AN INVESTIGATION INTO THE ROLE OF PARACETAMOL (ACETAMINOPHEN) AT STEP 3 OF THE WHO ANALGESIC LADDER

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-000805-32-GB

Enrollment

Registered

2007-03-09

Start date

2007-04-03

Completion date

Unknown

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The management of cancer pain in patients on step 3 of the WHO analgesic ladder, ie patients on a regular opioids for moderate to severe pain and paracetamol.

Interventions

Product Name: Paracetamol Pharmaceutical Form:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Clinical diagnosis of cancer. 2. Age =18yr. 3. Taking regular opioids for moderate to severe pain (i.e. 4hrly normal release opioid; 12hourly modified release opioid; or a transdermal patch - step 3 of the WHO analgesic ladder) for the preceding 7 days. 4. Taking = 2g / day paracetamol for the preceding 7 days. 5. Average pain score for the preceding 24hrs =4 on a 0-10 numerical rating scale (NRS). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Unwilling to stop paracetamol 2. No diagnosis of malignant disease. 3. Age <18yr. 4. Prognosis <2weeks. 5. Radiotherapy treatment in the preceding 4 weeks. 6. New anti-cancer treatment in the preceding 4 weeks. 7. Average pain score for the preceding 24hrs =5 on NRS. 8. Significant cognitive impairment, i.e. unable to complete pain questionnaire.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective is to establish how many patients choose to restart their paracetamol having been asked to discontinue it, at completion of the study (day 7).; Secondary Objective: The secondary objectives are: 1. To assess changes in pain scores from baseline on day 2 and day 7 after stopping paracetamol. 2. To establish which groups of patients, or types of pain, benefit from continuing paracetamol. ;Primary end point(s): The primary endpoint is the number of patients choosing to re-start their paracetamol at the end of the study (day 7).	—

Measure

Time frame

Main Objective: The primary objective is to establish how many patients choose to restart their paracetamol having been asked to discontinue it, at completion of the study (day 7).; Secondary Objective: The secondary objectives are: 1. To assess changes in pain scores from baseline on day 2 and day 7 after stopping paracetamol. 2. To establish which groups of patients, or types of pain, benefit from continuing paracetamol. ;Primary end point(s): The primary endpoint is the number of patients choosing to re-start their paracetamol at the end of the study (day 7).

—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026