Clinical trial · Interventional
A Study of Safety and Effectiveness of Ultracet in Patients With Chronic Cancer Pain
A Study of Safety and Efficacy of Ultracet in Patients With Chronic Cancer Pain
NCT01968018CI-TRIAL-00012442completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tramadol HCI/acetaminophen | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Tramadol HCI + acetaminophen
- interventionNames
- Drug: Tramadol HCI/acetaminophen
Primary outcomes (4)
- measure
- Change From Baseline in Brief Pain Inventory (BPI) Pain Severity "Pain at Its Worst" (BPI Item 3) at Day 42
- timeFrame
- Baseline (Day 1) to Day 42
- description
- 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".
- measure
- Change from Baseline in Analgesic Effect as Assessed by Brief Pain Inventory (BPI) Item 5 Score
- timeFrame
- Baseline (Day 1) to Day 42
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.