Ankle SprainPhase 2NCT00573768

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

A Phase 2 study testing Diclofenac diethylamine 2.32% gel in people with Ankle Sprain, run by Novartis at 29 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Ankle Sprain
What is being tested?: Diclofenac diethylamine 2.32% gel
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 271 participants
Where: 29 sitesGermany
Study dates: Nov 2007to Jul 2008
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Acute sprain of the ankle
Injury within past 48 hours.

Who cannot join

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

Trial locations and contacts

29 sites in 1 country.

City, postcode or hospital

29 sites in 1 country

Germany29 sites

Novartis Investigative Site
Bad Bramstedt, 24576
Novartis Investigative Site
Bad Nauheim, 61231
Novartis Investigative Site
Bad Zwischenahn, 26160
Novartis Investigative Site
Berlin, 10589
Novartis Investigative Site
Berlin, 10961
Novartis Investigative Site
Berlin, 12247
Novartis Investigative Site
Berlin, 12349
Novartis Investigative Site
Berlin, 14163
Novartis Investigative Site
Berlin, 14169
Novartis Investigative Site
Bochum, 44789
Novartis Investigative Site
Dortmund, 44263
Novartis Investigative Site
Dresden, 01129
Novartis Investigative Site
Düsseldorf, 40212
Novartis Investigative Site
Eichstätt, 85072
Novartis Investigative Site
Hamburg, 20357
Novartis Investigative Site
Hamburg, 22143
Novartis Investigative Site
Hammelburg, 97762
Novartis Investigative Site
Karlsruhe, 76133
Novartis Investigative Site
Kaufbeuren, 87600
Novartis Investigative Site
Lambrecht/Pfalz, 67466
Novartis Investigative Site
Leipzig, 04109
Novartis Investigative Site
Meersburg, 88709
Novartis Investigative Site
München, 80333
Novartis Investigative Site
München, 80538
Novartis Investigative Site
München, 80798
Novartis Investigative Site
Munich, 80339
Novartis Investigative Site
Neustadt/Aisch, 91413
Novartis Investigative Site
Siegen, 57074
Novartis Investigative Site
Stockach, 78333

Other trials in Germany

About this study

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

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

Conditions: Ankle Sprain
Being tested: Diclofenac diethylamine 2.32% gel, Placebo, Diclofenac diethylamine 2.32% gel / Placebo
Keywords: Ankle, sprain, diclofenac diethylamine
Medical subject headings: Ankle Injuries, Sprains and Strains

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Diclofenac diethylamine 2.32% gelDrug
Diclofenac diethylamine 2.32% gel twice daily
PlaceboDrug
Vehicle 2 times daily
Diclofenac diethylamine 2.32% gel / PlaceboDrug
Diclofenac diethylamine 2.32% gel once daily / Vehicle once daily

Study groups in NCT00573768
Study group	Role	What they receive
1	Active comparator	Not described Receives: Drug: Diclofenac diethylamine 2.32% gel
2	Placebo comparator	Not described Receives: Drug: Placebo
3	Active comparator	Not described Receives: Drug: Diclofenac diethylamine 2.32% gel / Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: change from baseline (on day 1) to day 5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2007Jul 2008

First posted14 Dec 2007 (estimated)
Study startNov 2007
Primary completionDec 2007
Study completionJul 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Ankle SprainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 271 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00573768
Sponsor's protocol ID: VOPO-PE-201
Status last verified: Oct 2010
First submitted: 13 Dec 2007
Last updated: 20 Apr 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Functional Recovery After a Recent Lateral Ankle Sprain With Early Initiation of Rehabilitation: Changes in the Ankle-GO Score and Its Association With Return to Sport and Recurrent Sprains.
Ankle Sprain
Recruiting
Enovis High Ankle Sprain Brace Testing
Athletes in Cutting Sports
Recruiting
The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Amateur Athletes With Chronic Ankle Instability
Ankle Sprain, Ankle Sprain Strain
Recruiting
The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Chronic Ankle Instability
Ankle Sprains, Ankle Sprain Strain
Not yet recruiting
Collagen Scaffold Bioaugmentation for ATFL Repair in Chronic Ankle Instability
Chronic Ankle Instability, Ankle Sprain

All Ankle Sprain trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00573768
Acronym / sponsor ID: VOPO-PE-201
Conditions: Ankle Sprain
Keywords: Ankle, sprain, diclofenac diethylamine
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 271 participants (actual)
Lead sponsor: NovartisIndustry (pharma, biotech, devices)
Study start: Nov 2007
Primary completion: Dec 2007 (actual)
Study completion: Jul 2008 (actual)
First posted: 14 Dec 2007 (estimated)
Results: Posted 18 Nov 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
1	Active comparator	Drug: Diclofenac diethylamine 2.32% gel
2	Placebo comparator	Drug: Placebo
3	Active comparator	Drug: Diclofenac diethylamine 2.32% gel / Placebo

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Acute sprain of the ankle
Injury within past 48 hours.

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Diclofenac diethylamine 2.32% gelDiclofenac diethylamine 2.32% gel twice daily	Drug	1
PlaceboVehicle 2 times daily	Drug	2
Diclofenac diethylamine 2.32% gel / PlaceboDiclofenac diethylamine 2.32% gel once daily / Vehicle once daily	Drug	3

Primary outcome

Pain on Movement on Day 5 (Change From Baseline). A Greater Change From Baseline on Day 5 Equates to a Better Outcome.
Time frame: change from baseline (on day 1) to day 5
Pain on movement: visual analogue scale (VAS) with anchors at 0 mm (no pain) and 100 mm (extreme pain)

Results and safety

Results posted to the registry on 18 Nov 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Diclofenac Diethylamine (DDEA) 2.32% Gel BID	89	87
DDEA 2.32% Gel OD	91	89
Vehicle Gel	91	87

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

Time frame: change from baseline (on day 1) to day 5. Mean (Standard Deviation). Unit: mm

Measure	Diclofenac Diethylamine (DDEA) 2.32% Gel BID n = 89	DDEA 2.32% Gel OD n = 91	Vehicle Gel n = 91
Value	38.3 (22.7)	35.7 (20.4)	33.4 (20.9)

Population analysed: Intent to treat (ITT)

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Diclofenac Diethylamine (DDEA) 2.32% Gel BID	0 of 89 (0%)	3 of 89 (3.4%)	Not reported
DDEA 2.32% Gel OD	0 of 91 (0%)	6 of 91 (6.6%)	Not reported
Vehicle Gel	0 of 91 (0%)	1 of 91 (1.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Ankle Sprain

Not yet recruiting
Functional Recovery After a Recent Lateral Ankle Sprain With Early Initiation of Rehabilitation: Changes in the Ankle-GO Score and Its Association With Return to Sport and Recurrent Sprains.
Ankle Sprain
Recruiting
Enovis High Ankle Sprain Brace Testing
Athletes in Cutting Sports
Recruiting
The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Amateur Athletes With Chronic Ankle Instability
Ankle Sprain, Ankle Sprain Strain
Recruiting
The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Chronic Ankle Instability
Ankle Sprains, Ankle Sprain Strain
Not yet recruiting
Collagen Scaffold Bioaugmentation for ATFL Repair in Chronic Ankle Instability
Chronic Ankle Instability, Ankle Sprain

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Axel Baltzer principal investigator

29 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Diclofenac diethylamine 2.32% gel in people with Ankle Sprain, run by Novartis at 29 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Nov 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain on Movement on Day 5 (Change From Baseline). A Greater Change From Baseline on Day 5 Equates to a Better Outcome. (time frame: change from baseline (on day 1) to day 5). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00573768.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2012.