last Updated

April 20, 2012

Status Verified

October 1, 2010

Enrollment Period

1 month

First QC Date

December 13, 2007

Results QC Date

July 28, 2010

Last Update Submit

April 18, 2012

Conditions

Ankle Sprain

Keywords

Ankle, sprain, diclofenac diethylamine

Outcome Measures

Primary Outcomes (1)

  • Pain on Movement on Day 5 (Change From Baseline). A Greater Change From Baseline on Day 5 Equates to a Better Outcome.

    Pain on movement: visual analogue scale (VAS) with anchors at 0 mm (no pain) and 100 mm (extreme pain)

    change from baseline (on day 1) to day 5

Study Arms (3)

1

ACTIVE COMPARATOR
Drug: Diclofenac diethylamine 2.32% gel

2

PLACEBO COMPARATOR
Drug: Placebo

3

ACTIVE COMPARATOR
Drug: Diclofenac diethylamine 2.32% gel / Placebo

Interventions

Diclofenac diethylamine 2.32% gelDRUG

Diclofenac diethylamine 2.32% gel twice daily

1
PlaceboDRUG

Vehicle 2 times daily

2
Diclofenac diethylamine 2.32% gel / PlaceboDRUG

Diclofenac diethylamine 2.32% gel once daily / Vehicle once daily

3

Eligibility Criteria

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

You may qualify if:

  • Acute sprain of the ankle
  • Injury within past 48 hours.

You may not qualify if:

  • Pain medication taken since the injury
  • Pain or instability in the same ankle due to previous ankle sprain or any other trauma.
  • Ankle sprain due to a known disease affecting the ligaments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (29)

Novartis Investigative Site

Bad Bramstedt, 24576, Germany

Location

Novartis Investigative Site

Bad Nauheim, 61231, Germany

Location

Novartis Investigative Site

Bad Zwischenahn, 26160, Germany

Location

Novartis Investigative Site

Berlin, 10589, Germany

Location

Novartis Investigative Site

Berlin, 10961, Germany

Location

Novartis Investigative Site

Berlin, 12247, Germany

Location

Novartis Investigative Site

Berlin, 12349, Germany

Location

Novartis Investigative Site

Berlin, 14163, Germany

Location

Novartis Investigative Site

Berlin, 14169, Germany

Location

Novartis Investigative Site

Bochum, 44789, Germany

Location

Novartis Investigative Site

Dortmund, 44263, Germany

Location

Novartis Investigative Site

Dresden, 01129, Germany

Location

Novartis Investigative Site

Düsseldorf, 40212, Germany

Location

Novartis Investigative Site

Eichstätt, 85072, Germany

Location

Novartis Investigative Site

Hamburg, 20357, Germany

Location

Novartis Investigative Site

Hamburg, 22143, Germany

Location

Novartis Investigative Site

Hammelburg, 97762, Germany

Location

Novartis Investigative Site

Karlsruhe, 76133, Germany

Location

Novartis Investigative Site

Kaufbeuren, 87600, Germany

Location

Novartis Investigative Site

Lambrecht/Pfalz, 67466, Germany

Location

Novartis Investigative Site

Leipzig, 04109, Germany

Location

Novartis Investigative Site

Meersburg, 88709, Germany

Location

Novartis Investigative Site

Munich, 80339, Germany

Location

Novartis Investigative Site

München, 80333, Germany

Location

Novartis Investigative Site

München, 80538, Germany

Location

Novartis Investigative Site

München, 80798, Germany

Location

Novartis Investigative Site

Neustadt/Aisch, 91413, Germany

Location

Novartis Investigative Site

Siegen, 57074, Germany

Location

Novartis Investigative Site

Stockach, 78333, Germany

Location

MeSH Terms

Conditions

Ankle InjuriesSprains and Strains

Interventions

diclofenac diethylamineGels

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

ColloidsComplex MixturesDosage FormsPharmaceutical Preparations

Results Point of Contact

Title
Sandy Hamelsky
Organization
Novartis Consumer Health
sandy.hamelsky@novartis.com
+19735037258

Study Officials

  • Axel Baltzer

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2007

First Posted

December 14, 2007

Study Start

November 1, 2007

Primary Completion

December 1, 2007

Study Completion

July 1, 2008

Last Updated

April 20, 2012

Results First Posted

November 18, 2010

Record last verified: 2010-10

Locations

DE(29)