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

Phase 1

• 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.

• Registration Number: EUCTR2007-000805-32-GB
• Lead Sponsor: The Royal Marsden NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-03-09
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 80

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).;<br> Secondary Objective: The secondary objectives are:<br> 1.To assess changes in pain scores from baseline on day 2 and day 7 after stopping paracetamol.<br> 2.To establish which groups of patients, or types of pain, benefit from continuing paracetamol.<br> ;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).