Sprains and StrainsPhase 3NCT00236535
A Study of the Efficacy and Safety of Tramadol HCl/Acetaminophen, Hydrocodone Bitartrate/Acetaminophen and Placebo in Patients With Pain From an Ankle Sprain With a Partial Torn Ligament
A Phase 3 study of Sprains and Strains and Pain, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial summary
The purpose of this study is to explore the pain-relieving effects and safety of two analgesic treatment regimens as compared to placebo in patients experiencing acute musculoskeletal pain. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sprains and Strains, Pain
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 603 participants
- Where
- No sites listed yet
- Study dates
- Dec 2003to Oct 2004
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of acute ankle sprain with a partial ligament tear within 48 hours of study entry
- At least moderate pain from the ankle sprain at baseline and before first dose of study medication
- In generally good health
- If female of childbearing potential, using acceptable method of birth control
Who cannot join
- Use of ibuprofen within 6 hours or topical pain relievers within 12 hours of study entry
- Use of tramadol HCl, tramadol HCl/acetaminophen, or hydrocodone bitartrate/acetaminophen within 30 days of study entry
- Use of epilepsy or antidepressant medications 3 weeks before the study entry
- Chronic use of pain medications or muscle relaxants for any reason during the study
- No use of steroid medications (oral or inhaled) on a chronic basis
- Required hospitalization to treat the ankle sprain
Show all 16Show fewer
- Head trauma
- Pain greater than the pain caused by the ankle sprain
- Complete ligament tear
- Bone fractures on x-ray
- Required physical therapy, other than for crutch training
- History of kidney damage
- Pregnant or breast-feeding patients
- Condition that might affect the way the body absorbs or processes the study medication
- Major psychiatric disorder, history of attempted suicides/suicidal tendencies
- History of substance abuse or chronic alcohol abuse in the past 6 months
About this study
Official title: A Comparison of the Efficacy and Safety of Tramadol HCl/Acetaminophen Versus Hydrocodone Bitartrate/Acetaminophen Versus Placebo in Subjects With Acute Musculoskeletal Pain
The purpose of this study is to explore the pain-relieving effects and safety of two analgesic treatment regimens as compared to placebo in patients experiencing acute musculoskeletal pain. Patients who are experiencing at least moderate acute musculoskeletal pain from an ankle sprain severe enough to require prescription pain relief medication will be randomized to receive either tramadol HCl/acetaminophen, hydrocodone bitartrate/acetaminophen or placebo.
Read the detailed description
Tramadol HCl/acetaminophen is approved for short-term (five days or less) management of acute pain. The combination of tramadol HCl/acetaminophen provides a more rapid onset of action compared with tramadol HCl alone and a longer duration of action than acetaminophen alone. Therefore, the combination of tramadol HCl/acetaminophen may be effective for the treatment of acute musculoskeletal pain. The current study is a multicenter, randomized, double-blind, inpatient/outpatient, active-controlled, placebo-controlled, parallel-group study. Patients who are experiencing at least moderate acute musculoskeletal pain from an ankle sprain severe enough to require prescription medication will be enrolled. Patients will be randomized to receive either oral tramadol HCl/acetaminophen, hydrocodone bitartrate/acetaminophen or placebo. Patients will receive 2 capsules tramadol HCl/acetaminophen 37.5/325 milligrams or 1 capsule hydrocodone bitartrate/acetaminophen 7.5/650 milligrams + 1 capsule placebo or 2 capsules placebo. Patient may take 1 or 2 capsules up to 4 times daily as needed but no more than 8 capsules per day for 5 daysThe first dose of study medication will be given at the study site. Patients will complete a Pain Visual Analog Scale, Pain Relief Rating Scale and Pain Intensity Scale at 1, 2, 3 and 4 hours after the first dose of study medication. On Day 1, after the 4-hour evaluations, patients will be dispensed study medication for use throughout the rest of the study. Patients will also evaluate and record in a daily diary the pain intensity ratings and pain relief scores for Days 1-5 of the double-blind phase. At the final visit, patients will complete a Pain Intensity Scale and Pain Relief Rating Scale, an Activity Impairment Assessment and a Subject Overall Medication Assessment. At the first dose, patients are dispensed 2 capsules of study medication. Thereafter, patients may take 1 or 2 capsules of study medication orally up to 4 times per day, as needed for pain, but no more than 8 capsules per day. The objective of this study is to compare the pain-relieving effectiveness and safety of tramadol HCl/acetaminophen versus hydrocodone bitartrate/acetaminophen versus placebo for the treatment of acute musculoskeletal pain from an ankle sprain with a partial ligament tear.
2 capsules tramadol HCl/acetaminophen 37.5/325 milligrams or 1 capsule hydrocodone bitartrate/acetaminophen 7.5/650 milligrams + 1 capsule placebo or 2 capsules placebo; patient may take 1 or 2 capsules orally up to 4 times daily as needed but no more than 8 capsules per day for 5 days
- Conditions
- Sprains and Strains, Pain
- Being tested
- tramadol HCl + acetaminophen; hydrocodone bitartrate + acetaminophen; placebo
- Keywords
- musculoskeletal, Pain, sprained ankle, ligament, sprain, ankle
- 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.
tramadol HCl + acetaminophen; hydrocodone bitartrate + acetaminophen; placeboDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Total pain relief (TOTPAR) over 4 hours on Day 1 after the administration of the first dose of study medication
Secondary outcomes (1)
Sum of Pain Intensity Differences; Sum of Pain Relief Intensity Differences; Pain Visual Analog Scores; mean daily pain intensity and relief; final pain intensity, relief and activity impairment assessment; subject overall medication assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2005 (estimated)
- Study startDec 2003
- Study completionOct 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 603 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PriCara, Unit of Ortho-McNeil, Inc.
- Investigators
- Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00236535
- Sponsor's protocol ID
- CR002815
- Status last verified
- Apr 2010
- First submitted
- 7 Oct 2005
- Last updated
- 10 Jun 2011
- Results posted
- No
Publications
Hewitt DJ, Todd KH, Xiang J, Jordan DM, Rosenthal NR; CAPSS-216 Study Investigators. Tramadol/acetaminophen or hydrocodone/acetaminophen for the treatment of ankle sprain: a randomized, placebo-controlled trial. Ann Emerg Med. 2007 Apr;49(4):468-80, 480.e1-2. doi: 10.1016/j.annemergmed.2006.08.030. Epub 2006 Nov 20.
PubMed 17113683
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Efficacy and Safety of Tramadol HCl/Acetaminophen Versus Hydrocodone Bitartrate/Acetaminophen Versus Placebo in Subjects With Acute Musculoskeletal Pain
- ClinicalTrials.gov ID
- NCT00236535
- Acronym / sponsor ID
- CR002815
- Conditions
- Sprains and Strains, Pain
- Keywords
- musculoskeletal, Pain, sprained ankle, ligament, sprain, ankle
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 603 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Collaborators
- PriCara, Unit of Ortho-McNeil, Inc.
- Study start
- Dec 2003
- Study completion
- Oct 2004 (actual)
- First posted
- 12 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 explore the pain-relieving effects and safety of two analgesic treatment regimens as compared to placebo in patients experiencing acute musculoskeletal pain. Patients who are experiencing at least moderate acute musculoskeletal pain from an ankle sprain severe enough to require prescription pain relief medication will be randomized to receive either tramadol HCl/acetaminophen, hydrocodone bitartrate/acetaminophen or placebo.
Detailed description
Tramadol HCl/acetaminophen is approved for short-term (five days or less) management of acute pain. The combination of tramadol HCl/acetaminophen provides a more rapid onset of action compared with tramadol HCl alone and a longer duration of action than acetaminophen alone. Therefore, the combination of tramadol HCl/acetaminophen may be effective for the treatment of acute musculoskeletal pain. The current study is a multicenter, randomized, double-blind, inpatient/outpatient, active-controlled, placebo-controlled, parallel-group study. Patients who are experiencing at least moderate acute musculoskeletal pain from an ankle sprain severe enough to require prescription medication will be enrolled. Patients will be randomized to receive either oral tramadol HCl/acetaminophen, hydrocodone bitartrate/acetaminophen or placebo. Patients will receive 2 capsules tramadol HCl/acetaminophen 37.5/325 milligrams or 1 capsule hydrocodone bitartrate/acetaminophen 7.5/650 milligrams + 1 capsule placebo or 2 capsules placebo. Patient may take 1 or 2 capsules up to 4 times daily as needed but no more than 8 capsules per day for 5 daysThe first dose of study medication will be given at the study site. Patients will complete a Pain Visual Analog Scale, Pain Relief Rating Scale and Pain Intensity Scale at 1, 2, 3 and 4 hours after the first dose of study medication. On Day 1, after the 4-hour evaluations, patients will be dispensed study medication for use throughout the rest of the study. Patients will also evaluate and record in a daily diary the pain intensity ratings and pain relief scores for Days 1-5 of the double-blind phase. At the final visit, patients will complete a Pain Intensity Scale and Pain Relief Rating Scale, an Activity Impairment Assessment and a Subject Overall Medication Assessment. At the first dose, patients are dispensed 2 capsules of study medication. Thereafter, patients may take 1 or 2 capsules of study medication orally up to 4 times per day, as needed for pain, but no more than 8 capsules per day. The objective of this study is to compare the pain-relieving effectiveness and safety of tramadol HCl/acetaminophen versus hydrocodone bitartrate/acetaminophen versus placebo for the treatment of acute musculoskeletal pain from an ankle sprain with a partial ligament tear.
2 capsules tramadol HCl/acetaminophen 37.5/325 milligrams or 1 capsule hydrocodone bitartrate/acetaminophen 7.5/650 milligrams + 1 capsule placebo or 2 capsules placebo; patient may take 1 or 2 capsules orally up to 4 times daily as needed but no more than 8 capsules per day for 5 days
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of acute ankle sprain with a partial ligament tear within 48 hours of study entry
- At least moderate pain from the ankle sprain at baseline and before first dose of study medication
- In generally good health
- If female of childbearing potential, using acceptable method of birth control
Key exclusion criteria (16 listed)
- Use of ibuprofen within 6 hours or topical pain relievers within 12 hours of study entry
- Use of tramadol HCl, tramadol HCl/acetaminophen, or hydrocodone bitartrate/acetaminophen within 30 days of study entry
- Use of epilepsy or antidepressant medications 3 weeks before the study entry
- Chronic use of pain medications or muscle relaxants for any reason during the study
- No use of steroid medications (oral or inhaled) on a chronic basis
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 |
|---|---|---|
| tramadol HCl + acetaminophen; hydrocodone bitartrate + acetaminophen; placebo | Drug | – |
Primary outcome
Total pain relief (TOTPAR) over 4 hours on Day 1 after the administration of the first dose of study medication
1 secondary outcome
Sum of Pain Intensity Differences; Sum of Pain Relief Intensity Differences; Pain Visual Analog Scores; mean daily pain intensity and relief; final pain intensity, relief and activity impairment assessment; subject overall medication assessment
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 10 Jun 2011.
- Results publication: PubMed 17113683Hewitt DJ, Todd KH, Xiang J, Jordan DM, Rosenthal NR; CAPSS-216 Study Investigators. Tramadol/acetaminophen or hydrocodone/acetaminophen for the treatment of ankle sprain: a randomized, placebo-controlled trial. Ann Emerg Med. 2007 Apr;49(4):468-80, 480.e1-2. doi: 10.1016/j.annemergmed.2006.08.030. Epub 2006 Nov 20.
- A Comparison of the Efficacy and Safety of Tramadol HCl / Acetaminophen Versus Hydrocodone Bitartrate / Acetaminophen Versus Placebo in Subjects with Acute Musculoskeletal PainLink 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.
Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Sprains and Strains and Pain, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
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 16 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 10 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 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?
Total pain relief (TOTPAR) over 4 hours on Day 1 after the administration of the first dose of study medication. 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 NCT00236535, 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 10 Jun 2011.