A Study of Safety and Effectiveness of Ultracet in Patients With Chronic Cancer Pain

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Study of Safety and Efficacy of Ultracet in Patients With Chronic Cancer Pain

Conditions
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Cancer

Intervention / Treatment
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* Drug: Tramadol HCI/acetaminophen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tramadol HCI + acetaminophen<br> | Drug: Tramadol HCI/acetaminophen<br>* 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.<br>* Other names: Ultracet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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). | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Chronic Cancer Pain, Tramadol HCI, Acetaminophen, Analgesics, Pain assessment