CancerPhase 4NCT01968018
A Study of Safety and Effectiveness of Ultracet in Patients With Chronic Cancer Pain
A Phase 4 study testing Tramadol HCI/acetaminophen in people with Cancer, run by Janssen-Cilag Ltd.,Thailand at 1 site in Thailand.
Trial summary
The purpose of this study is to evaluate the analgesic (painkiller) effectiveness and safety of combination of tramadol HCI (37.5 mg)/acetaminophen (325 mg) in the treatment of chronic cancer pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Tramadol HCI/acetaminophen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteThailand
- Study dates
- Jul 2004to Apr 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
- Participants whose pain has reached a stage now requiring treatment with a weak opioid, according to the opinion of treating physician
- Participants who have received a regular weak opioid, for at least 48 hours and at a dosage appropriate for their pain at that time
- Participants with a histologically, radiologically or hematologically confirmed malignancy; whose pain is judged by the investigator to be caused by the malignancy
Who cannot join
- Participants who have already received regular treatment with a strong opioid for their cancer pain. This should not exceed more than 3 doses of a strong immediate release opiod in last 7 days, and none in last 24 hours
- Participants with significant abnormalities in hepatic or renal function which would in the opinion of the investigator, prevent the participants involvement in the study
- Participants with a history of allergy or hypersensitivity to tramadol or acetaminophen
- Participants who, at entry have treatments planned which may alter abruptly, the degree or nature of pain experienced (eg radiotherapy, neurological techniques surgery)
- Participants with a history of abuse of opioid analgesics prior to their diagnosis of cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study of Safety and Efficacy of Ultracet in Patients With Chronic Cancer Pain
The purpose of this study is to evaluate the analgesic (painkiller) effectiveness and safety of combination of tramadol HCI (37.5 mg)/acetaminophen (325 mg) in the treatment of chronic cancer pain.
Read the detailed description
This is an open-label (all people know the identity of the intervention) study. A total of 35 participants will be enrolled in this study. Participants will receive tablet of combination of tramadol HCI (37.5 mg)/acetaminophen (325 mg) on Day 1. Participants may increase their daily dosage of study medication as 1 to 2 tablets every 4 to 6 hours as needed for pain relief, up to maximum of 8 tablets per day. Rescue medication consisting of Extra Strength Tylenol (500 mg) 2 tablets daily for the first six days of the Open-label Phase will be allowed so that the total daily dose of acetaminophen will not exceed 4,000 mg. The total duration of the study treatment for each participant will be approximately 6 weeks. Safety will be evaluated by assessment of adverse events, clinical laboratory tests, skin site assessments, vital signs, and physical examination which will be monitored throughout the study.
- Conditions
- Cancer
- Being tested
- Tramadol HCI/acetaminophen
- Keywords
- Cancer, Chronic Cancer Pain, Tramadol HCI, Acetaminophen, Analgesics, Pain assessment
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tramadol HCI/acetaminophenDrug
Also called Ultracet
Participants will receive tablet of tramadol HCI (37.5 mg)/acetaminophen (325 mg) on Day 1. Participants may increase their daily dosage of study medication is 1 to 2 tablets every 4 to 6 hours as needed for pain relief up to maximum of 8 tablets per day.
| Study group | Role | What they receive |
|---|---|---|
| Tramadol HCI + acetaminophen | Experimental | Not described Receives: Drug: Tramadol HCI/acetaminophen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Brief Pain Inventory (BPI) Pain Severity "Pain at Its Worst" (BPI Item 3) at Day 42
Change from baseline in pain severity was assessed using the Brief Pain Inventory (BPI) questionnaire, specifically "pain at its worst" (BPI item 3) at week 4. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in "pain at its worst".
Measured: Baseline (Day 1) to Day 42
Change from Baseline in Analgesic Effect as Assessed by Brief Pain Inventory (BPI) Item 5 Score
The analgesic effect was assessed by the Brief Pain Inventory (BPI) item 5 "pain on average" using a 0 to 10 numeric rating scale, with 0 being "no pain" and 10 being "pain as bad as you can imagine". Higher scores indicate worsening.
Measured: Baseline (Day 1) to Day 42
Number of Participants With Adverse Events
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Measured: Up to Day 42
Number of Doses of Rescue Medication Over Time
Number of doses of rescue medication over time were assessed. Rescue medications are medicines that are administered to the participants when the efficacy of the study medication is not satisfactory, or the effect of the study medication is too great and is likely to cause a hazard to the participant, or to manage an emergency situation. Supplemental analgesics (medication used to control pain) were used as rescue medication.
Measured: Days 7, 14, 28, 35 and 42
Secondary outcomes (3)
Number of Participants With Patient Global Assessment (PGA)
Participants completed a global assessment with respect to pain control using a 9-point scale (-4 to 4; where, -4=100 percent worse, 0=unchanged and 4=100 percent improvement), safety using 5-point scale (1 to 5; where, 1=no, 2=Mild, 3=Moderate, 4=Severe and 5=most severe side effects) and 5-point overall satisfaction scale (1-5; where, 1=no, 2=mild, 3=moderate, 4=good, 5=excellent).
Measured: Day 42
Number of Participants With Investigator Global Assessment
Investigator completed a global assessment of the participants treatment with respect to pain control using a 9-point scale (-4 to 4; where, -4=100 percent worse, 0=unchanged and 4=100 percent improvement), safety using 5-point scale (1 to 5; where, 1=no, 2=mild, 3=moderate, 4=severe and 5=most severe side effects) and 5-point overall satisfaction scale (1-5; where, 1=no, 2=mild, 3=moderate, 4=good, 5=excellent).
Measured: Day 42
Change From Baseline in Quality of Life (QOL) by Using Functional Assessment of Cancer Therapy General Scale (FACT-G) Total Score at Day 42
FACT-G is the 27 items compilation of general Functional Assessment of Cancer Therapy General Scale questions divided into 4 primary dimension of Quality of life (QOL): Physical Well-Being (PWB; 7 items), Social/Family Well-Being (SFWB; 7 items), Emotional Well-Being (EWB; 6 items) and Functional Well-Being (FWB; 7 items). FACT-G uses 5-point Linkert-type response categories ranging from 0="not at all" to 4="very much" to score. Total FACT-G score is the summation of 4 subscale scores and ranges from 0-108. Higher scores for the scales and subscales indicate better QOL.
Measured: Baseline (Day 1) and Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2013 (estimated)
- Study startJul 2004
- Primary completionApr 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag Ltd.,Thailand
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen-Cilag Ltd.,Thailand Clinical Trial, Study director, Janssen-Cilag Ltd.,Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01968018
- Sponsor's protocol ID
- CR013510
- Other IDs
- TRAMAPANA4001
- Status last verified
- Oct 2013
- First submitted
- 18 Oct 2013
- Last updated
- 23 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Safety and Efficacy of Ultracet in Patients With Chronic Cancer Pain
- ClinicalTrials.gov ID
- NCT01968018
- Acronym / sponsor ID
- CR013510
- Conditions
- Cancer
- Keywords
- Cancer, Chronic Cancer Pain, Tramadol HCI, Acetaminophen, Analgesics, Pain assessment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Janssen-Cilag Ltd.,ThailandIndustry (pharma, biotech, devices)
- Study start
- Jul 2004
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 23 Oct 2013 (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 (painkiller) effectiveness and safety of combination of tramadol HCI (37.5 mg)/acetaminophen (325 mg) in the treatment of chronic cancer pain.
Detailed description
This is an open-label (all people know the identity of the intervention) study. A total of 35 participants will be enrolled in this study. Participants will receive tablet of combination of tramadol HCI (37.5 mg)/acetaminophen (325 mg) on Day 1. Participants may increase their daily dosage of study medication as 1 to 2 tablets every 4 to 6 hours as needed for pain relief, up to maximum of 8 tablets per day. Rescue medication consisting of Extra Strength Tylenol (500 mg) 2 tablets daily for the first six days of the Open-label Phase will be allowed so that the total daily dose of acetaminophen will not exceed 4,000 mg. The total duration of the study treatment for each participant will be approximately 6 weeks. Safety will be evaluated by assessment of adverse events, clinical laboratory tests, skin site assessments, vital signs, and physical examination which will be monitored throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tramadol HCI + acetaminophen | Experimental | Drug: Tramadol HCI/acetaminophen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants whose pain has reached a stage now requiring treatment with a weak opioid, according to the opinion of treating physician
- Participants who have received a regular weak opioid, for at least 48 hours and at a dosage appropriate for their pain at that time
- Participants with a histologically, radiologically or hematologically confirmed malignancy; whose pain is judged by the investigator to be caused by the malignancy
Key exclusion criteria (5 listed)
- Participants who have already received regular treatment with a strong opioid for their cancer pain. This should not exceed more than 3 doses of a strong immediate release opiod in last 7 days, and none in last 24 hours
- Participants with significant abnormalities in hepatic or renal function which would in the opinion of the investigator, prevent the participants involvement in the study
- Participants with a history of allergy or hypersensitivity to tramadol or acetaminophen
- Participants who, at entry have treatments planned which may alter abruptly, the degree or nature of pain experienced (eg radiotherapy, neurological techniques surgery)
- Participants with a history of abuse of opioid analgesics prior to their diagnosis of cancer
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 HCI/acetaminophenAlso: UltracetParticipants will receive tablet of tramadol HCI (37.5 mg)/acetaminophen (325 mg) on Day 1. Participants may increase their daily dosage of study medication is 1 to 2 tablets every 4 to 6 hours as needed for pain relief up to maximum of 8 tablets per day. | Drug | Tramadol HCI + acetaminophen |
Primary outcome
Change From Baseline in Brief Pain Inventory (BPI) Pain Severity "Pain at Its Worst" (BPI Item 3) at Day 42
Time frame: Baseline (Day 1) to Day 42
Change from baseline in pain severity was assessed using the Brief Pain Inventory (BPI) questionnaire, specifically "pain at its worst" (BPI item 3) at week 4. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in "pain at its worst".
Change from Baseline in Analgesic Effect as Assessed by Brief Pain Inventory (BPI) Item 5 Score
Time frame: Baseline (Day 1) to Day 42
The analgesic effect was assessed by the Brief Pain Inventory (BPI) item 5 "pain on average" using a 0 to 10 numeric rating scale, with 0 being "no pain" and 10 being "pain as bad as you can imagine". Higher scores indicate worsening.
Number of Participants With Adverse Events
Time frame: Up to Day 42
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Number of Doses of Rescue Medication Over Time
Time frame: Days 7, 14, 28, 35 and 42
Number of doses of rescue medication over time were assessed. Rescue medications are medicines that are administered to the participants when the efficacy of the study medication is not satisfactory, or the effect of the study medication is too great and is likely to cause a hazard to the participant, or to manage an emergency situation. Supplemental analgesics (medication used to control pain) were used as rescue medication.
3 secondary outcomes
Number of Participants With Patient Global Assessment (PGA)
Time frame: Day 42
Number of Participants With Investigator Global Assessment
Time frame: Day 42
Change From Baseline in Quality of Life (QOL) by Using Functional Assessment of Cancer Therapy General Scale (FACT-G) Total Score at Day 42
Time frame: Baseline (Day 1) and Day 42
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 23 Oct 2013.
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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.
Janssen-Cilag Ltd.,Thailand Clinical Trial study director
Janssen-Cilag Ltd.,Thailand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tramadol HCI/acetaminophen in people with Cancer, run by Janssen-Cilag Ltd.,Thailand at 1 site in Thailand.
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 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 23 Oct 2013. 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 Thailand. 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.
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 in Brief Pain Inventory (BPI) Pain Severity "Pain at Its Worst" (BPI Item 3) at Day 42 (time frame: Baseline (Day 1) to Day 42). The study lists 4 primary outcomes in all. 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 23 Oct 2013.