Ankle SprainPhase 4NCT01666197
Efficacy and Safety of Diclofenac Potassium 25 mg Tablet Taken Three Times Daily in Subjects With Acute Joint Pain
A Phase 4 study testing diclofenac potassium 25 mg tablet in people with Ankle Sprain, run by Novartis at 4 sites in Germany.
Trial summary
The purpose of this study is to evaluate the efficacy of diclofenac potassium 25 mg tablet compared with placebo taken three times a day in subjects with acute ankle sprains under 'in-use' conditions, in particular with regard to pain relief. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankle Sprain
- What is being tested?
- diclofenac potassium 25 mg tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 4 sitesGermany
- Study dates
- Aug 2012to Jan 2013
- Phase
- Phase 4
- 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
- Male or female aged 18 years and over.
- Acute sprain of the lateral ankle, Grade I-II, meeting baseline pain intensity level.
- Injury within past 12 hours.
Who cannot join
- Pain medication was taken within the 6 hours that precede randomization.
- During the past 3 months: Grade I-III sprain of the same ankle.
- During the past 6 months: Grade II-III sprain, any other significant injury (such as fracture or torn ligament), or surgery (except for skin or nails) of the same ankle or foot.
- Pain or instability in the same ankle attributable to previous ankle sprain or any other trauma.
- Ankle sprain attributable to a known disease affecting the ligaments, such as ligament hyperlaxity due to connective tissue disease (e.g., Marfan's syndrome, Down's syndrome, Ehlers-Danlos syndrome).
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
Investigator
Brühl
Investigator
Cologne
Investigator
Essen
Investigator
Gilching
About this study
Official title: A Randomized, Double-blind, Multi-center, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Diclofenac Potassium 25 mg Tablet Taken Three Times Daily in Subjects With Acute Joint Pain
The purpose of this study is to evaluate the efficacy of diclofenac potassium 25 mg tablet compared with placebo taken three times a day in subjects with acute ankle sprains under 'in-use' conditions, in particular with regard to pain relief.
- Conditions
- Ankle Sprain
- Being tested
- diclofenac potassium 25 mg tablet, placebo
- Keywords
- Acute Joint Pain
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diclofenac potassium 25 mg tabletDrug
diclofenac potassium 25 mg tablet
placeboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| diclofenac potassium 25 mg tablet | Experimental | Not described Receives: Drug: diclofenac potassium 25 mg tablet |
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain on Movement
Change on a Visual analog scale from Baseline. Pain on Movement at 48 hours assessed on a 100 mm visual analog scale with anchors at 0="No pain" and 100= "Extreme pain"
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionJan 2013
- Study completionJan 2013
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01666197
- Sponsor's protocol ID
- 853-P-401
- Status last verified
- Mar 2014
- First submitted
- 14 Aug 2012
- Last updated
- 17 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Multi-center, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Diclofenac Potassium 25 mg Tablet Taken Three Times Daily in Subjects With Acute Joint Pain
- ClinicalTrials.gov ID
- NCT01666197
- Acronym / sponsor ID
- 853-P-401
- Conditions
- Ankle Sprain
- Keywords
- Acute Joint Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 16 Aug 2012 (estimated)
- Results
- Posted 27 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy of diclofenac potassium 25 mg tablet compared with placebo taken three times a day in subjects with acute ankle sprains under 'in-use' conditions, in particular with regard to pain relief.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| diclofenac potassium 25 mg tablet | Experimental | Drug: diclofenac potassium 25 mg tablet |
| placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female aged 18 years and over.
- Acute sprain of the lateral ankle, Grade I-II, meeting baseline pain intensity level.
- Injury within past 12 hours.
Key exclusion criteria (5 listed)
- Pain medication was taken within the 6 hours that precede randomization.
- During the past 3 months: Grade I-III sprain of the same ankle.
- During the past 6 months: Grade II-III sprain, any other significant injury (such as fracture or torn ligament), or surgery (except for skin or nails) of the same ankle or foot.
- Pain or instability in the same ankle attributable to previous ankle sprain or any other trauma.
- Ankle sprain attributable to a known disease affecting the ligaments, such as ligament hyperlaxity due to connective tissue disease (e.g., Marfan's syndrome, Down's syndrome, Ehlers-Danlos syndrome).
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 potassium 25 mg tabletdiclofenac potassium 25 mg tablet | Drug | diclofenac potassium 25 mg tablet |
| placeboplacebo | Drug | placebo |
Primary outcome
Pain on Movement
Time frame: 48 hours
Change on a Visual analog scale from Baseline. Pain on Movement at 48 hours assessed on a 100 mm visual analog scale with anchors at 0="No pain" and 100= "Extreme pain"
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing diclofenac potassium 25 mg tablet in people with Ankle Sprain, run by Novartis at 4 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 3 inclusion and 5 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 17 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 27 Mar 2014). 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 (time frame: 48 hours). 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 17 Apr 2014.