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

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".

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Days 7, 14, 28, 35 and 42