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| ID | Type | Description | Link |
|---|---|---|---|
| TRAMAPANA4001 | Other Identifier | Janssen-Cilag Ltd.,Thailand |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tramadol HCI + acetaminophen | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tramadol HCI/acetaminophen | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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". | 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. | 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. | 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. | Days 7, 14, 28, 35 and 42 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen-Cilag Ltd.,Thailand Clinical Trial | Janssen-Cilag Ltd.,Thailand | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bangkok | Thailand |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C478659 | Ultracet |
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| 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). | 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. | Baseline (Day 1) and Day 42 |