Two Step Versus the Standard Three Step Approach of the WHO Analgesic Ladder for Cancer Pain Relief. (TVT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01493635|
Recruitment Status : Completed
First Posted : December 16, 2011
Last Update Posted : May 17, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cancer Pain||Other: analgesic ladder||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||152 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||An International, Multicentre, Open Randomised Parallel Group Trial Comparing a Two Step Approach for Cancer Pain Relief With the Standard Three Step Approach of the WHO Analgesic Ladder in Patients With Cancer Pain Requiring Step 2 Analgesia.|
|Study Start Date :||November 2012|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||March 2016|
Active Comparator: Standard 3 Step approach.
Standard 3 Step approach of the WHO analgesic ladder (Step 1 - Step 2 - Step 3).
Other: analgesic ladder
Patients will be managed according to the standard 3 Step approach of the WHO analgesic ladder (Step 1 - Step 2 - Step 3).
Experimental: 2 Step approach.
2 Step approach of the WHO analgesic ladder (Step 1 - Step 3).
Other: analgesic ladder
Patients managed according to the WHO analgesic ladder bypassing Step 2, i.e. patients will move from Step 1 of the WHO analgesic ladder to Step 3.
- Time to achieving stable pain control, where stable pain control is defined as the first day of three consecutive days with average pain score less than or equal to 3 using scores from the Patient Diary and patient assessments. [ Time Frame: Up to 20 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01493635
|Western General Hospital|
|Edinburgh, United Kingdom, EH4 2XU|
|Principal Investigator:||Marie Fallon||University of Edinburgh|