Soft Tissue InjuryNCT00567528
Comparison of the Efficacy of Topical Ibuprofen to Oral Ibuprofen in Adolescent Athletes
A study testing Ibuprofen in people with Soft Tissue Injury, run by Akron Children's Hospital at 1 site in United States.
Trial summary
This study was made to compare the efficacy of topical ibuprofen in gel form with oral ibuprofen in the treatment of sub-acute soft tissue injuries while comparing the tolerability of the delivery methods Read more about this study
- Who is it for?
- Ages 12 to 19 years
- Conditions the study is for
- Soft Tissue Injury
- What is being tested?
- Ibuprofen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to Apr 2009
- Phase
- Interventional
- 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 12 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 12-19yo
- soft tissue injury or flare up of soft tissue injury within 10 days to 8 weeks
Who cannot join
- Known hypersensitivity to aspirin or any NSAID,
- allergy to eggs or egg products
- history of asthma, renal disease, GI disease, active or suspected bleeding peptic ulcer (past or present), anemia, hypertension, other systemic disease significantly affecting liver or renal function
- serious injury within six months
- currently on anticoagulants
- pregnant or lactating females
Show all 11Show fewer
- active arthritis in affected limb
- open wounds, infected skin or fractures
- opioid use within 7 days
- severe psychological disorder
- prior topical medication applied to the painful region/area of study
Trial locations and contacts
1 site in 1 country.
United States1 site
Sports Medicine Department at Akron Children's Hospital
Akron, Ohio, 44308
About this study
This study was made to compare the efficacy of topical ibuprofen in gel form with oral ibuprofen in the treatment of sub-acute soft tissue injuries while comparing the tolerability of the delivery methods
- Conditions
- Soft Tissue Injury
- Being tested
- Ibuprofen
- Keywords
- Soft tissue injuries, Topical ibuprofen, Adolescent athletes
- Medical subject headings
- Soft Tissue Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbuprofenDrug
Apply by rubbing into skin for 30 to 60 seconds placebo ibuprofen 10% gel, 0.5cc to skin over injured area 3 times a day and taking active capsules of ibuprofen 3 times a day 10-40mg/kg per day, not to exceed 1200mg per day for 2 weeks.
ibuprofenDrug
Apply by rubbing into skin for 30 to 60 seconds active ibuprofen 10% gel, 0.5cc to skin over injured area 3 times a day and taking placebo capsules of ibuprofen 3 times a day 10-40mg/kg per day, not to exceed 1200mg per day for 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Active ibuprofen liposomal transdermal gel with placebo ibuprofen capsule Receives: Drug: ibuprofen |
| 2 | Other | Placebo ibuprofen liposomal transdermal gel with active ibuprofen capsules Receives: Drug: Ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Topical Ibuprofen to Oral Ibuprofen measured by numeric pain rating, swelling at injury site, and change in sports activity.
Measured: 10 days to 8 weeks after initial injury or flare up
Secondary outcomes (1)
Compare the tolerability of the two delivery methods measured by side effects.
Measured: 2 weeks after starting topical and oral ibuprofen
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2007 (estimated)
- Study startMay 2006
- Primary completionApr 2009
- Study completionApr 2009
Why it stopped: Study was not producing meaningful data.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Soft Tissue InjuryStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akron Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eloise Lemon, Akron Children's Hospital
- Investigators
- Emmanuel O Adekunle, M.D., Principal investigator, Akron Children's HospitalJoseph Congeni, M.D., Study director, Akron Children's HospitalCynthia Bennett, MSN, CNP, Principal investigator, Akron Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00567528
- Sponsor's protocol ID
- IRB #0600210
- Status last verified
- Jan 2012
- First submitted
- 3 Dec 2007
- Last updated
- 14 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Whitefield M, O'Kane CJ, Anderson S. Comparative efficacy of a proprietary topical ibuprofen gel and oral ibuprofen in acute soft tissue injuries: a randomized, double-blind study. J Clin Pharm Ther. 2002 Dec;27(6):409-17. doi: 10.1046/j.1365-2710.2002.00439.x.
PubMed 12472980
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Topical Ibuprofen to Oral Ibuprofen in Adolescent Athletes
- ClinicalTrials.gov ID
- NCT00567528
- Acronym / sponsor ID
- IRB #0600210
- Conditions
- Soft Tissue Injury
- Keywords
- Soft tissue injuries, Topical ibuprofen, Adolescent athletes
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was not producing meaningful data.
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Akron Children's HospitalUniversity, hospital or other
- Study start
- May 2006
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 5 Dec 2007 (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.
This study was made to compare the efficacy of topical ibuprofen in gel form with oral ibuprofen in the treatment of sub-acute soft tissue injuries while comparing the tolerability of the delivery methods
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Drug: ibuprofenActive ibuprofen liposomal transdermal gel with placebo ibuprofen capsule |
| 2 | Other | Drug: IbuprofenPlacebo ibuprofen liposomal transdermal gel with active ibuprofen capsules |
Who may qualify
- Ages
- 12 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Age 12-19yo
- soft tissue injury or flare up of soft tissue injury within 10 days to 8 weeks
Key exclusion criteria (11 listed)
- Known hypersensitivity to aspirin or any NSAID,
- allergy to eggs or egg products
- history of asthma, renal disease, GI disease, active or suspected bleeding peptic ulcer (past or present), anemia, hypertension, other systemic disease significantly affecting liver or renal function
- serious injury within six months
- currently on anticoagulants
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 |
|---|---|---|
| IbuprofenApply by rubbing into skin for 30 to 60 seconds placebo ibuprofen 10% gel, 0.5cc to skin over injured area 3 times a day and taking active capsules of ibuprofen 3 times a day 10-40mg/kg per day, not to exceed 1200mg per day for 2 weeks. | Drug | 2 |
| ibuprofenApply by rubbing into skin for 30 to 60 seconds active ibuprofen 10% gel, 0.5cc to skin over injured area 3 times a day and taking placebo capsules of ibuprofen 3 times a day 10-40mg/kg per day, not to exceed 1200mg per day for 2 weeks. | Drug | 1 |
Primary outcome
Efficacy of Topical Ibuprofen to Oral Ibuprofen measured by numeric pain rating, swelling at injury site, and change in sports activity.
Time frame: 10 days to 8 weeks after initial injury or flare up
1 secondary outcome
Compare the tolerability of the two delivery methods measured by side effects.
Time frame: 2 weeks after starting topical and oral ibuprofen
Results and safety
The study was stopped early (reason given: Study was not producing meaningful data.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2015.
- Background: PubMed 12472980Whitefield M, O'Kane CJ, Anderson S. Comparative efficacy of a proprietary topical ibuprofen gel and oral ibuprofen in acute soft tissue injuries: a randomized, double-blind study. J Clin Pharm Ther. 2002 Dec;27(6):409-17. doi: 10.1046/j.1365-2710.2002.00439.x.
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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.
Emmanuel O Adekunle, M.D. principal investigator
Akron Children's Hospital
Joseph Congeni, M.D. study director
Akron Children's Hospital
Cynthia Bennett, MSN, CNP principal investigator
Akron Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ibuprofen in people with Soft Tissue Injury, run by Akron Children's Hospital 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 2 inclusion and 11 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 14 Jan 2015. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study was not producing meaningful data.). 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?
Efficacy of Topical Ibuprofen to Oral Ibuprofen measured by numeric pain rating, swelling at injury site, and change in sports activity. (time frame: 10 days to 8 weeks after initial injury or flare up). 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 NCT00567528, which also lists 1 linked publication.
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 14 Jan 2015.