Acute PainPhase 3SUPPORT 2NCT00869180
Diclofenac Patch for Treatment of Acute Pain Due to Mild to Moderate Ankle Sprain
A Phase 3 study testing Diclofenac Sodium in people with Acute Pain and Ankle Sprain, run by Cerimon Pharmaceuticals at 1 site in United States.
Trial summary
The primary purpose of this study is to assess the effectiveness of once daily application of a diclofenac sodium topical patch in reducing acute pain due to mild to moderate ankle sprains when applied to the painful area. Read more about this study
- Who is it for?
- Ages 17 to 75 years
- Conditions the study is for
- Acute Pain, Ankle Sprain
- What is being tested?
- Diclofenac Sodium
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 219 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Aug 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 17 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male and female subjects 17 - 75 years of age
- Sustained recent, painful unilateral mild to moderate ankle sprain
- Meet baseline pain criterion
Who cannot join
- Open wound or infection at site of injury
- Evidence of severe injury or ankle fracture
- Use of oral NSAIDs or opioids within 12 - 24 hours of injury
- Presence or history of peptic ulcers or GI bleeding
- A history of intolerance to NSAIDs, acetaminophen, adhesives
- Positive pregnancy test
- Positive drug screen
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of a Diclofenac Sodium Patch for the Topical Treatment of Acute Pain Due to Mild to Moderate Ankle Sprain
The primary purpose of this study is to assess the effectiveness of once daily application of a diclofenac sodium topical patch in reducing acute pain due to mild to moderate ankle sprains when applied to the painful area.
Read the detailed description
This randomized, double-blind, placebo-controlled, parallel group study will be conducted in patients with mild or moderate ankle sprains.
Eligible patients will be randomized (in a 1:1 ratio) to receive double-blind treatment with either the diclofenac topical patch or a matching placebo patch to be applied once daily for 7 days. Patients will return to the clinic for assessments on Day 3 and Day 7; a follow-up assessment will be conducted on Day 14. Patients will complete an electronic diary in which assessments including pain intensity, pain relief and functional disability will be recorded twice daily. Ratings of the quality of sleep will be recorded in the diary each morning, and the use of study treatment and rescue medication will be recorded in the diary each day.
- Conditions
- Acute Pain, Ankle Sprain
- Being tested
- Diclofenac Sodium, Matching Placebo Patch
- Keywords
- diclofenac, ankle sprain, acute pain, topical, patch, Acute Pain due to Mild to Moderate Ankle Sprain
- Medical subject headings
- Acute Pain, Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diclofenac SodiumDrug
Topical diclofenac patch applied once daily to area of pain
Matching Placebo PatchDrug
Matching placebo patch, containing identical constituents to the active comparator except for diclofenac sodium; applied once daily
| Study group | Role | What they receive |
|---|---|---|
| Diclofenac Sodium Patch | Experimental | Not described Receives: Drug: Diclofenac Sodium |
| Topical Placebo Patch | Placebo comparator | Not described Receives: Drug: Matching Placebo Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in average pain during daily activity at Day 3
Measured: Day 3
Secondary outcomes (1)
Change in average pain during daily activity at Day 7
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2009 (estimated)
- Study startFeb 2009
- Primary completionJun 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PainStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cerimon Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00869180
- Sponsor's protocol ID
- DCF-004
- Acronym
- SUPPORT 2
- Status last verified
- Jan 2010
- First submitted
- 24 Mar 2009
- Last updated
- 28 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of a Diclofenac Sodium Patch for the Topical Treatment of Acute Pain Due to Mild to Moderate Ankle Sprain
- ClinicalTrials.gov ID
- NCT00869180
- Acronym / sponsor ID
- SUPPORT 2 / DCF-004
- Conditions
- Acute Pain, Ankle Sprain
- Keywords
- diclofenac, ankle sprain, acute pain, topical, patch, Acute Pain due to Mild to Moderate Ankle Sprain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- Cerimon PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP
- Study start
- Feb 2009
- Primary completion
- Jun 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 25 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to assess the effectiveness of once daily application of a diclofenac sodium topical patch in reducing acute pain due to mild to moderate ankle sprains when applied to the painful area.
Detailed description
This randomized, double-blind, placebo-controlled, parallel group study will be conducted in patients with mild or moderate ankle sprains.
Eligible patients will be randomized (in a 1:1 ratio) to receive double-blind treatment with either the diclofenac topical patch or a matching placebo patch to be applied once daily for 7 days. Patients will return to the clinic for assessments on Day 3 and Day 7; a follow-up assessment will be conducted on Day 14. Patients will complete an electronic diary in which assessments including pain intensity, pain relief and functional disability will be recorded twice daily. Ratings of the quality of sleep will be recorded in the diary each morning, and the use of study treatment and rescue medication will be recorded in the diary each day.
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 Sodium Patch | Experimental | Drug: Diclofenac Sodium |
| Topical Placebo Patch | Placebo comparator | Drug: Matching Placebo Patch |
Who may qualify
- Ages
- 17 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female subjects 17 - 75 years of age
- Sustained recent, painful unilateral mild to moderate ankle sprain
- Meet baseline pain criterion
Key exclusion criteria (7 listed)
- Open wound or infection at site of injury
- Evidence of severe injury or ankle fracture
- Use of oral NSAIDs or opioids within 12 - 24 hours of injury
- Presence or history of peptic ulcers or GI bleeding
- A history of intolerance to NSAIDs, acetaminophen, adhesives
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 SodiumTopical diclofenac patch applied once daily to area of pain | Drug | Diclofenac Sodium Patch |
| Matching Placebo PatchMatching placebo patch, containing identical constituents to the active comparator except for diclofenac sodium; applied once daily | Drug | Topical Placebo Patch |
Primary outcome
Change in average pain during daily activity at Day 3
Time frame: Day 3
1 secondary outcome
Change in average pain during daily activity at Day 7
Time frame: Day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2010.
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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.
1 site 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 Sodium in people with Acute Pain and Ankle Sprain, run by Cerimon Pharmaceuticals at 1 site in United States.
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 7 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 28 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in average pain during daily activity at Day 3 (time frame: Day 3). 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 28 Jan 2010.