PainPhase 4NCT00240838
An Effectiveness and Safety Study Comparing Acetaminophen (3900 mg/Day) to Ibuprofen (1200 mg/Day) in the Treatment of Post-Race Muscle Soreness.
A Phase 4 study testing acetaminophen extended release caplets in people with Pain, run by Johnson & Johnson Consumer and Personal Products Worldwide.
Trial summary
The purpose of this study is to compare the effectiveness and safety of acetaminophen extended release caplets and ibuprofen in relieving the muscle soreness that occurs after a marathon. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- acetaminophen extended release caplets
- How many people
- 483 participants
- Where
- No sites listed yet
- Study dates
- May 2003to Jun 2003
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients must complete the marathon
- be able to swallow the study medication
- comply with study requirements regarding the use of any other pain medications before, during or after the marathon
- rate their muscle soreness on the evening after the marathon as at least a 4, on a zero-to-ten point scale
- if female, must not be pregnant or breastfeeding, and must be using an acceptable form of contraception
Who cannot join
- Previous diagnosis of osteoarthritis requiring pain medication therapy
- currently have a major medical illness
- have a history of cardiovascular disease, heat injury (heat exhaustion or heat stroke) or collapse during a running or endurance event
- known hypersensitivity to acetaminophen or ibuprofen
About this study
Official title: A Randomized, Double-Blind Study Evaluating Acetaminophen Extended Release Caplets (3900 mg/Day) and Ibuprofen (1200 mg/Day) in the Treatment of Post-Race Muscle Soreness.
The purpose of this study is to compare the effectiveness and safety of acetaminophen extended release caplets and ibuprofen in relieving the muscle soreness that occurs after a marathon.
Read the detailed description
The objective of this randomized, double-blind study is to compare the effectiveness and safety of acetaminophen extended release caplets and ibuprofen in relieving the muscle soreness that occurs in subjects who complete a marathon. Subjects are randomized to receive acetaminophen extended release caplets, 3900 mg/day (two 650 mg caplets taken three times a day, for five days) or ibuprofen caplets, 1200 mg/day (two 200 mg caplets taken three times a day, for five days). The primary measurement of efficacy is the average change in muscle soreness from baseline for both the morning and evening assessments. Safety assessments consist of monitoring adverse events, and a physical examination including vital signs, weight, a review of concomitant medications, and a urine pregnancy test for female subjects. Two hypotheses are examined in a step-down approach. The first hypothesis is that acetaminophen extended release is not inferior to ibuprofen in relieving the muscle soreness that occurs after a marathon. If acetaminophen extended release is not inferior to ibuprofen in relieving the muscle soreness that occurs after a marathon, the second hypothesis is that acetaminophen extended release (3900 mg/day) is superior to ibuprofen (1200 mg/day) in relieving the muscle soreness that occurs after a marathon. Two acetaminophen 650 mg extended release caplets, taken by mouth, three times a day for five days or two ibuprofen 200 mg caplets, taken by mouth, three times a day for five days.
- Conditions
- Pain
- Being tested
- acetaminophen extended release caplets
- Keywords
- muscle soreness, pain, acetaminophen, ibuprofen
- Medical subject headings
- Pain, Myalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acetaminophen extended release capletsDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Average change in muscle soreness from baseline for both morning and evening assessments.
Secondary outcomes (1)
Average change in muscle soreness from baseline for morning assessments; Average change in muscle soreness from baseline for evening assessments; Average ratings of interference with 1) sleep; 2) morning activity; 3) ability to go for a run
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2005 (estimated)
- Study startMay 2003
- Study completionJun 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 483 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
- NCT00240838
- Sponsor's protocol ID
- CR002866
- Status last verified
- Jun 2011
- First submitted
- 14 Oct 2005
- Last updated
- 29 Jun 2011
- Results posted
- No
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 Study Evaluating Acetaminophen Extended Release Caplets (3900 mg/Day) and Ibuprofen (1200 mg/Day) in the Treatment of Post-Race Muscle Soreness.
- ClinicalTrials.gov ID
- NCT00240838
- Acronym / sponsor ID
- CR002866
- Conditions
- Pain
- Keywords
- muscle soreness, pain, acetaminophen, ibuprofen
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 483 participants (actual)
- Lead sponsor
- Johnson & Johnson Consumer and Personal Products WorldwideIndustry (pharma, biotech, devices)
- Study start
- May 2003
- Study completion
- Jun 2003 (actual)
- First posted
- 18 Oct 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 effectiveness and safety of acetaminophen extended release caplets and ibuprofen in relieving the muscle soreness that occurs after a marathon.
Detailed description
The objective of this randomized, double-blind study is to compare the effectiveness and safety of acetaminophen extended release caplets and ibuprofen in relieving the muscle soreness that occurs in subjects who complete a marathon. Subjects are randomized to receive acetaminophen extended release caplets, 3900 mg/day (two 650 mg caplets taken three times a day, for five days) or ibuprofen caplets, 1200 mg/day (two 200 mg caplets taken three times a day, for five days). The primary measurement of efficacy is the average change in muscle soreness from baseline for both the morning and evening assessments. Safety assessments consist of monitoring adverse events, and a physical examination including vital signs, weight, a review of concomitant medications, and a urine pregnancy test for female subjects. Two hypotheses are examined in a step-down approach. The first hypothesis is that acetaminophen extended release is not inferior to ibuprofen in relieving the muscle soreness that occurs after a marathon. If acetaminophen extended release is not inferior to ibuprofen in relieving the muscle soreness that occurs after a marathon, the second hypothesis is that acetaminophen extended release (3900 mg/day) is superior to ibuprofen (1200 mg/day) in relieving the muscle soreness that occurs after a marathon. Two acetaminophen 650 mg extended release caplets, taken by mouth, three times a day for five days or two ibuprofen 200 mg caplets, taken by mouth, three times a day for five 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
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients must complete the marathon
- be able to swallow the study medication
- comply with study requirements regarding the use of any other pain medications before, during or after the marathon
- rate their muscle soreness on the evening after the marathon as at least a 4, on a zero-to-ten point scale
- if female, must not be pregnant or breastfeeding, and must be using an acceptable form of contraception
Key exclusion criteria (4 listed)
- Previous diagnosis of osteoarthritis requiring pain medication therapy
- currently have a major medical illness
- have a history of cardiovascular disease, heat injury (heat exhaustion or heat stroke) or collapse during a running or endurance event
- known hypersensitivity to acetaminophen or ibuprofen
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 extended release caplets | Drug | – |
Primary outcome
Average change in muscle soreness from baseline for both morning and evening assessments.
1 secondary outcome
Average change in muscle soreness from baseline for morning assessments; Average change in muscle soreness from baseline for evening assessments; Average ratings of interference with 1) sleep; 2) morning activity; 3) ability to go for a run
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.
- An Effectiveness and Safety Study comparing Acetaminophen (3900 mg/day) to Ibuprofen (1200 mg/day) in the Treatment of Post-Race Muscle Soreness.Link provided by the sponsor.
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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 extended release caplets in people with 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 5 inclusion and 4 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?
Average change in muscle soreness from baseline for both morning and evening assessments.. 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 29 Jun 2011.