Sprains and StrainsPhase 4NCT00261560
A Safety and Effectiveness Study of Acetaminophen Extended Release (3900 mg/Day) and Ibuprofen (1200 mg/Day) in the Treatment of Pain Associated With Ankle Sprains.
A Phase 4 study testing acetaminophen in people with Sprains and Strains and Pain, run by Johnson & Johnson Consumer and Personal Products Worldwide.
Trial summary
The purpose of this study is to compare the safety and effectiveness of 1300 mg acetaminophen extended release given three times daily for nine days to that of 400 mg ibuprofen given three times daily for nine days for the signs and symptoms of (Grade I and Grade II) lateral ankle sprains. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sprains and Strains, Pain
- What is being tested?
- acetaminophen
- How many people
- 260 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Feb 2004
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have had an ankle sprain within 24 hours of study entry
- have ankle pain when walking
- have not recently used non-steroidal, anti-inflammatory drugs (NSAIDs), other pain relieving medications (including acetaminophen) or medicines that could interfere with the assessment of effectiveness
- if female, must not be pregnant or breastfeeding
Who cannot join
- Ankle sprain was the second ankle sprain within six months
- Both ankles were sprained
- Ankle sprain occurred on the same side of the body as a knee injury
- Ankle injury requires bed rest, hospitalization, surgical intervention, or use of a non-removable rigid cylindrical cast
- Subject reports severe or very severe pain at rest on a five-point scale of none, mild, moderate, severe or very severe
About this study
Official title: A Randomized, Double-Blind, Parallel-Group Study Comparing the Safety and Effectiveness of Acetaminophen Extended Release (3900 mg/Day) and Ibuprofen (1200 mg/Day) in the Treatment of Ankle Sprains.
The purpose of this study is to compare the safety and effectiveness of 1300 mg acetaminophen extended release given three times daily for nine days to that of 400 mg ibuprofen given three times daily for nine days for the signs and symptoms of (Grade I and Grade II) lateral ankle sprains.
Read the detailed description
The objective of this randomized, double-blind, parallel-group study is to compare the safety and effectiveness of 1300 mg acetaminophen extended release given three times daily for nine days to that of 400 mg ibuprofen given three times daily for nine days for the signs and symptoms of Grade I and Grade II lateral ankle sprains. The primary efficacy endpoint is the change from baseline (Day 1) to Day 4 in the subjects' pain upon walking. Safety assessments consist of the monitoring of adverse events and assessments of the ankle injury during the course of the study. Two hypotheses are examined using a step down approach. The first hypothesis is that acetaminophen extended release is not inferior to ibuprofen in relieving the pain associated with (Grade I or Grade II) lateral ankle sprains. If acetaminophen extended release is not inferior to ibuprofen in relieving the pain associated with Grade I or Grade II lateral ankle sprains, the second hypothesis is that acetaminophen extended release is superior to ibuprofen in relieving the pain associated with Grade I or Grade II lateral ankle sprains. Two acetaminophen 650 mg extended release caplets, taken by mouth, three times a day for nine days or two ibuprofen 200 mg caplets, taken by mouth, three times a day for nine days
- Conditions
- Sprains and Strains, Pain
- Being tested
- acetaminophen
- Keywords
- ankle sprain, acetaminophen extended release, ibuprofen
- Medical subject headings
- Sprains and Strains, Pain, Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acetaminophenDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline (Day 1) to Day 4 in the subject's pain upon walking using a 0 to 100 mm visual analogue scale.
Secondary outcomes (1)
Change from baseline to Day 9 in pain upon walking; change from baseline to Day 4 and 9 in: ability to walk, ankle swelling, ankle bruising, and ankle's range of motion; overall satisfaction with treatment from Day 1 to Day 4 and Day 1 to Day 9.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2005 (estimated)
- Study completionFeb 2004
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 Sprains and StrainsStudies 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
- Double blind
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Consumer and Personal Products Worldwide
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- McNeil Consumer & Specialty Pharmaceuticals, a Division of Mc Neil-PPC, Inc. Clinical Trial, Study director, McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00261560
- Sponsor's protocol ID
- CR002824
- Status last verified
- Jun 2011
- First submitted
- 2 Dec 2005
- Last updated
- 29 Jun 2011
- Results posted
- No
Publications
Dalton JD Jr, Schweinle JE. Randomized controlled noninferiority trial to compare extended release acetaminophen and ibuprofen for the treatment of ankle sprains. Ann Emerg Med. 2006 Nov;48(5):615-23. doi: 10.1016/j.annemergmed.2006.05.015. Epub 2006 Sep 1.
PubMed 17052565
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Parallel-Group Study Comparing the Safety and Effectiveness of Acetaminophen Extended Release (3900 mg/Day) and Ibuprofen (1200 mg/Day) in the Treatment of Ankle Sprains.
- ClinicalTrials.gov ID
- NCT00261560
- Acronym / sponsor ID
- CR002824
- Conditions
- Sprains and Strains, Pain
- Keywords
- ankle sprain, acetaminophen extended release, ibuprofen
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Johnson & Johnson Consumer and Personal Products WorldwideIndustry (pharma, biotech, devices)
- Study completion
- Feb 2004 (actual)
- First posted
- 5 Dec 2005 (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 purpose of this study is to compare the safety and effectiveness of 1300 mg acetaminophen extended release given three times daily for nine days to that of 400 mg ibuprofen given three times daily for nine days for the signs and symptoms of (Grade I and Grade II) lateral ankle sprains.
Detailed description
The objective of this randomized, double-blind, parallel-group study is to compare the safety and effectiveness of 1300 mg acetaminophen extended release given three times daily for nine days to that of 400 mg ibuprofen given three times daily for nine days for the signs and symptoms of Grade I and Grade II lateral ankle sprains. The primary efficacy endpoint is the change from baseline (Day 1) to Day 4 in the subjects' pain upon walking. Safety assessments consist of the monitoring of adverse events and assessments of the ankle injury during the course of the study. Two hypotheses are examined using a step down approach. The first hypothesis is that acetaminophen extended release is not inferior to ibuprofen in relieving the pain associated with (Grade I or Grade II) lateral ankle sprains. If acetaminophen extended release is not inferior to ibuprofen in relieving the pain associated with Grade I or Grade II lateral ankle sprains, the second hypothesis is that acetaminophen extended release is superior to ibuprofen in relieving the pain associated with Grade I or Grade II lateral ankle sprains. Two acetaminophen 650 mg extended release caplets, taken by mouth, three times a day for nine days or two ibuprofen 200 mg caplets, taken by mouth, three times a day for nine days
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have had an ankle sprain within 24 hours of study entry
- have ankle pain when walking
- have not recently used non-steroidal, anti-inflammatory drugs (NSAIDs), other pain relieving medications (including acetaminophen) or medicines that could interfere with the assessment of effectiveness
- if female, must not be pregnant or breastfeeding
Key exclusion criteria (5 listed)
- Ankle sprain was the second ankle sprain within six months
- Both ankles were sprained
- Ankle sprain occurred on the same side of the body as a knee injury
- Ankle injury requires bed rest, hospitalization, surgical intervention, or use of a non-removable rigid cylindrical cast
- Subject reports severe or very severe pain at rest on a five-point scale of none, mild, moderate, severe or very severe
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 |
|---|---|---|
| acetaminophen | Drug | – |
Primary outcome
Change from baseline (Day 1) to Day 4 in the subject's pain upon walking using a 0 to 100 mm visual analogue scale.
1 secondary outcome
Change from baseline to Day 9 in pain upon walking; change from baseline to Day 4 and 9 in: ability to walk, ankle swelling, ankle bruising, and ankle's range of motion; overall satisfaction with treatment from Day 1 to Day 4 and Day 1 to Day 9.
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 29 Jun 2011.
- Results publication: PubMed 17052565Dalton JD Jr, Schweinle JE. Randomized controlled noninferiority trial to compare extended release acetaminophen and ibuprofen for the treatment of ankle sprains. Ann Emerg Med. 2006 Nov;48(5):615-23. doi: 10.1016/j.annemergmed.2006.05.015. Epub 2006 Sep 1.
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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.
McNeil Consumer & Specialty Pharmaceuticals, a Division of Mc Neil-PPC, Inc. Clinical Trial study director
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing acetaminophen in people with Sprains and Strains and Pain, run by Johnson & Johnson Consumer and Personal Products Worldwide.
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 4 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 29 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
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 from baseline (Day 1) to Day 4 in the subject's pain upon walking using a 0 to 100 mm visual analogue scale.. 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 NCT00261560, 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 29 Jun 2011.