Grade I/II Ankle SprainPhase 3NCT00955513
Evaluate the Efficacy and Safety of Diclofenac Diethylamine 2.32% Gel Applied Twice or Three Times Daily in Patients With Acute Ankle Sprain
A Phase 3 study testing diclofenac diethylamine gel 2.32% in people with Grade I/II Ankle Sprain, run by Novartis at 5 sites in Germany.
Trial summary
The main purpose of this trial is to compare the efficacy and safety of diclofenac diethylamine 2.32% gel applied twice (b.i.d) or three times a day (t.i.d.) with placebo in the treatment of acute ankle sprains (distortions). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Grade I/II Ankle Sprain
- What is being tested?
- diclofenac diethylamine gel 2.32%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 242 participants
- Where
- 5 sitesGermany
- Study dates
- Jul 2009to Dec 2009
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Acute sprain of the lateral ankle, Grade I-II .
Who cannot join
- Any concurrent injury affecting the lower extremities that is painful at rest or on movement, or could affect the mobilization of the patient.
- Topical analgesic or anti-inflammatory treatment over the previous month in the area to be treated.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Germany5 sites
Novartis Investigative Site
Cologne
Novartis Investigative Site
Essen
Novartis Investigative Site
Gilching
Novartis Investigative Site
Grünwald
Novartis Investigative Site
München
About this study
Official title: A Randomized, Double-blind, Multi-center, Placebo-controlled, 3-treatment Arm, Parallel Group Study to Evaluate the Efficacy and Safety of Diclofenac Diethylamine 2.32% Gel Applied Twice or Three Times Daily in Patients With Acute Ankle Sprain
The main purpose of this trial is to compare the efficacy and safety of diclofenac diethylamine 2.32% gel applied twice (b.i.d) or three times a day (t.i.d.) with placebo in the treatment of acute ankle sprains (distortions).
- Conditions
- Grade I/II Ankle Sprain
- Being tested
- diclofenac diethylamine gel 2.32%, Placebo
- Keywords
- Ankle sprain, soft tissue injury
- Medical subject headings
- Ankle Injuries, Soft Tissue Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diclofenac diethylamine gel 2.32%Drug
diclofenac diethylamine gel 2.32% twice a day
diclofenac diethylamine gel 2.32%Drug
diclofenac diethylamine gel 2.32% three times a day
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| diclofenac diethylamine gel 2.32% gel twice a day | Experimental | drug Receives: Drug: diclofenac diethylamine gel 2.32% |
| diclofenac diethylamine gel 2.32% gel three times a day | Experimental | drug Receives: Drug: diclofenac diethylamine gel 2.32% |
| placebo | Placebo comparator | placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure: Pain on Movement on Day 5 (Change From Baseline).
Visual analog scale (0 to 100 mm) A greater change from baseline equates to a better outcome.
Measured: baseline and day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2009 (estimated)
- Study startJul 2009
- Primary completionDec 2009
- Study completionDec 2009
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 Grade I/II 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00955513
- Sponsor's protocol ID
- VOPO-P-307
- Status last verified
- Jan 2011
- First submitted
- 7 Aug 2009
- Last updated
- 20 Apr 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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, Placebo-controlled, 3-treatment Arm, Parallel Group Study to Evaluate the Efficacy and Safety of Diclofenac Diethylamine 2.32% Gel Applied Twice or Three Times Daily in Patients With Acute Ankle Sprain
- ClinicalTrials.gov ID
- NCT00955513
- Acronym / sponsor ID
- VOPO-P-307
- Conditions
- Grade I/II Ankle Sprain
- Keywords
- Ankle sprain, soft tissue injury
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 10 Aug 2009 (estimated)
- Results
- Posted 26 Jan 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this trial is to compare the efficacy and safety of diclofenac diethylamine 2.32% gel applied twice (b.i.d) or three times a day (t.i.d.) with placebo in the treatment of acute ankle sprains (distortions).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| diclofenac diethylamine gel 2.32% gel twice a day | Experimental | Drug: diclofenac diethylamine gel 2.32%drug |
| diclofenac diethylamine gel 2.32% gel three times a day | Experimental | Drug: diclofenac diethylamine gel 2.32%drug |
| placebo | Placebo comparator | Drug: Placeboplacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Acute sprain of the lateral ankle, Grade I-II .
Key exclusion criteria (2 listed)
- Any concurrent injury affecting the lower extremities that is painful at rest or on movement, or could affect the mobilization of the patient.
- Topical analgesic or anti-inflammatory treatment over the previous month in the area to be treated.
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 gel 2.32%diclofenac diethylamine gel 2.32% twice a day | Drug | diclofenac diethylamine gel 2.32% gel twice a day |
| diclofenac diethylamine gel 2.32%diclofenac diethylamine gel 2.32% three times a day | Drug | diclofenac diethylamine gel 2.32% gel three times a day |
| PlaceboPlacebo | Drug | placebo |
Primary outcome
Measure: Pain on Movement on Day 5 (Change From Baseline).
Time frame: baseline and day 5
Visual analog scale (0 to 100 mm) A greater change from baseline equates to a better outcome.
Results and safety
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.
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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing diclofenac diethylamine gel 2.32% in people with Grade I/II Ankle Sprain, run by Novartis at 5 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 1 inclusion and 2 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 5 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 26 Jan 2011). 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?
Measure: Pain on Movement on Day 5 (Change From Baseline). (time frame: baseline and day 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.