AzTrials
AzTrials

Acute Ankle SprainPhase 3NCT01874626

Efficacy and Safety of SST 0225, a Topical Ibuprofen Cream, in the Treatment of Pain Associated With Acute Ankle Sprain

A Phase 3 study testing SST-0225 Topical Ibuprofen Cream in people with Acute Ankle Sprain, run by Strategic Science & Technologies, LLC at 1 site in United States.

Completed

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

Official record
Search all trials

Trial summary

This is a randomized, multi-center, double-blind, placebo-controlled, multi-dose, parallel-group study. Approximately 300 subjects (150 per group) 16 years of age and older with a current (within 24 hours from Visit 1) Grade I or II ankle sprain, and who meet all eligibility criteria, will be randomized into the study… Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Acute Ankle Sprain
What is being tested?
SST-0225 Topical Ibuprofen Cream
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
305 participants
Where
1 siteUnited States
Study dates
Jun 2013to Jan 2014
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 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Male and female subjects ≥16 years of age
  • Grade I or II acute ankle sprain injury within 24 hours prior to first use of investigational product.
  • Grade I: when the ligament is stretched but not torn and the anterior talofibular ligament is usually involved. The anterior drawer test is negative
  • Grade II: moderate sprain, which usually results in partial tears of the ligaments, primarily the anterior talofibular and possibly the calcaneofibular ligament. Ligamentous laxity may be present and there is moderate swelling
  • At screening (Visit 1), subject reported pain intensity score upon movement of ≥ 5 on a 0-10 Numerical Rating Scale (NRS)
  • Subject's Assessment of Normal Function/Activity (must be > 2) at screening
Show all 14Show fewer
  • Able to comply with the visit schedule
  • Able to apply the investigational product as directed
  • Females of childbearing potential must be willing to use an approved method of birth control during study participation. Subjects currently using any of the below mentioned contraception methods, must have used the method for a minimum of three months prior to study enrollment, and must be willing to continue its use (at the same dose) throughout the study.
  • Effective methods of birth control: e.g. prescription oral, vaginal or transdermal contraceptives; contraceptive implants or injections; intrauterine device; diaphragm/cervical cap/condom with spermicide
  • Other acceptable methods of birth control include: Postmenopausal or amenorrhea for one year, Surgically sterile (hysterectomy, tubal ligation, or oopherectomy), Premenarcheal
  • Able to speak, read and comprehend English and record requested measurements as outlined in the protocol
  • Subject must be able to read, understand, sign and date the informed consent document (and the subject assent form, if necessary) indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the trial
  • -

Who cannot join

  • Subjects meeting any of the following criteria will not be entered in the study:
  • Similar injury of the same joint within the last 6 months
  • Clinical evidence of complete rupture of ankle ligaments (third degree sprain)
  • Requirements for bed rest, hospitalization, or surgical intervention for the ankle injury
  • Evidence of fractures or non-removable full cast of any type
  • Presence of bilateral occurrence of ankle injury or ipsilateral ankle and/or knee injury
Show all 15Show fewer
  • Open wound or infection at site of injury
  • Significant Skin irritation at the application site;
  • Use of longer half life NSAID within 12 hours prior to study entry (Appendix 4)
  • Does not agree to use only supplied investigational product and rescue medication for analgesia during the seven days of the study or expects to require analgesics during the study for pain other than for ankle pain
  • Presence or history of allergy or intolerance to aspirin, NSAIDs, acetaminophen or any of the excipients in the investigational product (L-Arginine hydrochloride, Glyceryl Stearate, Cetyl Alcohol, Squalane, Xanthan Gum, Isopropyl Myristate, Oleic Acid, Propylene Glycol, Polysorbate -20)
  • Medical conditions including: peptic ulcer disease; clinically important gastrointestinal, renal, or hepatic disease within the past 6 months; clinically significant cardiovascular disease not stable for the past 6 months; uncontrolled hypertension as indicated by systolic blood pressure greater than or equal to 160 mmHg or a diastolic blood pressure greater than or equal to 100 mm Hg; coagulation disorders or hematologic disease; history of seizures; or known, significant, pre-existing conditions that would affect the interpretation of any potential adverse reactions to the study medication
  • Known alcohol abuse, drug dependency, or history of significant psychiatric illness within the past 12 months
  • Females who are pregnant or lactating.
  • -

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Ce3

    Guilford, Connecticut, 06437

Other trials in United States

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Multi-dose, Pivotal Study to Determine the Efficacy and Safety of SST 0225, a Topical Ibuprofen Cream, in the Treatment of Pain Associated With Acute Ankle Sprain.

This is a randomized, multi-center, double-blind, placebo-controlled, multi-dose, parallel-group study. Approximately 300 subjects (150 per group) 16 years of age and older with a current (within 24 hours from Visit 1) Grade I or II ankle sprain, and who meet all eligibility criteria, will be randomized into the study and will receive either the active treatment (SST-0225 ibuprofen cream), or matching placebo. Subjects will apply an amount equivalent to a 4 inch line of investigational product to the affected ankle approximately every 4-6 hours. At Visit 1 two doses will be applied at the site. All subsequent doses of the investigational product will be applied every 4 to 6 hours with a total of 4 doses in a 24 hour period. Duration of treatment with the investigational product is 7 days.

Being tested
Placebo, SST-0225 Topical Ibuprofen Cream
Keywords
acute ankle sprain, Grade I or Grade II
Medical subject headings
Lymphoma, Follicular

What participants receive

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

  • PlaceboDrug

    Placebo cream

  • SST-0225 Topical Ibuprofen CreamDrug

    Also called Ibuprofen

    SST-0225 Topical Ibuprofen Cream

Study groups in NCT01874626
Study groupRoleWhat they receive
ActiveActive comparatorSST-0225 Topical Ibuprofen Cream (investigational product) Dose: 2.7 grams of cream containing 200 mg ibuprofen
Receives: Drug: SST-0225 Topical Ibuprofen Cream
PlaceboPlacebo comparatorPlacebo topical formulation (Reference product)
Receives: Drug: Placebo

What is being measured

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

  1. 24 Hour SPID

    Tme weighted summed pain intensity on movement difference from baseline over the first 24 hours (SPID24) following the first application of study medication on Day 1

    Measured: 24 Hours

Secondary outcomes (8)

  1. Time to onset of confirmed perceptible pain relief and onset of meaningful pain relief

    • Time to onset of confirmed perceptible pain relief and onset of meaningful pain relief over the four-hour in-office phase of the study.

    Measured: First 4 hours

  2. Mean change from baseline in subject reported pain intensity

    • Mean change from baseline in subject reported pain intensity (at rest and on movement) and pain relief (on movement only) as assessed at 15 minutes, 30 minutes, and hourly up to 4 hours following the first application on Day 1.

    Measured: First 4 hours

  3. Mean change from baseline in pain scores on movement

    • Mean change from baseline in pain scores on movement at hours 6, 8, 10, 12, 20 and 24 hours over the first 24 hours.

    Measured: First 24 hours

  4. Percent of subjects with > 15%, > 30% and > 50% reductions in pain intensity

    • Percent of subjects with > 15%, > 30% and > 50% reductions in pain intensity from baseline at 24 hours.

    Measured: First 24 hours

  5. Subject's global evaluation of investigational product

    • Subject's global evaluation of investigational product evaluated at Days 2, 4 and 7 (or End-of-Study) based on a 5 point scale.

    Measured: 7 days

  6. Use of rescue medication including time to first use

    • Use of rescue medication including time to first use (first 12 hours), proportion of subjects using rescue and amount of rescue medication used.

    Measured: 7 days

  7. Change from baseline in pain scores on movement

    • Change from baseline in pain scores on movement at time of each dose on Days 2-7.

    Measured: 7 days

  8. Number and percent of patients with systemic and local (skin) self-reported adverse events

    Number and percent of patients with systemic and local (skin) self-reported adverse events.

    Measured: 7 days

Timeline

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

  1. First posted11 Jun 2013 (estimated)
  2. Study startJun 2013
  3. Primary completionJan 2014
  4. Study completionJan 2014

Resources

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, Care provider, Investigator
Enrolment
305 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01874626
Sponsor's protocol ID
SST0225-US-010-001
Status last verified
Jan 2014
First submitted
11 Oct 2012
Last updated
21 May 2021
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SST-0225 Topical Ibuprofen Cream in people with Acute Ankle Sprain, run by Strategic Science & Technologies, LLC 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 14 inclusion and 15 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 21 May 2021. 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?

24 Hour SPID (time frame: 24 Hours). 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 NCT01874626.

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 21 May 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in