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Efficacy and Safety of Diclofenac Diethylamine 2.32% Gel in Patients With Acute Ankle Sprain

Primary Purpose

Ankle Sprain

Status

Completed

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

Diclofenac diethylamine 2.32% gel

Placebo

Diclofenac diethylamine 2.32% gel / Placebo

About this trial

This is an interventional treatment trial for Ankle Sprain focused on measuring Ankle, sprain, diclofenac diethylamine

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Acute sprain of the ankle
Injury within past 48 hours.

Exclusion Criteria:

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

Other protocol-defined inclusion/exclusion criteria may apply

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

NCT ID

NCT00573768

First Posted

December 13, 2007

Last Updated

April 18, 2012

Sponsor

Novartis

1. Study Identification

Unique Protocol Identification Number

NCT00573768

Brief Title

Efficacy and Safety of Diclofenac Diethylamine 2.32% Gel in Patients With Acute Ankle Sprain

Official Title

A Randomized, Double-blind, Multi-center, Vehicle-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Diclofenac Diethylamine 2.32% Gel Applied Once or Twice Daily in Patients With Acute Ankle Sprain

Study Type

Interventional

2. Study Status

Record Verification Date

October 2010

Overall Recruitment Status

Completed

Study Start Date

November 2007 (undefined)

Primary Completion Date

December 2007 (Actual)

Study Completion Date

July 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ankle Sprain

Keywords

Ankle, sprain, diclofenac diethylamine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

271 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Title

Arm Type

Placebo Comparator

Arm Title

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Diclofenac diethylamine 2.32% gel

Intervention Description

Diclofenac diethylamine 2.32% gel twice daily

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Vehicle 2 times daily

Intervention Type

Drug

Intervention Name(s)

Diclofenac diethylamine 2.32% gel / Placebo

Intervention Description

Diclofenac diethylamine 2.32% gel once daily / Vehicle once daily

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

change from baseline (on day 1) to day 5

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Acute sprain of the ankle Injury within past 48 hours. Exclusion Criteria: 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 Other protocol-defined inclusion/exclusion criteria may apply

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Axel Baltzer

Official's Role

Principal Investigator

Facility Information:

Facility Name

Novartis Investigative Site

City

Bad Bramstedt

ZIP/Postal Code

24576

Country

Germany

Facility Name

Novartis Investigative Site

City

Bad Nauheim

ZIP/Postal Code

61231

Country

Germany

Facility Name

Novartis Investigative Site

City

Bad Zwischenahn

ZIP/Postal Code

26160

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

10589

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

10961

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

12247

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

12349

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

14163

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

14169

Country

Germany

Facility Name

Novartis Investigative Site

City

Bochum

ZIP/Postal Code

44789

Country

Germany

Facility Name

Novartis Investigative Site

City

Dortmund

ZIP/Postal Code

44263

Country

Germany

Facility Name

Novartis Investigative Site

City

Dresden

ZIP/Postal Code

01129

Country

Germany

Facility Name

Novartis Investigative Site

City

Dusseldorf

ZIP/Postal Code

40212

Country

Germany

Facility Name

Novartis Investigative Site

City

Eichstätt

ZIP/Postal Code

85072

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

20357

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

22143

Country

Germany

Facility Name

Novartis Investigative Site

City

Hammelburg

ZIP/Postal Code

97762

Country

Germany

Facility Name

Novartis Investigative Site

City

Karlsruhe

ZIP/Postal Code

76133

Country

Germany

Facility Name

Novartis Investigative Site

City

Kaufbeuren

ZIP/Postal Code

87600

Country

Germany

Facility Name

Novartis Investigative Site

City

Lambrecht/Pfalz

ZIP/Postal Code

67466

Country

Germany

Facility Name

Novartis Investigative Site

City

Leipzig

ZIP/Postal Code

04109

Country

Germany

Facility Name

Novartis Investigative Site

City

Meersburg

ZIP/Postal Code

88709

Country

Germany

Facility Name

Novartis Investigative Site

City

Munchen

ZIP/Postal Code

80333

Country

Germany

Facility Name

Novartis Investigative Site

City

Munchen

ZIP/Postal Code

80538

Country

Germany

Facility Name

Novartis Investigative Site

City

Munchen

ZIP/Postal Code

80798

Country

Germany

Facility Name

Novartis Investigative Site

City

Munich

ZIP/Postal Code

80339

Country

Germany

Facility Name

Novartis Investigative Site

City

Neustadt/Aisch

ZIP/Postal Code

91413

Country

Germany

Facility Name

Novartis Investigative Site

City

Siegen

ZIP/Postal Code

57074

Country

Germany

Facility Name

Novartis Investigative Site

City

Stockach

ZIP/Postal Code

78333

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

Efficacy and Safety of Diclofenac Diethylamine 2.32% Gel in Patients With Acute Ankle Sprain

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Efficacy and Safety of Diclofenac Diethylamine 2.32% Gel in Patients With Acute Ankle Sprain

Ankle Sprain

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial