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RCT Comparing the Analgesic Efficacy of 4 Therapeutic Strategies Based on 4 Different Major Opioids (Fentanyl, Oxycodone, Buprenorphine vs Morphine) in Cancer Patients With Moderate/Severe Pain, at the Moment of Starting 3rd Step of WHO Analgesic Ladder. (CERP)

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ClinicalTrials.gov Identifier: NCT01809106
Recruitment Status : Completed
First Posted : March 12, 2013
Results First Posted : November 20, 2015
Last Update Posted : December 24, 2015
Sponsor:
Information provided by (Responsible Party):
Mario Negri Institute for Pharmacological Research

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Cancer
Cancer Pain
Interventions Drug: Morphine
Drug: Fentanyl
Drug: Buprenorphine
Drug: Oxycodone
Enrollment 518
Recruitment Details Date of First Enrollment: May 2014 Date of last enrollment: July 2014
Pre-assignment Details  
Arm/Group Title Morphine Oxycodone Buprenorphine Fentanyl
Hide Arm/Group Description Morphine: 60 mg /24 ore Oxycodone: 40 mg /24 ore Buprenorphine: 35 microg/h Fentanyl: 25 microg/h
Period Title: Overall Study
Started 130 130 130 128
Completed 122 125 127 124
Not Completed 8 5 3 4
Arm/Group Title Morphine Oxycodone Buprenorphine Fentanyl Total
Hide Arm/Group Description Morphine: 60 mg /24 ore Oxycodone: 40 mg /24 ore Buprenorphine: 35 microg/h Fentanyl: 25 microg/h Total of all reporting groups
Overall Number of Baseline Participants 122 125 127 124 498
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 122 participants 125 participants 127 participants 124 participants 498 participants
67.5  (11.7) 66.9  (11.1) 65.2  (13.5) 68  (10.6) 66.9  (11.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 122 participants 125 participants 127 participants 124 participants 498 participants
Female
55
  45.1%
53
  42.4%
59
  46.5%
54
  43.5%
221
  44.4%
Male
67
  54.9%
72
  57.6%
68
  53.5%
70
  56.5%
277
  55.6%
1.Primary Outcome
Title Proportion of Non-Responder (NR) Participants
Hide Description Evaluation of the proportion of Non-Responder (NR) participants. NR correspond to the subjects who do not report any analgesic effects, with a P.I.D. (pain intensity difference) from visit 6 and visit 1 =/< 0%, (using a 0-10 NRS ). It includes the situations of average pain intensity "stable" or "worsened" at day 28 compared with baseline values.
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat
Arm/Group Title Morphine Oxycodone Buprenorphine Fentanyl
Hide Arm/Group Description:
Morphine: 60 mg /24 ore
Oxycodone: 40 mg /24 ore
Buprenorphine: 35 microg/h
Fentanyl: 25 microg/h
Overall Number of Participants Analyzed 122 125 127 124
Measure Type: Number
Unit of Measure: participants
14 18 14 11
2.Secondary Outcome
Title Proportion of Full-responder
Hide Description Evaluation of the proportion of subjects who report full analgesia (full responders: FR). FR is operationally defined as a patient with a P.I.D. =/> 30% from visit 6 and visit 1 (NRS 0 to 10).
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Morphine Oxycodone Buprenorphine Fentanyl
Hide Arm/Group Description:
Morphine: 60 mg /24 ore
Oxycodone: 40 mg /24 ore
Buprenorphine: 35 microg/h
Fentanyl: 25 microg/h
Overall Number of Participants Analyzed 122 125 127 124
Measure Type: Number
Unit of Measure: participants
89 90 95 88
3.Other Pre-specified Outcome
Title The Opioid Escalation Index
Hide Description The proportion of subjects with an increase of opioid daily dose > 5% compared with the basal dosage (OEI%).
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Morphine Oxycodone Buprenorphine Fentanyl
Hide Arm/Group Description:
Morphine: 60 mg /24 ore
Oxycodone: 40 mg /24 ore
Buprenorphine: 35 microg/h
Fentanyl: 25 microg/h
Overall Number of Participants Analyzed 122 125 127 124
Measure Type: Number
Unit of Measure: participants
13 24 18 45
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Morphine Oxycodone Buprenorphine Fentanyl
Hide Arm/Group Description Morphine: 60 mg /24 ore Oxycodone: 40 mg /24 ore Buprenorphine: 35 microg/h Fentanyl: 25 microg/h
All-Cause Mortality
Morphine Oxycodone Buprenorphine Fentanyl
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
Morphine Oxycodone Buprenorphine Fentanyl
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/122 (4.10%)      1/125 (0.80%)      1/127 (0.79%)      5/124 (4.03%)    
Gastrointestinal disorders         
bowel occlusion  1/122 (0.82%)  1 0/125 (0.00%)  0 0/127 (0.00%)  0 1/124 (0.81%)  1
asthenia  0/122 (0.00%)  0 0/125 (0.00%)  0 0/127 (0.00%)  0 1/124 (0.81%)  1
oral cavity bleeding  0/122 (0.00%)  0 0/125 (0.00%)  0 1/127 (0.79%)  2 0/124 (0.00%)  0
General disorders         
exitus  0/122 (0.00%)  0 0/125 (0.00%)  0 0/127 (0.00%)  0 1/124 (0.81%)  1
decline general condition  0/122 (0.00%)  0 1/125 (0.80%)  1 0/127 (0.00%)  0 1/124 (0.81%)  1
hyperpyrexia  2/122 (1.64%)  2 0/125 (0.00%)  0 0/127 (0.00%)  0 0/124 (0.00%)  0
Hepatobiliary disorders         
hepatic disorder  0/122 (0.00%)  0 0/125 (0.00%)  0 0/127 (0.00%)  0 1/124 (0.81%)  1
Nervous system disorders         
hyperalgesia  1/122 (0.82%)  1 0/125 (0.00%)  0 0/127 (0.00%)  0 0/124 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
dyspnea  1/122 (0.82%)  1 0/125 (0.00%)  0 0/127 (0.00%)  0 1/124 (0.81%)  1
atelectasis  1/122 (0.82%)  1 0/125 (0.00%)  0 0/127 (0.00%)  0 0/124 (0.00%)  0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Morphine Oxycodone Buprenorphine Fentanyl
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   103/122 (84.43%)      98/125 (78.40%)      108/127 (85.04%)      95/124 (76.61%)    
General disorders         
drowsiness  79/122 (64.75%)  79 74/125 (59.20%)  74 81/127 (63.78%)  81 70/124 (56.45%)  70
Confusion  59/122 (48.36%)  59 55/125 (44.00%)  55 61/127 (48.03%)  61 46/124 (37.10%)  46
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Oscar Corli
Organization: Mario Negri Institution
Phone: +390239014564
EMail: oscar.corli@marionegri.it
Publications:
Layout table for additonal information
Responsible Party: Mario Negri Institute for Pharmacological Research
ClinicalTrials.gov Identifier: NCT01809106    
Other Study ID Numbers: Studio CERP
First Submitted: March 8, 2013
First Posted: March 12, 2013
Results First Submitted: October 20, 2015
Results First Posted: November 20, 2015
Last Update Posted: December 24, 2015