Ankle SprainPhase 2/3NCT00640705
Diclofenac Patch for Treatment of Mild to Moderate Ankle Sprain
A Phase 2/3 study testing diclofenac sodium in people with 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 patch to the skin near or over the painful area. In this study, the location being studied will be either the left or right ankle. 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 sodium
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 170 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Oct 2008
- Phase
- Phase 2/3
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 75 years of age
- Has sustained a painful Grade 1 or 2 ankle sprain (Appendix H) no more than 48 hours prior to study entry
- Presence of pain of at least 5, with a maximum of 9, on an 11-point Numerical Rating Scale (NRS)
Who cannot join
- Grade 3 ankle sprain or bilateral sprain (see Appendix H)
- Previous injury to the same ankle within 3 months prior to current injury
- Aspirin or short half-life NSAID use within 12 hours, or longer half-life NSAID use within 24 hours prior to study entry (Appendix B)
- Opioid use within 24 hours prior to study entry
- Topical treatment, other than ice packs, applied to the painful region since time of injury
- A history of peptic ulcer disease within 1 year of study entry, any history of gastrointestinal bleeding or coagulation disorder
Show all 12Show fewer
- A history of, or evidence for, underlying disease in the injured ankle, such as osteoarthritis or gout
- Clinically significant, poorly controlled pulmonary, gastrointestinal, hepatic, renal, endocrine, or cardiovascular disease
- A history of hypersensitivity to diclofenac or diclofenac-containing products
- A history of intolerance to acetaminophen (rescue medication in this trial)
- A history of skin sensitivity to adhesives (e.g. adhesive tape)
- Pregnant or breastfeeding women and women of child-bearing potential not using effective means of contraception
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 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 patch to the skin near or over the painful area. In this study, the location being studied will be either the left or right ankle.
The secondary purpose of this study is to assess the safety and tolerability of a diclofenac patch on the skin.
Read the detailed description
Cerimon Pharmaceuticals is investigating a topical patch formulation of diclofenac sodium containing 15 mg of diclofenac sodium for the local treatment of acute musculoskeletal pain.
- Conditions
- Ankle Sprain
- Being tested
- diclofenac sodium, Matching placebo patch
- 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 sodiumDrug
Also called diclofenac
15 mg (1%) topical patch; measuring 7 cm by 10 cm; applied once daily
Matching placebo patchDrug
Also called placebo comparator
Matching placebo patch, containing identical constituents to the active comparator except for diclofenac sodium; measuring 7 cm by 10 cm; applied once daily
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Topical diclofenac sodium patch Receives: Drug: diclofenac sodium |
| B | Placebo comparator | Topical patch identical in appearance to active comparator, except without diclofenac sodium Receives: Drug: Matching placebo patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the efficacy of diclofenac in subjects with mild to moderate ankle sprain.
Measured: 7 days
Secondary outcomes (1)
Assess the safety and tolerability of diclofenac in subjects with mild to moderate ankle sprain.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2008 (estimated)
- Study startJan 2008
- Primary completionJul 2008
- Study completionOct 2008 (estimated)
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cerimon Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP
- Investigators
- Dan Levitt, MD, Study director, Cerimon Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00640705
- Sponsor's protocol ID
- DCF-002
- Status last verified
- Sep 2008
- First submitted
- 18 Mar 2008
- Last updated
- 4 Sep 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2008. 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 Pain Due to Mild to Moderate Ankle Sprain.
- ClinicalTrials.gov ID
- NCT00640705
- Acronym / sponsor ID
- DCF-002
- Conditions
- Ankle Sprain
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Cerimon PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP
- Study start
- Jan 2008
- Primary completion
- Jul 2008 (actual)
- Study completion
- Oct 2008 (estimated)
- First posted
- 21 Mar 2008 (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 patch to the skin near or over the painful area. In this study, the location being studied will be either the left or right ankle.
The secondary purpose of this study is to assess the safety and tolerability of a diclofenac patch on the skin.
Detailed description
Cerimon Pharmaceuticals is investigating a topical patch formulation of diclofenac sodium containing 15 mg of diclofenac sodium for the local treatment of acute musculoskeletal pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: diclofenac sodiumTopical diclofenac sodium patch |
| B | Placebo comparator | Drug: Matching placebo patchTopical patch identical in appearance to active comparator, except without diclofenac sodium |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 to 75 years of age
- Has sustained a painful Grade 1 or 2 ankle sprain (Appendix H) no more than 48 hours prior to study entry
- Presence of pain of at least 5, with a maximum of 9, on an 11-point Numerical Rating Scale (NRS)
Key exclusion criteria (12 listed)
- Grade 3 ankle sprain or bilateral sprain (see Appendix H)
- Previous injury to the same ankle within 3 months prior to current injury
- Aspirin or short half-life NSAID use within 12 hours, or longer half-life NSAID use within 24 hours prior to study entry (Appendix B)
- Opioid use within 24 hours prior to study entry
- Topical treatment, other than ice packs, applied to the painful region since time of injury
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 sodiumAlso: diclofenac15 mg (1%) topical patch; measuring 7 cm by 10 cm; applied once daily | Drug | A |
| Matching placebo patchAlso: placebo comparatorMatching placebo patch, containing identical constituents to the active comparator except for diclofenac sodium; measuring 7 cm by 10 cm; applied once daily | Drug | B |
Primary outcome
Assess the efficacy of diclofenac in subjects with mild to moderate ankle sprain.
Time frame: 7 days
1 secondary outcome
Assess the safety and tolerability of diclofenac in subjects with mild to moderate ankle sprain.
Time frame: 7 days
Results and safety
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2008.
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.
Dan Levitt, MD study director
Cerimon Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing diclofenac sodium in people with 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 12 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: stopped early, as of the sponsor's last update on 4 Sep 2008. 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 combined 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.
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 was stopped early (reason given: Sponsor decision). Results are not available in the source record.
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?
Assess the efficacy of diclofenac in subjects with mild to moderate ankle sprain. (time frame: 7 days). 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 4 Sep 2008.