PainPhase 4NCT00576173
An Open Label Study to Evaluate Safety, Tolerability and Clinical Utility of ULTRACET® (37.5mg Tramadol Hydrochloride/325mg Acetaminophen) for the Treatment of Breakthrough Pain in Cancer Patients
A Phase 4 study testing tramadol hydrochloride; acetaminophen in people with Pain, run by Johnson & Johnson Taiwan Ltd.
Trial summary
The purpose of this study is to evaluate the analgesic effectiveness and safety of 37.5mg Tramadol hydrochloride/325mg Acetaminophen in the treatment of breakthrough pain in cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- tramadol hydrochloride; acetaminophen
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Dec 2005to Feb 2007
- 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
- Patients with a histologically, radiologically or haematologically confirmed malignancy whose pain is judged by the investigator to be caused by the malignancy
- Patients must have been on a stable daily dose of weak opioids or strong opioids for at least 72 hours prior to the start the study and must remain at the same dosage for the duration of the study
- Patients must have a VAS (Visual analog scale) >=40mm
Who cannot join
- Patients who have taken either morphine with daily dose more than 120mg or Fentanyl with daily dose more than 50ug/hr
- Patients with significant abnormalities in hepatic or renal function which would, in the opinion of the investigator, prevent the patients involvement in the study
- Patients with significant clinical abnormalities in CNS, respiratory or cardiovascular function, which in the investigators judgement prevents participation in the study
- Patients who have taken antidepressants or anti-epileptic drugs, sedative hypnotics, selective serotonin reuptake inhibitor, short-acting analgesics, topical medications and anesthetics and/or muscle relaxants when taking Tramadol/Acetaminophen
About this study
The purpose of this study is to evaluate the analgesic effectiveness and safety of 37.5mg Tramadol hydrochloride/325mg Acetaminophen in the treatment of breakthrough pain in cancer patients.
Read the detailed description
The combination of tramadol HCI/acetaminophen provides a more rapid onset of action compared to tramadol HCI alone and a longer duration of action than acetaminophen alone. Therefore, the combination of tramadol and acetaminophen may be effective for the treatment of cancer pain as well as to allow lower cumulative daily dosages of each medication to be used.This is an open-label study. Patients will receive one-dose treatment of 37.5mg Tramadol/325mg Acetaminophen tablets.This study has been designed to investigate the following hypothesis:Tramadol hydrochloride/acetaminophen is effective in the treatment of breakthrough pain in cancer patients.The patients will complete basic questions on side effect at visits on entry, 10, 30 mins, and 1h.
The patients will receive only one dose treatment of Tramadol hydrochloride/Acetaminophen oral tablets throughout the study. The number of oral tablets be given will be depend on the total daily dose of around-clock medications. If around-clock medication is Tramadol <=400mg or codeine <=300mg or morphine <60mg, the breakthrough pain medication will be 1 tablet. If around-clock medication is morphine 60-120mg or Fentanyl >=25 ug/hr, the breakthrough pain medication will be 2 tablets.
- Conditions
- Pain
- Being tested
- tramadol hydrochloride; acetaminophen
- Keywords
- Cancer pain, Breakthrough pain, acetaminophen, tramadol hydrochloride, Ultracet
- Medical subject headings
- Pain, Cancer Pain, Breakthrough Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tramadol hydrochloride; acetaminophenDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity and side effect will be assessed on entry, 10, 30 mins, and 1hour. In addition, the amount of rescue analgesic medication consumed will be recorded by the patient and summarized by the investigator at study visits.
Secondary outcomes (1)
Investigator global assessment and patient global assessment for the treatment with respect to pain control, side effects and overall using a 5-point scale at the end of the treatment phase.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2007 (estimated)
- Study startDec 2005
- Study completionFeb 2007
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Taiwan Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Johnson & Johnson Taiwan, Ltd. Clinical Trial, Study director, Johnson & Johnson Taiwan Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00576173
- Sponsor's protocol ID
- CR014683
- Status last verified
- Apr 2010
- First submitted
- 14 Dec 2007
- Last updated
- 28 Apr 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Study to Evaluate Safety, Tolerability and Clinical Utility of ULTRACET® (37.5mg Tramadol Hydrochloride/325mg Acetaminophen) for the Treatment of Breakthrough Pain in Cancer Patients
- ClinicalTrials.gov ID
- NCT00576173
- Acronym / sponsor ID
- CR014683
- Conditions
- Pain
- Keywords
- Cancer pain, Breakthrough pain, acetaminophen, tramadol hydrochloride, Ultracet
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Johnson & Johnson Taiwan LtdIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Study completion
- Feb 2007 (actual)
- First posted
- 18 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.
The purpose of this study is to evaluate the analgesic effectiveness and safety of 37.5mg Tramadol hydrochloride/325mg Acetaminophen in the treatment of breakthrough pain in cancer patients.
Detailed description
The combination of tramadol HCI/acetaminophen provides a more rapid onset of action compared to tramadol HCI alone and a longer duration of action than acetaminophen alone. Therefore, the combination of tramadol and acetaminophen may be effective for the treatment of cancer pain as well as to allow lower cumulative daily dosages of each medication to be used.This is an open-label study. Patients will receive one-dose treatment of 37.5mg Tramadol/325mg Acetaminophen tablets.This study has been designed to investigate the following hypothesis:Tramadol hydrochloride/acetaminophen is effective in the treatment of breakthrough pain in cancer patients.The patients will complete basic questions on side effect at visits on entry, 10, 30 mins, and 1h.
The patients will receive only one dose treatment of Tramadol hydrochloride/Acetaminophen oral tablets throughout the study. The number of oral tablets be given will be depend on the total daily dose of around-clock medications. If around-clock medication is Tramadol <=400mg or codeine <=300mg or morphine <60mg, the breakthrough pain medication will be 1 tablet. If around-clock medication is morphine 60-120mg or Fentanyl >=25 ug/hr, the breakthrough pain medication will be 2 tablets.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with a histologically, radiologically or haematologically confirmed malignancy whose pain is judged by the investigator to be caused by the malignancy
- Patients must have been on a stable daily dose of weak opioids or strong opioids for at least 72 hours prior to the start the study and must remain at the same dosage for the duration of the study
- Patients must have a VAS (Visual analog scale) >=40mm
Key exclusion criteria (4 listed)
- Patients who have taken either morphine with daily dose more than 120mg or Fentanyl with daily dose more than 50ug/hr
- Patients with significant abnormalities in hepatic or renal function which would, in the opinion of the investigator, prevent the patients involvement in the study
- Patients with significant clinical abnormalities in CNS, respiratory or cardiovascular function, which in the investigators judgement prevents participation in the study
- Patients who have taken antidepressants or anti-epileptic drugs, sedative hypnotics, selective serotonin reuptake inhibitor, short-acting analgesics, topical medications and anesthetics and/or muscle relaxants when taking Tramadol/Acetaminophen
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 hydrochloride; acetaminophen | Drug | – |
Primary outcome
Pain intensity and side effect will be assessed on entry, 10, 30 mins, and 1hour. In addition, the amount of rescue analgesic medication consumed will be recorded by the patient and summarized by the investigator at study visits.
1 secondary outcome
Investigator global assessment and patient global assessment for the treatment with respect to pain control, side effects and overall using a 5-point scale at the end of the treatment phase.
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 28 Apr 2010.
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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 Taiwan, Ltd. Clinical Trial study director
Johnson & Johnson Taiwan Ltd
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing tramadol hydrochloride; acetaminophen in people with Pain, run by Johnson & Johnson Taiwan Ltd.
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 3 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 28 Apr 2010. 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?
Pain intensity and side effect will be assessed on entry, 10, 30 mins, and 1hour. In addition, the amount of rescue analgesic medication consumed will be recorded by the patient and summarized by the investigator at study visits.. 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 28 Apr 2010.